Infectious Disease

Intranasal RNA therapy shows promise against SARS-CoV-2 with dual-targeting approach

A novel intranasal nanomedicine targeting SARS-CoV-2 shows partial viral load reduction in mice, utilizing hpDNAs and baicalein.

FDA Grants AP Status for Zydus' Linezolid ANDA206097

The FDA has granted Abbreviated Approval (AP) status for Zydus Pharmaceuticals' ANDA206097 for Linezolid.

Phase III Trial Shows Safe Co-Administration of PCV15 and DTaP in Infants

A phase III trial demonstrated that co-administration of PCV15 and DTaP in infants is safe and immunogenic, with no significant adverse interactions.

FDA Submission Overview for Dolutegravir, Lamivudine, and Tenofovir Disoproxil Fumarate

The FDA has received a new drug application (NDA219804) for a combination therapy including Dolutegravir, Lamivudine, and Tenofovir Disoproxil Fumarate.

New Pneumococcal Vaccine Study Initiated for Adults Aged 18 and Older

A study is underway to evaluate the safety and immune response of new pneumococcal vaccine candidates in adults, including those aged 50 and older.

FDA Grants Approval for Voriconazole Generic by Zhejiang Novus

The FDA has granted approval for the generic version of Voriconazole under application ANDA220078, submitted by Zhejiang Novus.

Phase 1/2 Study of GS-4321 in Healthy and Chronic Hepatitis Delta Participants

The study aims to assess the safety, tolerability, and pharmacokinetics of GS-4321 in healthy participants, followed by its efficacy in chronic hepatitis delta patients.

FDA Approves Supplement for VEKLURY (Remdesivir) by Gilead Sciences

The FDA has approved a supplemental application for VEKLURY (remdesivir) submitted by Gilead Sciences.

Study on Multivirus CTL for Viral Infections Post Allogeneic SCT Shows Promise

A study is investigating the use of banked virus-specific T cells (VSTs) to treat persistent viral infections after allogeneic stem cell transplants.

Trial on Short-Course Antibiotics for Cholangitis Aims for Non-Inferiority

A multicentre randomized controlled trial is investigating the efficacy of a one-day antibiotic course for cholangitis compared to a standard 4-7 day course.

Recombinant zoster vaccine shows feasibility and safety in cancer patients on systemic therapy

A study found that the recombinant zoster vaccine (RZV) is feasible and well tolerated in cancer patients undergoing systemic therapy, with no severe adverse events reported.

Study on Rifapentine and Isoniazid for TB Prevention in Children Under 13

A clinical trial is underway to evaluate the safety and efficacy of daily Rifapentine combined with Isoniazid for tuberculosis prevention in children under 13, including those with HIV.

European Commission Approves Pfizer-BioNTech XFG-adapted COVID-19 Vaccine for 2026-2027

The European Commission has granted marketing authorization for the Pfizer-BioNTech XFG-adapted COVID-19 vaccine for individuals 6 months and older.

Study on Multimorbidity and Polypharmacy in HIV Patients in Basque Country

A study aims to assess the prevalence of multimorbidity and polypharmacy among HIV patients compared to a control group.

Expanded Access Study for Bulevirtide in Chronic Hepatitis Delta Virus Infection

An expanded access study for bulevirtide aims to provide treatment to eligible patients with chronic hepatitis delta virus infection.

Study on NTM Treatment Toxicity in Cancer Patients Highlights Treatment Gaps

A study is investigating the toxicity of treatments for non-tuberculous mycobacterial infections in cancer patients, revealing a potential under-treatment issue.

FDA Accepts Supplemental NDA for DYNA-HEX 2 by XTTRIUM

The FDA has accepted a supplemental NDA for DYNA-HEX 2, which contains chlorhexidine gluconate.

FDA Accepts Supplement for DYNA-HEX 4 by XTTRIUM

The FDA has accepted a supplemental application for DYNA-HEX 4, containing chlorhexidine gluconate.

Phase 1 Study of LAI MMV055 and MMV371 in Healthy Participants Initiated

A Phase 1 single ascending dose study is underway to evaluate the safety and pharmacokinetics of LAI MMV055 alone and in combination with MMV371 in healthy participants.

FDA Approves Supplemental Application for Brexafemme (Ibrexafungerp) by GlaxoSmithKline

The FDA has approved a supplemental application for Brexafemme, an antifungal treatment.

LumiraDx UK Limited Evaluates POC Test for COVID-19 Symptoms

LumiraDx UK Limited is conducting a trial to evaluate a point-of-care test for COVID-19 using nasal and blood samples.

FDA Accepts Supplement for DYNA-HEX 2 by XTTRIUM

The FDA has accepted a supplemental application for DYNA-HEX 2, containing chlorhexidine gluconate.

FDA Accepts Supplement for Brexafemme (Ibrexafungerp) by GlaxoSmithKline

The FDA has accepted a supplemental application for Brexafemme, an antifungal treatment.

FDA Approves Supplemental Application for KALETRA by AbbVie

The FDA has approved a supplemental application for KALETRA, a combination of Lopinavir and Ritonavir, submitted by AbbVie.

FDA Accepts Supplemental Application for Norvir (Ritonavir) by AbbVie

The FDA has accepted a supplemental application for Norvir (Ritonavir) submitted by AbbVie.

FDA Approval Update for AUGMENTIN '875' Submission

The FDA has accepted a supplemental application for AUGMENTIN '875' from US ANTIBIOTICS.

Study on Alcohol Reduction in TB and HIV Patients in India

The HATHI study aims to evaluate a behavioral intervention to reduce alcohol use among individuals with TB and HIV in India.

Pfizer's Study on Itraconazole's Effect on PF-08642534 Pharmacokinetics

Pfizer is conducting a study to evaluate how itraconazole affects the pharmacokinetics of PF-08642534 in healthy adults.

FDA Accepts Supplement Application for METRO I.V. by B BRAUN

The FDA has accepted a supplemental application for METRO I.V. containing metronidazole from B BRAUN.

FDA Accepts NDA for IDVYNSO Containing Doravirine and Islatravir

The FDA has accepted the New Drug Application (NDA) for IDVYNSO, which includes doravirine and islatravir.

Study on Neurodevelopmental Outcomes After In Utero Lyme Disease Exposure Launched

A pilot study has been initiated to evaluate the neurodevelopmental outcomes of infants exposed to Lyme disease in utero.

NIH Study to Evaluate Hepatitis C Virus Infection in Blood Donors

The NIH is conducting a study to assess the infectivity and natural history of Hepatitis C Virus (HCV) among blood donors who test positive for antibodies.

Trial Comparing Glucantime Alone vs. with CO2 Laser for Cutaneous Leishmaniasis

A randomized controlled trial is underway to assess the efficacy of intralesional Glucantime alone versus in combination with fractional CO₂ laser therapy for cutaneous leishmaniasis.

Study to Establish Bordetella Pertussis Infection Model in Healthy Adults

A study is underway to establish Controlled Human Infection Model for Bordetella pertussis, focusing on a safe infectious dose.

Columbia University Launches Effectiveness Trial for WINGS+PrEP Combination

The WINGS+PrEP study aims to compare the effectiveness of a combined intervention versus standard PrEP in improving adherence and reducing HIV risks.

NIAID Study on HIV Pathogenesis Using Human Blood Cells

A study is underway to investigate the virologic and immunologic parameters of HIV infection using human peripheral blood cells.

FDA Accepts Supplement Application for Artesunate by Amivas

The FDA has accepted a supplemental application for Artesunate (NDA213036) submitted by Amivas.

Brii Biosciences Initiates Study on BRII-835 and BRII-179 for Chronic HBV Infection

Brii Biosciences is conducting a study to evaluate the safety and efficacy of BRII-835 and BRII-179 in treating chronic HBV infection.

Nanovaccines Show Superior Efficacy Over Ampicillin in Preventing Neonatal Listeriosis

Nanovaccines demonstrated greater efficacy than ampicillin in preventing neonatal listeriosis in a mouse model.

Merck's Access Plans for Alimatravir in HIV PrEP Targeting Low-Income Countries

Merck announced initial access plans for alimatravir, an investigational HIV PrEP, focusing on low- and middle-income countries.

Study on HIV-1 Replication During Long-term Antiretroviral Therapy Initiated

A study is underway to analyze HIV-1 replication levels in patients on long-term antiretroviral therapy and assess potential mutations.

FDA Grants Approval for Dalbavancin Hydrochloride ANDA219604

The FDA has granted approval for the ANDA219604 application for Dalbavancin Hydrochloride submitted by BE PHARMS.

FDA Approves Augmentin '875' Supplement Application

The FDA has approved a supplemental application for Augmentin '875' submitted by US Antibiotics.

Watson Labs receives AP status for Ciprofloxacin Hydrochloride ANDA076794

Watson Labs has received an Abbreviated Approval (AP) for its ANDA076794 application for Ciprofloxacin Hydrochloride.

FDA Approval Update for Ciprofloxacin Hydrochloride by Hikma

Hikma has received an Abbreviated New Drug Application (ANDA) approval for Ciprofloxacin Hydrochloride.

Torrent's Moxifloxacin Hydrochloride ANDA Receives Approval Status

Torrent's ANDA for Moxifloxacin Hydrochloride has received an approval status (AP) from the FDA.

FDA Grants Approval for Doxycycline Hyclate ANDA210527 by Alembic

The FDA has granted approval for Alembic's Abbreviated New Drug Application for Doxycycline Hyclate.

FDA Accepts Supplement Application for REZZAYO (Rezafungin Acetate)

The FDA has accepted a supplemental application for REZZAYO, an antifungal agent containing Rezafungin Acetate.

FDA Accepts Supplemental Application for ZITHROMAX by Pfizer

The FDA has accepted a supplemental application for ZITHROMAX (azithromycin) from Pfizer.

Sagent Pharmaceuticals' Clindamycin Phosphate ANDA090108 Receives AP Status

Sagent Pharmaceuticals has received an Abbreviated New Drug Application (ANDA) approval status for Clindamycin Phosphate.

FDA Grants AP Status for Clindamycin Phosphate ANDA090109

The FDA has granted approval status (AP) for ANDA090109, a supplemental application for Clindamycin Phosphate by Sagent Pharmaceuticals.

FDA Accepts Supplemental NDA for Zithromax by Pfizer

The FDA has accepted a supplemental NDA for Zithromax (azithromycin) submitted by Pfizer.

Islatravir and Lenacapavir Show Sustained Virologic Suppression in Phase 3 HIV Trials

Phase 3 ISLEND trials demonstrated high rates of virologic suppression at week 48 for the ISL/LEN regimen.

Study on Diagnostic Methods for Pulmonary Nontuberculous Mycobacterial Infection

A study is comparing different methods of sample collection to improve diagnosis of pulmonary nontuberculous mycobacterial infection.

FDA Accepts Application for XOCOVA (Ensitrelvir) by Shionogi

The FDA has accepted the New Drug Application for XOCOVA, an antiviral drug containing Ensitrelvir.

FDA Grants Priority Review for ZAYNICH NDA Submission by Wockhardt Bio AG

The FDA has granted priority review for the NDA submission of ZAYNICH, containing cefepime hydrochloride and zidebactam.

FDA Approves Supplement for Voriconazole by Hainan Poly Pharm

The FDA has approved a supplemental application for Voriconazole submitted by Hainan Poly Pharm.

Ketamine Trial for Long COVID Symptoms Shows Promise for Fatigue and Brain Fog

A clinical trial is evaluating the efficacy of ketamine in treating Long COVID symptoms, particularly fatigue and cognitive issues.

Phase 1 Trial of mRNA HIV Vaccines DV700P-RNA and DV701B1.1-RNA Initiated

A phase 1 trial is underway to assess the safety and immune response of two mRNA vaccines in HIV-positive adults.

FDA Grants AP Status for Clindamycin Phosphate Supplement by ALMAJECT

The FDA has granted an Abbreviated New Drug Application (ANDA) approval status for a supplement of Clindamycin Phosphate submitted by ALMAJECT.

FDA Grants AP Status for Clindamycin Phosphate Supplement by ALMAJECT

The FDA has granted approval status (AP) for the supplemental application ANDA062801 for Clindamycin Phosphate submitted by ALMAJECT.

FDA Grants AP Status for Clindamycin Phosphate Supplement by ALMAJECT

The FDA has granted an Abbreviated New Drug Application (ANDA) AP status for a supplement of Clindamycin Phosphate submitted by ALMAJECT.

FDA Grants AP Status for Doxycycline ANDA202778 by Strides Pharma

The FDA has granted Abbreviated Approval (AP) status for the Doxycycline ANDA202778 submitted by Strides Pharma.

FDA Approval Status Update for Cleocin (Clindamycin Palmitate Hydrochloride)

The FDA has updated the submission status for Cleocin, indicating an Abbreviated New Drug Application (ANDA) approval process.

FDA Approves Supplement for Biktarvy by Gilead Sciences

The FDA has approved a supplemental application for Biktarvy, a combination therapy for HIV.

FDA Accepts Supplement for Meropenem by ACS DOBFAR

The FDA has accepted a supplemental application for Meropenem submitted by ACS DOBFAR.

FDA Accepts Supplement Application for Clindamycin Phosphate by Encube

The FDA has accepted a supplemental application (ANDA212438) for Clindamycin Phosphate submitted by Encube.

Genex with Gentamicin Trial for Osteomyelitis Shows Promise in Surgical Treatment

A pivotal trial is underway to assess the safety and efficacy of Genex with Gentamicin for treating osteomyelitis.

Otsuka's OPC-167832 Trial for Drug-Susceptible TB Shows Promise Against Standard Regimen

A trial is underway to evaluate the safety and efficacy of OPC-167832 in combination with delamanid and bedaquiline for drug-susceptible TB.

GSK's Bepirovirsen Study Targets HIV/HBV Co-Infection Efficacy and Safety

GlaxoSmithKline is conducting a study to evaluate the efficacy and safety of bepirovirsen in HIV/HBV co-infected participants.

Dalbavancin vs Standard Therapy in Endocarditis: A Comparative Study

A clinical trial is underway to compare the efficacy and tolerability of dalbavancin against standard antibiotic therapy for infective endocarditis.

ViiV Healthcare initiates first-in-human trial for antiretroviral VH4770359

ViiV Healthcare is conducting a first-in-human study to assess the safety and pharmacokinetics of VH4770359.

NIAID Initiates Phase A/B Trial for Experimental H1N1 Influenza Vaccine BPL-1357

The National Institute of Allergy and Infectious Diseases is testing an experimental flu vaccine, BPL-1357, in a two-phase clinical trial involving healthy adults.

Trial on Dressing Strategies to Prevent MARSI in CVCs

A clinical trial is underway to compare three dressing securement strategies for central venous catheters to prevent MARSI.

BCG Vaccine: Intravenous Administration Shows Superior Efficacy Over Traditional Routes

Recent studies suggest that intravenous administration of BCG vaccine offers better protection against tuberculosis than traditional cutaneous methods.

Merck to Present New Data on HIV Treatment Options at AIDS 2026

Merck will present new data on investigational once-weekly oral combinations of islatravir with lenacapavir and ulonivirine at AIDS 2026.

FDA Grants Approval for Cefixime ANDA218691 by FDC LTD

The FDA has granted approval for the Abbreviated New Drug Application (ANDA) 218691 for Cefixime submitted by FDC LTD.

Study on Behavioral Economics to Enhance ART Adherence in HIV Patients

The INMIND study aims to improve long-term adherence to antiretroviral treatment using behavioral economics.

FDA Approves Supplemental Application for Zithromax (Azithromycin)

The FDA has approved a supplemental application for Zithromax (Azithromycin) submitted by Pfizer.

FDA Approves Supplemental Application for Zithromax by Pfizer

The FDA has approved a supplemental application for Zithromax (azithromycin) submitted by Pfizer.

FDA Accepts Supplement for Zithromax (Azithromycin) by Pfizer

The FDA has accepted a supplemental application for Zithromax (azithromycin) from Pfizer.

Phase 2 Study Shows Safety and Enhanced Immunogenicity of mRNA-1010 Influenza Vaccine

The phase 2 study of mRNA-1010 demonstrated safety and enhanced immune responses against influenza B strains.

FDA Approves Supplemental Application for Zithromax by Pfizer

The FDA has approved a supplemental application for Zithromax (Azithromycin) submitted by Pfizer.

FDA Grants Approval for Rilpivirine Hydrochloride ANDA219788

The FDA has granted approval for the ANDA219788 application for Rilpivirine Hydrochloride submitted by Laurus.

FDA Accepts Supplement Application for NUZYRA (Omadacycline Tosylate)

The FDA has accepted a supplemental application for NUZYRA, indicating ongoing development and potential label expansion.

FDA Grants Approval for Foscarnet Sodium ANDA220068 by Caplin

The FDA has granted approval for the Abbreviated New Drug Application (ANDA) 220068 for Foscarnet Sodium submitted by Caplin.

Study on Genetic Mutations in Chronic Active Epstein-Barr Disease Launched

A new study aims to identify genetic mutations linked to Chronic Active Epstein-Barr Virus (CAEBV) in patients and their relatives.

FDA Grants AP Status for Watson Labs' Minocycline Hydrochloride

The FDA has granted approval status (AP) for Watson Labs' ANDA063181 for Minocycline Hydrochloride.

Study on Shingrix Vaccine Response in HIV Patients and Healthy Controls

A clinical trial is investigating the safety and immunogenicity of the Shingrix vaccine in individuals with HIV and healthy controls.

Long-Term Study on Cabotegravir Plus Rilpivirine Effectiveness in HIV Patients

The RELATIVITY study evaluates long-term effectiveness and safety of CAB+RPV LA in HIV patients in Spain over five years.

BioNTech's mRNA Mpox Vaccine Candidate Enters Clinical Trial Phase

BioNTech SE is conducting a randomized clinical trial to evaluate the safety and immunogenicity of its mRNA-based Mpox vaccine candidate.

FDA Submission for Tenofovir Alafenamide Fumarate by Laurus Labs

Laurus Labs has submitted an ANDA for Tenofovir Alafenamide Fumarate, currently under standard review.

FDA Grants Approval for Dapsone ANDA218335 by Macleods Pharmaceuticals

The FDA has granted approval for the Abbreviated New Drug Application (ANDA) 218335 for Dapsone submitted by Macleods Pharmaceuticals.

FDA Grants Priority Review for ZERBAXA Supplement by Cubist Pharmaceuticals

The FDA has granted priority review status for the supplemental NDA for ZERBAXA, which includes cefotolozane sulfate and tazobactam sodium.

DisCoVeRy Trial Evaluates AZD7442 for COVID-19 in Hospitalized Adults

The DisCoVeRy trial is now evaluating AZD7442 in hospitalized COVID-19 patients, comparing it to standard of care plus placebo.

FDA Submission for Dolutegravir, Lamivudine, and Tenofovir Disoproxil Fumarate

The FDA has received a new drug application (NDA219804) for a combination therapy of Dolutegravir, Lamivudine, and Tenofovir Disoproxil Fumarate from Aspen SA Operations.

Kaiser Permanente Trials Educational Video to Improve LTBI Treatment Completion

A randomized trial will assess the impact of a 3-minute educational video on LTBI treatment completion rates.

High-Dose Quadrivalent Influenza Vaccine Shows Superior Immunogenicity in Young Children

Pfizer Initiates Study on New Pneumococcal Vaccine for Infants

Pfizer is conducting a study to evaluate the safety and efficacy of a new pneumococcal vaccine (PG4) in infants compared to the existing Prevnar 20® vaccine.

Phase II Trial Shows Comparable Immunogenicity of GSK's Investigational MMRV Vaccine

GSK's investigational MMRV vaccine demonstrated comparable immunogenicity and safety to the licensed MMRV vaccine in Phase II trial.

FDA Grants Approval for Voriconazole ANDA220078 by Zhejiang Novus

The FDA has granted an Abbreviated New Drug Application (ANDA) approval for Voriconazole submitted by Zhejiang Novus.

NIAID Launches Study on Natural History of Tuberculosis with Active Recruitment

The National Institute of Allergy and Infectious Diseases is recruiting individuals with active or latent tuberculosis for a study on the disease's natural history.

Study on Herpesvirus Reactivation in HIV-Infected Women Initiating ART

A study is being conducted to investigate herpes virus reactivation in women with HIV starting ART.

HEC116094 Shows Potent Activity as PB2 Inhibitor Against Influenza A Virus

HEC116094 demonstrates potent in vitro and in vivo activity against influenza A virus, outperforming existing therapies.

FDA Accepts Supplement for SPORANOX (Itraconazole) by Janssen

The FDA has accepted a supplemental application for SPORANOX, an antifungal medication containing itraconazole.

FDA Grants Approval for Aciclovir ANDA215669 by Hetero Labs

The FDA has granted approval for the Abbreviated New Drug Application (ANDA) 215669 for aciclovir submitted by Hetero Labs.

Identification of Bakuchiol as Potent Bacterial Neuraminidase Inhibitor from Psoralea corylifolia

Bakuchiol was identified as a potent inhibitor of bacterial neuraminidase with an IC50 of 4.67 μM, outperforming quercetin.

FMT Shows Promise in Restoring Gut Microbiome in Antibiotic-Treated Sepsis Patients

Fecal microbiota transplantation (FMT) significantly improved gut microbiome diversity in antibiotic-treated sepsis patients compared to probiotics.

Post-marketing study shows cholera vaccine reduces diarrhea incidence in children

A phase III trial indicates the cholera vaccine reduced diarrhea incidence from 26.7% to 12.9% in vaccinated children.

Bristol Laboratories recalls Phenoxymethylpenicillin due to labeling issues

Bristol Laboratories Limited is recalling batch 7124002 of Phenoxymethylpenicillin 250 mg/5 ml Oral Solution due to labeling issues.

Pfizer's Ibuzatrelvir Study Targets High-Risk COVID-19 Patients

Pfizer is conducting a study to evaluate the safety and efficacy of ibuzatrelvir in non-hospitalized adults and adolescents with COVID-19 at risk of severe disease.

FDA Acceptance of Supplemental NDA for FETROJA by Shionogi

The FDA has accepted a supplemental NDA for FETROJA (cefiderocol sulfate tosylate) from Shionogi.

Study on Burden of Hospitalized Patients with Respiratory Tract Infections in Dutch Hospitals

A multicenter retrospective study will assess hospitalization rates and healthcare resource utilization for RTIs in Dutch hospitals.

Sanaria Inc. Initiates PfSPZ-LARC2 Vaccine Trial for Women in Mali

Sanaria Inc. is conducting a randomized trial to evaluate the safety and efficacy of the PfSPZ-LARC2 vaccine in women of child-bearing potential in Mali.

Novitium Pharma's Aciclovir ANDA212252 Receives AP Status from FDA

The FDA has granted an Abbreviated New Drug Application (ANDA) approval status of 'AP' for Novitium Pharma's acyclovir.

Aurobindo Pharma's Aciclovir ANDA216331 Receives AP Status from FDA

Aurobindo Pharma's Abbreviated New Drug Application (ANDA) for Aciclovir has received an Approved Pending (AP) status from the FDA.

Advances in NSP13 helicase inhibitors for broad-spectrum anti-coronavirus therapy

NSP13 helicase is a promising target for broad-spectrum anti-coronavirus drugs, with recent progress in inhibitor development.

FDA Grants AP Status for Acyclovir ANDA212718 by Chartwell RX

The FDA has granted an Abbreviated New Drug Application (ANDA) approval status of 'Approved' for Acyclovir submitted by Chartwell RX.

ACTAVIS Mid Atlantic's Aciclovir ANDA074738 Receives AP Status

The FDA has granted an Abbreviated New Drug Application (ANDA) approval status of 'Approved' for ACTAVIS MID ATLANTIC's acyclovir.

FDA Grants Approval for Acyclovir ANDA213951 by Vistapharm

The FDA has granted approval for the ANDA213951 application for Acyclovir submitted by Vistapharm LLC.

FDA Grants Approval for Novitium Pharma's Rifampin ANDA219918

The FDA has granted approval for Novitium Pharma's Abbreviated New Drug Application for Rifampin.

FDA Accepts ANDA for Posaconazole by Apotex

The FDA has accepted the Abbreviated New Drug Application (ANDA) for Posaconazole submitted by Apotex.

Study on Sepsis-Associated Acute Lung Injury from Hypervirulent Klebsiella Pneumoniae Launched

A prospective observational study will assess the risk of sepsis-associated acute lung injury from hypervirulent Klebsiella pneumoniae compared to classical strains.

Shionogi's S-337395 Trial Targets High-Risk RSV Patients

A clinical trial is underway to evaluate the antiviral efficacy of S-337395 in nonhospitalized adults at high risk for severe RSV.

Economic Review of Nirmatrelvir/Ritonavir for COVID-19 Health Outcomes

The systematic literature review evaluates health-related outcomes of nirmatrelvir/ritonavir treatment for COVID-19.

Phase I/II Trial of EXL01 to Prevent Clostridioides Difficile Infection Recurrence

A Phase I/II trial is evaluating the efficacy and safety of EXL01, an isolated strain of F. prausnitzii, for preventing CDI recurrence in high-risk patients.

Linezolid shows potential as adjunctive treatment for NTM infections in immunodeficiency patients

Linezolid may improve treatment outcomes for patients with nontuberculous mycobacterial infections linked to adult-onset immunodeficiency syndrome.

Boehringer Ingelheim's BI 764198 Trial Examines Formulation Impact on Bioavailability

The trial will assess the bioavailability of BI 764198 in different formulations and with food effects in healthy men.

FDA Authorizes Baricitinib and Remdesivir Combination for COVID-19 Treatment

The FDA has granted emergency use authorization for baricitinib combined with remdesivir for treating COVID-19 in hospitalized patients.

FDA Warns of Drug Interaction Reducing Remdesivir Effectiveness in COVID-19 Treatment

The FDA has identified a potential drug interaction that may reduce the effectiveness of remdesivir, an authorized treatment for severe COVID-19.

FDA Grants Emergency Use Authorization for Remdesivir in Severe COVID-19 Cases

The FDA has authorized remdesivir for emergency use in hospitalized patients with severe COVID-19.

FDA Authorizes Gohibic (vilobelimab) for COVID-19 Treatment

The FDA has authorized Gohibic (vilobelimab) injection for the treatment of COVID-19.

FDA Approves Veklury as First Treatment for COVID-19

The FDA has approved Veklury (remdesivir) as the first treatment for COVID-19 in hospitalized patients.

Vaxcyte Initiates Study on VAX-31 for Adults Over 50 with Prior Pneumococcal Vaccination

Vaxcyte, Inc. is conducting a study to assess the safety, tolerability, and immunogenicity of VAX-31 in older adults.

Evaluation of LTBI Screening Methods in HIV Patients in Liberia

A study is underway to compare IGRA and TST for latent TB screening in HIV-positive individuals in Liberia.

FDA Accepts Supplement for METRO I.V. in Plastic Container by B BRAUN

The FDA has accepted a supplemental application for METRO I.V., which contains metronidazole, by B BRAUN.

Study on Integrons to Reduce Broad-Spectrum Antibiotic Use in UTIs

The INVICTUS project aims to evaluate the role of integrons in reducing broad-spectrum antibiotic use for non-severe UTIs.

FDA Accepts NDA for IDVYNSO Containing Doravirine and Islatravir

The FDA has accepted the New Drug Application for IDVYNSO, which includes doravirine and islatravir.

ViiV Healthcare Compares Two-Drug vs Three-Drug Regimen in HIV Treatment Study

A study is underway to evaluate the efficacy and safety of a two-drug regimen versus a three-drug regimen in treatment-naive HIV-1 patients.

Impax Labs Receives AP Status for Tetracycline Hydrochloride ANDA060469

Impax Labs has received an Abbreviated Approval (AP) for their ANDA060469 submission for Tetracycline Hydrochloride.

Study shows no autoantibody induction post-BNT162b2 boost in CoronaVac-primed individuals

No significant changes in autoantibody profiles were observed 26 weeks after BNT162b2 boosting in individuals primed with CoronaVac.

Phase 1/2 Trial Shows Safety and Immunogenicity of COVID-19-Influenza Combination Vaccine

The COVID-19-Influenza Combination nanoparticle vaccine (CIC) demonstrated safety and immunogenicity comparable to standalone vaccines in a phase 1/2 trial.

Study Reveals GES Variants Impact Resistance to Ceftazidime-Avibactam and Imipenem-Relebactam

Distinct GES variants influence resistance patterns to ceftazidime-avibactam and imipenem-relebactam in CRPA.

Phase III Trial Shows Non-Inferior Immunogenicity of PCV-Free Rotavirus Vaccine in Infants

The Phase III trial demonstrated that the PCV-free Rotarix vaccine achieved non-inferior seroconversion rates compared to the original Rotarix.

Study Evaluates eDOT vs Traditional DOT for TB Treatment Adherence

A randomized controlled trial is assessing the non-inferiority of electronic DOT compared to traditional DOT for TB treatment adherence.

FDA Accepts Supplement Application for ZEVTERA (Ceftobiprole Medocaril Sodium)

The FDA has accepted a supplemental application for ZEVTERA, indicating a potential expansion of its use.

FDA to Terminate Emergency Use Authorizations for COVID-19 Drugs

The HHS Secretary has determined that the emergency use authorizations for COVID-19 drugs will be terminated.

Flamingo Pharma recalls Flucloxacillin Capsules due to incorrect patient information leaflet

Flamingo Pharma UK Ltd has recalled certain packs of Flucloxacillin Capsules BP 500mg due to containing the incorrect patient information leaflet for Amoxicillin.

FDA Accepts Supplemental Application for ZEVTERA (Ceftobiprole Medocaril Sodium)

The FDA has accepted a supplemental application for ZEVTERA, indicating potential new uses or indications.

FDA Accepts Supplement Application for ARIKAYCE Kit by Insmed

The FDA has accepted a supplemental application for the ARIKAYCE Kit, which contains amikacin sulfate.

FDA Approves Supplement for Bicillin L-A by King Pharmaceuticals

The FDA has granted approval for a supplemental application for Bicillin L-A, containing Penicillin G Benzathine.

FDA Approves Dapsone ANDA213414 by Alembic

The FDA has approved ANDA213414 for Dapsone submitted by Alembic.

Alembic's Oseltamivir Phosphate ANDA Submission Receives AP Status

Alembic's ANDA for Oseltamivir Phosphate has been granted Abbreviated Approval (AP) status by the FDA.

FDA Accepts Supplement for Aciclovir ANDA210401 by Yiling

The FDA has accepted a supplemental application for Aciclovir under ANDA210401 submitted by Yiling.

FDA Grants Approval for Aciclovir ANDA212173 by YILING

The FDA has granted approval for the Abbreviated New Drug Application (ANDA) 212173 for acyclovir submitted by YILING.

Phase 3 Trial of ROTAVAC 5D Vaccine in Chilean Infants Underway

A phase 3 trial is evaluating the efficacy and safety of ROTAVAC 5D, a live attenuated rotavirus vaccine, in 5800 healthy infants.

Merck Partners with ADAP to Enhance Access to IDVYNSO for HIV Treatment

Merck has entered an agreement with the ADAP Crisis Task Force to improve access to IDVYNSO™ for individuals living with HIV.

Cost-Effectiveness of Adjuvanted Influenza Vaccine in Older Adults in the Netherlands

Replacing the standard influenza vaccine with the adjuvanted version in older adults could save €4.3-12.8 million and gain 2,220-6,659 QALYs.

Study Evaluates HIV Treatment Strategies for Opioid Users in Malaysia

A pragmatic study is assessing strategies to enhance HIV treatment outcomes among people with opioid use disorder in Malaysia.

Brancaster Pharma Issues Class 4 Medicines Defect Notification for Benzylpenicillin

Brancaster Pharma Limited reported that certain batches of Benzylpenicillin benzathine were released with an outdated Patient Information Leaflet.

Microneedle Delivery of Amphotericin B Shows Promise for American Cutaneous Leishmaniasis Treatment

Microneedle-based delivery of Amphotericin B significantly reduced lesion growth in mice with American cutaneous leishmaniasis.

Aurobindo Pharma's Aciclovir Supplement Application Receives Standard Review Status

Aurobindo Pharma USA has submitted a supplement application for Aciclovir (ANDA075211) which is currently under standard review by the FDA.

Clinical Trial to Reduce Hepatitis B Vertical Transmission in Africa

The REVERT-B study aims to test antiviral medication in high-risk pregnant women and newborns to prevent hepatitis B transmission.

Hexavalent DTaP-IPV-HB-Hib Vaccine Shows Immunogenicity in Preterm Infants

A phase IV trial in Spain found that a 2 + 1 schedule of the hexavalent DTaP-IPV-HB-Hib vaccine is immunogenic and well tolerated in preterm infants.

Clinical Trial for LB-DTK-MV in Antiviral-Resistant Infections Post-Anticancer Therapy

A clinical trial is underway to evaluate the safety and efficacy of LB-DTK-MV in patients with antiviral-resistant CMV, BKV, or EBV infections following anticancer therapy.

Moderna initiates safety and immunogenicity study for RSV vaccines in infants

Moderna is conducting a study to evaluate the safety and immunogenicity of two mRNA vaccines targeting RSV and hMPV in infants.

Study on Patient Navigation Models for HIV Treatment in Criminal Justice Populations

The study compares two models of care for HIV treatment initiation among criminal legal involved populations.

FDA Grants Approval for Rifapentine ANDA217042 by Macleods Pharmaceuticals

The FDA has granted approval for the ANDA217042 application for Rifapentine submitted by Macleods Pharmaceuticals.

Prospective Study on Skull Base Osteomyelitis Management Initiated

A prospective study on skull base osteomyelitis management has been initiated by Assistance Publique - Hôpitaux de Paris.

V116 shows safety and immunogenicity in high-risk children for pneumococcal disease

The phase 3 study demonstrated that V116 met noninferiority and superiority criteria for immunogenicity compared to PPSV23 in children with chronic conditions.

Sanofi's Nirsevimab Study to Assess RSV Immunisation Rates in Queensland Infants

A study sponsored by Sanofi aims to determine nirsevimab immunisation rates among infants in Queensland during the RSV season.

FDA Approves First Generic of Priftin (rifapentine) Tablets

The FDA has approved the first generic version of Priftin (rifapentine) tablets for treating active pulmonary tuberculosis.

mRNA-LNP Vaccine TP0435 Shows Promise Against Syphilis in Animal Models

The TP0435 mRNA-LNP vaccine demonstrated strong protective immunity against Treponema pallidum in rabbits, outperforming protein vaccines.

Study on Malaria Infection Factors in Pregnant Women and Children in Mali

A longitudinal study will enroll up to 2000 pregnant women and their infants, and 2000 children aged 0-3 years to investigate malaria susceptibility.

FDA Grants Priority Review for UTEBZI (TEBIPENEM, PIVOXIL) by GlaxoSmithKline

The FDA has granted priority review status for NDA215960 for UTEBZI, an antibiotic containing TEBIPENEM and PIVOXIL.

FDA Approves Baloxavir Marboxil for ANDA217449

The FDA has approved Baloxavir Marboxil under ANDA217449 submitted by Norwich.

Phase 1 Trial of OCU500 Vaccine Shows Safety and Immunogenicity in Adults

A phase 1 trial is underway to assess the safety and immunogenicity of the OCU500 vaccine in previously vaccinated adults.

Challenges in Rotavirus Vaccine Efficacy in Low- and Middle-Income Countries

Rotavirus vaccine efficacy is significantly lower in low- and middle-income countries (45-65%) compared to high-income countries (85-90%).

FDA Accepts Supplement for Atovaquone by Hetero Labs

The FDA has accepted a supplemental application for Atovaquone from Hetero Labs.

Glenmark's Atovaquone ANDA209685 Receives Abbreviated Approval

Glenmark Specialty has received abbreviated approval for their ANDA209685 application for Atovaquone.

New Non-Aqueous Rotavirus Vaccine Shows Promise for Ambient Shipping and Stability

A novel non-aqueous rotavirus vaccine formulation demonstrates significant thermostability and ease of administration, suitable for ambient shipping.

ViiV Healthcare's CAB ULA and RPV ULA Study for Virologically Suppressed HIV Patients

A study is underway to compare the efficacy and safety of CAB ULA and RPV ULA against their long-acting counterparts in HIV patients.

Progress on EBV Vaccine Development Critical for MS Prevention

Research indicates that Epstein-Barr virus (EBV) is a primary trigger for multiple sclerosis (MS), emphasizing the need for an effective vaccine.

FDA Grants AP Status for Clindamycin Phosphate ANDA064050 by Padagis US

The FDA has granted abbreviated approval (AP) status for the ANDA064050 application for Clindamycin Phosphate submitted by Padagis US.

FDA Accepts Supplemental Application for Malarone Pediatric

The FDA has accepted a supplemental application for Malarone Pediatric, containing atovaquone and proguanil hydrochloride.

FDA Approves ANDA for Valacyclovir Hydrochloride by Hetero Labs

The FDA has approved ANDA203047 for Valacyclovir Hydrochloride submitted by Hetero Labs.

Aurobindo Pharma's Cephalexin Receives FDA Approval

Aurobindo Pharma's ANDA213568 for Cephalexin has received FDA approval.

FDA Approves Linezolid in Sodium Chloride 0.9% for Hospira

The FDA has approved Linezolid in Sodium Chloride 0.9% in a plastic container under NDA206473.

FDA Approves Supplemental Applications for ZYVOX by Pfizer

The FDA has approved supplemental applications for ZYVOX (linezolid), indicating ongoing support for this antibiotic.

FDA Approves Supplement for Vancomycin Hydrochloride in Plastic Container

The FDA has approved a supplemental application for Vancomycin Hydrochloride in a plastic container by Baxter Healthcare.

Study on Intestinal TRM Cells and HIV-1 Persistence During ART Launched

A new study aims to characterize intestinal tissue-resident memory T cells in HIV-1 patients on ART, focusing on their role in viral persistence.

Analysis of Oral Nirmatrelvir/Ritonavir Utilization in Spain for COVID-19

The analysis highlights the potential benefits of increasing oral nirmatrelvir/ritonavir use in outpatient settings for high-risk COVID-19 patients in Spain.

Cefazolin Infusion Study Aims to Reduce Surgical Site Infections in Orthopedic Patients

A randomized control trial is evaluating continuous infusion versus intermittent bolus of cefazolin for preventing surgical site infections in orthopedic surgeries.

Study on Genetic Factors in Fungal Infection Susceptibility Launched

A new study aims to investigate immune disorders that increase susceptibility to fungal infections, specifically Candida.

FDA Approves First Generic of Xofluza for Influenza Treatment

The FDA has approved the first generic version of Xofluza, a single-dose treatment for influenza.

FDA Approves First Oral Carbapenem for Complicated UTIs

The FDA has approved the first oral carbapenem therapy specifically for complicated urinary tract infections.

FDA Approves CAPVAXIVE for At-Risk Children and Adolescents

The FDA has approved an expanded indication for CAPVAXIVE to include children and adolescents aged 2-17 at increased risk for pneumococcal disease.

Study on Host-Pathogen Interaction with Staphylococcus aureus Using Lymphoid Organoids

A study is being conducted to understand the interaction between Staphylococcus aureus and human cells using tonsil tissues.

Lupin's Doxycycline ANDA204234 Receives AP Status from FDA

Lupin's Abbreviated New Drug Application (ANDA204234) for Doxycycline has received an Approved Pending (AP) status from the FDA.

R-MVST Cells Show Promise for Treating Refractory Viral Infections

A clinical trial is assessing the safety and feasibility of R-MVST cells for patients with refractory viral infections caused by EBV, CMV, ADV, or BK virus.

OTAC Trial Evaluates Anti-COVID-19 Immunoglobulin in Outpatients

The OTAC trial is assessing the safety and efficacy of hIVIG versus placebo in outpatients with COVID-19.

Merck's ENFLONSIA Approved in EU for RSV Prevention in Infants

The European Commission has approved ENFLONSIA (clesrovimab) as the first RSV preventive option for infants in the EU.

FDA Approves Merck’s IDVYNSO for Virologically Suppressed HIV-1 Patients

Merck's IDVYNSO, a two-drug regimen, has been approved by the FDA for adults with virologically suppressed HIV-1.

mRNA-1083 Shows Durable Immune Response and Safety in Adults ≥50 Years

mRNA-1083 demonstrated durable antibody responses against influenza and SARS-CoV-2 for 6 months with a favorable safety profile.

Merck Receives FDA Approval for IDVYNSO, Expands Oncology Pipeline and Animal Health Sales

Merck has received U.S. FDA approval for IDVYNSO, a once-daily oral treatment for certain adults with virologically suppressed HIV-1.

Lilly expands infectious disease portfolio with three strategic acquisitions

Lilly has announced three acquisitions targeting viral and bacterial pathogens associated with significant health risks.

NextCOVE trial shows mRNA-1283 vaccine elicits higher nAb responses than mRNA-1273

The mRNA-1283 vaccine met non-inferiority criteria against mRNA-1273 and elicited higher neutralizing antibody responses.

Gilead and Merck Report Positive Phase 3 Results for Once-Weekly HIV Treatment Islatravir/Lenacapavir

Gilead and Merck announced positive topline results from two Phase 3 studies for Islatravir/Lenacapavir, a novel oral HIV treatment.

Pfizer's 25vPnC Vaccine Shows Strong Phase 2 Results, Advancing to Phase 3

Nanomaterial-based vaccines show promise for improved rotavirus protection

Nanomaterial-based vaccines could enhance rotavirus vaccine efficacy, particularly in malnourished populations.

GSK's AS03-adjuvanted H5N8 vaccine shows promising immunogenicity and safety in Phase 1/2 trial

The Phase 1/2 trial demonstrated that GSK's AS03-adjuvanted H5N8 vaccine met FDA immunogenicity criteria, with higher immune responses in younger adults.

COVAC-2 Vaccine Shows Safety and Immunogenicity as COVID-19 Booster in Phase 1 Trial

COVAC-2, a recombinant protein vaccine, demonstrated a favorable safety profile and strong immune responses as a booster in previously vaccinated adults.

Clinical Trial Evaluates PRS CK STORM for Cytokine Storm in Respiratory Infections

A clinical trial is assessing the safety and efficacy of PRS CK STORM in patients with cytokine storms from respiratory infections.

4CMenB and MenACWY-CRM Vaccines Co-Administered Safely in Adolescents

A phase 3b study demonstrated that co-administration of 4CMenB and MenACWY-CRM in adolescents is safe and immunogenic.

LIPUS and microbubbles enhance amphotericin B delivery for cryptococcal meningitis therapy

Low-intensity pulsed ultrasound combined with microbubbles significantly increased BBB permeability, enhancing amphotericin B delivery and efficacy against cryptococcal meningitis in a murine model.

FDA Accepts Supplement Application for Artesunate by Amivas

The FDA has accepted a supplemental application for Artesunate (NDA213036) submitted by Amivas.

FDA Grants AP Status for Doxycycline Hyclate Supplement by Impax Labs

The FDA has granted an Abbreviated New Drug Application (ANDA) approval status for a supplement of Doxycycline Hyclate submitted by Impax Labs.

South African HCPs Support Dual Prevention Pill but Highlight Key Challenges

Healthcare providers in South Africa support the Dual Prevention Pill (DPP) for HIV and pregnancy prevention but express concerns about daily dosing and side effects.