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Therapeutic Area

Immunology

Therapeutic area intelligence for Immunology with 136 indexed intelligence signals across regulatory, clinical, competitive, and market developments.

Signals
135
Catalysts
1
Companies
41

Companies

AbbVie →
Accord Biopharma →
Alkem Labs →
Amgen →
AstraZeneca →
Astria Therapeutics →
Aurobindo Pharma →
Barr Pharmaceuticals →
Biocon Pharma →
Biogen →
BPI Labs →
Centocor Ortho Biotech →
Concord Biotech →
Eisai Co., Ltd. →
Eisai Korea Inc. →
Eli Lilly →
G-CSF →
GSK →
Hetero Labs →
Hikma →
Hikma Pharmaceuticals →
immunology therapeutics →
Macleods Pharmaceuticals →
Micro Labs →
Mylan Labs Ltd. →
Novartis →
Orient Pharma →
Pfizer →
Quell Therapeutics →
Regeneron →
RK Pharma →
Roche →
Sandoz →
Saptalis Pharmaceuticals →
Sciegen Pharmaceuticals →
Strides Pharma →
Sun Pharma →
UCB Biopharma →
Upsher Smith Labs →
Vera Therapeutics →
Zydus Pharmaceuticals →

Assets

ABCL575 →
Alexion →
Amneal →
Anifrolumab →
Apotex →
ARGENX →
Aurobindo →
Auson →
Azathioprine →
AZURITY →
Baricitinib →
BI →
Breckenridge →
CABA-201 →
Carnegie →
COSENTYX →
Deflazacort →
Depemokimab →
Dupixent →
Efgartigimod →
Eisai →
FDA →
fostamatinib →
Gazyva →
Genrix →
GSK4425689A →
HADLIMA →
Humira →
ILUMYA →
Immunology →
Immunostimulatory →
IMULDOSA →
Janssen →
Lebrikizumab →
Leflunomide →
litifilimab (BIIB059) →
Lupus Nephritis →
Methylprednisolone →
MK-1045 →
Mycophenolate Mofetil →
MYFORTIC →
Natural →
NIAID →
NMR →
Octapharma →
OLUMIANT →
Phase →
Plerixafor →
QEL-005 →
Remibrutinib →
RINVOQ →
Rituximab →
Safety →
SAPHNELO →
Shenzhen →
SILIQU (Brodalumab) →
SKYRIZI →
STELARA →
Tacrolimus →
Tofacitinib →
TRUTAKNA →
TYENNE →
TZIELD →
UCB →
ustekinumab →
Viatris →
VYVGART →
WEZLANA →
Xeljanz →
YAOPHARMA →

Recent signals(135)

RegulatoryAugust 6, 2026

FDA Accepts Supplement Application for SILIQ (Brodalumab)

The FDA has accepted a supplemental application for SILIQ (Brodalumab) submitted by Valeant Luxembourg.

RegulatoryAugust 5, 2026

FDA Approval Letter for Methylprednisolone Supplement

The FDA has issued an approval letter for a supplement to the ANDA040183 application for Methylprednisolone.

RegulatoryAugust 5, 2026

FDA Approves Supplemental Applications for CellCept (Mycophenolate Mofetil)

The FDA has approved supplemental applications for CellCept, indicating ongoing support for its use.

StrategyAugust 5, 2026

FDA Grants Approval for Tacrolimus ANDA203740 by Alkem Labs

The FDA has granted approval for the ANDA203740 application for Tacrolimus submitted by Alkem Labs.

RegulatoryAugust 2, 2026

FDA Approval Process Update for Mycophenolate Sodium by Yichang Humanwell

The FDA has accepted the application ANDA214376 for Mycophenolate Sodium submitted by Yichang Humanwell, with a standard review priority.

ClinicalAugust 2, 2026

BI 3000202 Tolerability Study in Type 1 Interferonopathies Initiated

A clinical trial is underway to assess the tolerability of BI 3000202 in adults with selected type 1 interferonopathies.

RegulatoryAugust 2, 2026

FDA Approves Supplemental Application for MYFORTIC by Novartis

The FDA has approved a supplemental application for MYFORTIC, an immunosuppressant used in renal transplantation.

RegulatoryAugust 2, 2026

FDA Acceptance of Supplement Application for MYHIBBIN by AZURITY

The FDA has accepted a supplemental application for MYHIBBIN (NDA216482) from AZURITY.

RegulatoryAugust 2, 2026

FDA Approves Supplement for CellCept (Mycophenolate Mofetil) by Roche

The FDA has approved a supplemental application for CellCept, a drug containing mycophenolate mofetil hydrochloride, submitted by Roche.

RegulatoryAugust 2, 2026

FDA Approval Status Update for Mycophenolate Mofetil by Hikma

The FDA has issued an approval status update for Hikma's ANDA065410 concerning Mycophenolate Mofetil.

StrategyAugust 2, 2026

Aurobindo Pharma's Mycophenolate Mofetil ANDA218227 Receives AP Status

Aurobindo Pharma's ANDA218227 for Mycophenolate Mofetil has received an Abbreviated Approval (AP) status from the FDA.

StrategyAugust 2, 2026

FDA Approval Update for Mycophenolate Mofetil by Hikma

Hikma has received an approval status for their ANDA submission for Mycophenolate Mofetil.

RegulatoryAugust 2, 2026

FDA Approval Status Update for Mycophenolate Sodium by RK Pharma

RK Pharma's application for Mycophenolate Sodium has received an approval status update from the FDA.

StrategyAugust 2, 2026

Aurobindo Pharma's Mycophenolate Mofetil ANDA217828 Receives AP Status

Aurobindo Pharma's application for Mycophenolate Mofetil (ANDA217828) has received Abbreviated Approval (AP) status from the FDA.

RegulatoryAugust 2, 2026

FDA Grants AP Status for Mycophenolate Mofetil ANDA214079 by WUXI

The FDA has granted an Abbreviated Approval (AP) for the ANDA214079 application for Mycophenolate Mofetil submitted by WUXI.

StrategyAugust 2, 2026

FDA Grants AP Status for Mycophenolate Sodium ANDA217031 by Biocon Pharma

The FDA has granted an Abbreviated Approval (AP) for the ANDA217031 application for Mycophenolate Sodium submitted by Biocon Pharma.

RegulatoryAugust 2, 2026

Aurobindo Pharma submits supplemental application for Mycophenolate Mofetil

Aurobindo Pharma has submitted a supplemental application for Mycophenolate Mofetil under ANDA217937.

StrategyAugust 1, 2026

Mylan Labs receives AP status for Mycophenolate Mofetil Hydrochloride ANDA203859

Mylan Labs Ltd. has received an Abbreviated Approval (AP) for their ANDA203859 application for Mycophenolate Mofetil Hydrochloride.

StrategyAugust 1, 2026

FDA Approves ANDA for Mycophenolate Mofetil by Hetero Labs

The FDA has approved ANDA208119 for Mycophenolate Mofetil submitted by Hetero Labs.

StrategyAugust 1, 2026

FDA Approves ANDA207022 for Mycophenolate Mofetil by Hetero Labs

The FDA has approved ANDA207022 for Mycophenolate Mofetil submitted by Hetero Labs.

RegulatoryAugust 1, 2026

FDA Approves Mycophenolate Mofetil Hydrochloride Supplement Application

The FDA has approved the supplemental application for Mycophenolate Mofetil Hydrochloride submitted by BPI Labs.

ClinicalAugust 1, 2026

Safety and Tolerability Study of Dapirolizumab Pegol in Systemic Lupus Erythematosus

A study is underway to evaluate the long-term safety and tolerability of dapirolizumab pegol in patients with systemic lupus erythematosus.

StrategyAugust 1, 2026

Aurobindo Pharma's Mycophenolate Sodium ANDA Submission Receives AP Status

Aurobindo Pharma Ltd. has received Abbreviated Approval (AP) for its ANDA218603 submission for Mycophenolate Sodium.

CompetitiveAugust 1, 2026

First-in-Human Trial for GSK4425689A Monoclonal Antibody Initiated

A first-in-human dose-escalation study for GSK4425689A is underway, focusing on safety and pharmacokinetics.

RegulatoryJuly 31, 2026

FDA Accepts Supplement Application for HADLIMA by Samsung Bioepis

The FDA has accepted the supplemental application for HADLIMA (BLA761059), a biosimilar to adalimumab.

ClinicalJuly 30, 2026

Remibrutinib Shows Promise in Peanut Allergy Trial

A study is underway to evaluate remibrutinib's safety and efficacy in adults with peanut allergies, focusing on dose tolerance.

RegulatoryJuly 29, 2026

FDA Accepts Application for SAPHNELO (Anifrolimab-FNIA) by AstraZeneca

The FDA has accepted the Biologics License Application for SAPHNELO (anifrolimab-FNIA) submitted by AstraZeneca.

ClinicalJuly 29, 2026

Phase I Trial of GR2301 Injection by Genrix Initiated in Healthy Adults

Genrix has initiated Phase I clinical trial for GR2301 injection to assess its safety and pharmacokinetics in healthy adults.

RegulatoryJuly 28, 2026

FDA grants supplemental application approval for Dupixent (BLA761055)

The FDA has approved the supplemental application for Dupixent (BLA761055) submitted by Regeneron Pharmaceuticals.

RegulatoryJuly 28, 2026

FDA Grants Priority Review for TZIELD (Teplizumab) Supplement

The FDA has granted priority review status for the supplemental Biologics License Application (BLA) for TZIELD (teplizumab) submitted by Provention Bio.

RegulatoryJuly 28, 2026

FDA Submission Update for COSENTYX (Secukinumab) by Novartis

Novartis has submitted a supplemental application for COSENTYX (Secukinumab) under BLA761349, currently under standard review.

RegulatoryJuly 27, 2026

FDA Grants Priority Review for Cosentyx Supplement Application

The FDA has granted priority review for the supplemental biologics application for Cosentyx (secukinumab) submitted by Novartis.

ClinicalJuly 27, 2026

Shenzhen Geno-Immune initiates trial on cfMSCs for immune-related disorders

A clinical trial is evaluating the safety and efficacy of clonal fetal mesenchymal stem cells for immune-related disorders.

RegulatoryJuly 27, 2026

FDA Accepts Supplement Application for STELARA by Janssen Biotech

The FDA has accepted the supplemental biologics application (BLA761044) for STELARA, indicating a potential expansion of its use.

RegulatoryJuly 27, 2026

FDA Accepts Supplement for STELARA (Ustekinumab) by Centocor Ortho Biotech

The FDA has accepted a supplemental application for STELARA (ustekinumab) from Centocor Ortho Biotech.

ClinicalJuly 26, 2026

Efgartigimod Trial Initiated for IgG4-Related Disease Treatment

A clinical trial has been launched to evaluate the efficacy of efgartigimod in treating IgG4-related disease.

RegulatoryJuly 26, 2026

FDA grants AP status to Methylprednisolone ANDA204072 from Tianjin Tianyao

The FDA has granted approval status (AP) for the ANDA204072 application for Methylprednisolone submitted by Tianjin Tianyao.

RegulatoryJuly 26, 2026

FDA Updates Boxed Warnings for JAK Inhibitors Due to Serious Risks

The FDA mandates new warnings for Xeljanz, Olumiant, and Rinvoq regarding increased risks of serious heart events, cancer, blood clots, and death.

RegulatoryJuly 25, 2026

FDA Accepts Supplement for RINVOQ (Upadacitinib) by AbbVie

The FDA has accepted a supplemental application for RINVOQ (upadacitinib), indicating ongoing development and potential label expansion.

ClinicalJuly 24, 2026

Study on Tripterygium Glycosides Tablets Reveals Anti-Inflammatory Potential

Tripterygium Glycosides Tablets (TGTs) are recognized for their anti-inflammatory effects, though their bioactive components are not fully characterized.

RegulatoryJuly 24, 2026

FDA Approval Update for Azathioprine Supplement by Rising

The FDA has granted an Abbreviated New Drug Application (ANDA) approval for a supplement of Azathioprine by Rising.

RegulatoryJuly 23, 2026

FDA Accepts Supplement for ILUMYA (Tildrakizumab) by Sun Pharma

The FDA has accepted a supplemental biologics application for ILUMYA (tildrakizumab) from Sun Pharma.

CompetitiveJuly 23, 2026

Aurobindo Pharma's ANDA for Tofacitinib Citrate Receives AP Status

Aurobindo Pharma's ANDA for Tofacitinib Citrate has received an Abbreviated Approval (AP) status from the FDA.

StrategyJuly 23, 2026

FDA Approves ANDA for Tofacitinib Citrate by Sun Pharma

The FDA has granted approval for ANDA218407, a generic version of Tofacitinib Citrate submitted by Sun Pharma.

StrategyJuly 23, 2026

Apotex submits ANDA for Tofacitinib Citrate, FDA review ongoing

Apotex has submitted an Abbreviated New Drug Application (ANDA) for Tofacitinib Citrate, currently under FDA review.

StrategyJuly 23, 2026

FDA Approves Breckenridge's Tofacitinib Citrate Application

The FDA has approved Breckenridge's application for Tofacitinib Citrate under ANDA209633.

RegulatoryJuly 22, 2026

FDA Grants Approval for Tofacitinib Citrate (ANDA217298)

The FDA has granted approval for Tofacitinib Citrate under ANDA217298, submitted by MSN.

RegulatoryJuly 22, 2026

FDA Approval Letter for Tofacitinib Citrate by Micro Labs

The FDA has issued an approval letter for ANDA209738 for Tofacitinib Citrate submitted by Micro Labs.

RegulatoryJuly 22, 2026

FDA Grants Approval for Tofacitinib Citrate ANDA220137

The FDA has granted approval for the ANDA of Tofacitinib Citrate submitted by Somerset Therap LLC.

RegulatoryJuly 22, 2026

FDA Accepts Supplement Application for Leflunomide by Barr

The FDA has accepted a supplemental application for Leflunomide submitted by Barr.

StrategyJuly 22, 2026

FDA Grants Approval for Mycophenolate Mofetil ANDA218566 by Concord Biotech

The FDA has granted approval for the ANDA218566 application for Mycophenolate Mofetil submitted by Concord Biotech.

RegulatoryJuly 22, 2026

FDA Approves Supplement for ULTOMIRIS (Ravulizumab-Cwvz)

The FDA has approved a supplemental application for ULTOMIRIS, indicating a significant regulatory milestone for Alexion Pharmaceuticals.

CompetitiveJuly 22, 2026

FDA Grants AP Status for Zydus' Methylprednisolone ANDA206751

The FDA has granted an Abbreviated New Drug Application (ANDA) approval status for Zydus Pharmaceuticals' methylprednisolone.

RegulatoryJuly 21, 2026

FDA Accepts Supplement Application for Sandimmune by Novartis

The FDA has accepted a supplemental application for Sandimmune (cyclosporine) from Novartis.

RegulatoryJuly 21, 2026

FDA Grants Approval for Deflazacort ANDA220709 by Carnegie

The FDA has granted approval for the ANDA220709 application for Deflazacort submitted by Carnegie.

RegulatoryJuly 21, 2026

FDA Accepts Supplement for TREMFYA (Guselkumab) by Janssen Biotech

The FDA has accepted a supplemental application for TREMFYA (guselkumab) from Janssen Biotech.

RegulatoryJuly 20, 2026

FDA Accepts Supplement Application for TOFIDENCE (Tocilizumab-Bavi)

The FDA has accepted the supplemental application for BLA761354, which includes Tocilizumab-Bavi as an active ingredient.

RegulatoryJuly 20, 2026

FDA Approves Supplemental Application for TYENNE (Tocilizumab-AAZG)

The FDA has approved a supplemental application for TYENNE, a formulation of Tocilizumab-AAZG, submitted by Fresenius Kabi USA.

RegulatoryJuly 19, 2026

FDA Approves Supplement for TYENNE (Tocilizumab-AAZG) by Fresenius Kabi

The FDA has approved a supplemental application for TYENNE, a formulation of Tocilizumab-AAZG.

RegulatoryJuly 18, 2026

FDA Accepts Supplementary Application for STELARA by Centocor Ortho Biotech

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

RegulatoryJuly 18, 2026

FDA Accepts BLA for IMMGOLIS (GOLIMUMAB-SLDI) by Accord Biopharma

The FDA has accepted the Biologics License Application (BLA) for IMMGOLIS, a formulation of GOLIMUMAB-SLDI.

RegulatoryJuly 15, 2026

FDA Accepts Supplement Application for WEZLANA (Ustekinumab-Auub) by Amgen

The FDA has accepted the supplemental application for WEZLANA, an IL-12/23 inhibitor.

ClinicalJuly 15, 2026

Biogen's Litifilimab (BIIB059) Study Targets Active Cutaneous Lupus Erythematosus

Biogen is conducting a 2-part clinical trial to evaluate the efficacy and safety of litifilimab in patients with active cutaneous lupus erythematosus.

StrategyJuly 14, 2026

Human factors study validates Bmab 1200 autoinjector for ustekinumab delivery

The Bmab 1200 autoinjector showed high usability and safety in a human factors validation study with 100% successful unaided injections.

RegulatoryJuly 14, 2026

FDA Grants Priority Review for VYVGART HYTRULO Supplement by ARGENX

The FDA has granted priority review status for the supplemental application of VYVGART HYTRULO, which contains Efgartigimod Alfa and Hyaluronidase-QVFC.

RegulatoryJuly 14, 2026

FDA Grants Priority Review for VYVGART Supplement Application

The FDA has granted priority review for the supplemental application of VYVGART (efgartigimod alfa) by Argenx BV.

RegulatoryJuly 12, 2026

FDA Grants Priority Review for TRUTAKNA (BLA761486) by Vera Therapeutics

The FDA has granted priority review status for TRUTAKNA, an application submitted by Vera Therapeutics.

RegulatoryJuly 12, 2026

FDA Grants Approval for Mycophenolate Sodium by Yichang Humanwell

The FDA has granted approval for Mycophenolate Sodium under application ANDA214376 submitted by Yichang Humanwell.

ClinicalJuly 12, 2026

Study on Genetic Factors in Severe Combined Immunodeficiency (SCID)

A study is being conducted to investigate hereditary factors in severe combined immunodeficiency (SCID), focusing on patients with specific immunodeficiency profiles.

ClinicalJuly 11, 2026

UCB's Dapirolizumab Pegol Shows Promise in Systemic Lupus Erythematosus Study

A study is underway to evaluate the efficacy and safety of dapirolizumab pegol as an add-on treatment for moderately to severely active systemic lupus erythematosus.

RegulatoryJuly 11, 2026

FDA Accepts Supplement Application for HADLIMA (Adalimumab Biosimilar)

The FDA has accepted the supplemental application for HADLIMA, a biosimilar to adalimumab.

ClinicalJuly 10, 2026

Regeneron initiates dose escalation study of bispecific antibodies for Lupus Nephritis

Regeneron Pharmaceuticals is conducting a dose escalation study of bispecific antibodies in adult participants with Lupus Nephritis.

RegulatoryJuly 10, 2026

FDA Approves Supplemental Application for RINVOQ LQ by AbbVie

The FDA has approved a supplemental application for RINVOQ LQ (upadacitinib) submitted by AbbVie.

CompetitiveJuly 10, 2026

Cabaletta Bio initiates RESET-Myositis trial for CABA-201 in inflammatory myopathy

Cabaletta Bio is conducting an open-label study to assess the safety and efficacy of CABA-201 in patients with active idiopathic inflammatory myopathy.

RegulatoryJuly 9, 2026

FDA Accepts Supplemental Application for XELJANZ (Tofacitinib Citrate)

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

RegulatoryJuly 9, 2026

FDA Accepts Supplement Application for Soliris (Eculizumab) by Alexion Pharmaceuticals

The FDA has accepted a supplemental application for Soliris, an eculizumab-based therapy.

RegulatoryJuly 9, 2026

FDA Approves Supplemental Application for XELJANZ XR by Pfizer

The FDA has approved a supplemental application for XELJANZ XR, JAK inhibitor developed by Pfizer.

ClinicalJuly 9, 2026

AstraZeneca's Anifrolumab Study for Systemic Lupus Erythematosus Underway

AstraZeneca is conducting a study to evaluate the pharmacokinetics, pharmacodynamics, and safety of anifrolumab in patients with systemic lupus erythematosus.

ClinicalJuly 9, 2026

Natural History Study of Trisomy 8-Associated Autoinflammatory Disease Launched

A natural history study has been initiated to characterize trisomy 8 mosaicism and related autoinflammatory disorders, focusing on clinical and immunologic profiles.

RegulatoryJuly 9, 2026

FDA Accepts Supplement for OLUMIANT (Baricitinib) by Eli Lilly

The FDA has accepted a supplemental application for OLUMIANT (Baricitinib) from Eli Lilly.

RegulatoryJuly 8, 2026

FDA Acceptance of Supplement for BLA761340 by Samsung Bioepis

The FDA has accepted the supplemental biologics license application for EPYSQLI (eculizumab-aagh) from Samsung Bioepis.

RegulatoryJuly 8, 2026

FDA Accepts Supplement for BLA761333 by Amgen for Eculizumab-AEEB

The FDA has accepted the supplemental Biologics License Application (BLA) for BLA761333, which contains the active ingredient Eculizumab-AEEB.

RegulatoryJuly 8, 2026

FDA Grants Abbreviated Approval for Tofacitinib Citrate by Sciegen Pharmaceuticals

The FDA has granted abbreviated approval for Tofacitinib Citrate under application ANDA220972 submitted by Sciegen Pharmaceuticals.

RegulatoryJuly 8, 2026

FDA Accepts Supplement Application for Eculizumab-AAGH by Samsung Bioepis

The FDA has accepted the supplemental application for BLA761340, a biosimilar of eculizumab.

ClinicalJuly 8, 2026

Eisai Initiates Post-Marketing Study of Jyseleca in Korea to Assess Safety and Efficacy

Eisai Korea Inc. is conducting a post-marketing study to evaluate the safety and efficacy of Jyseleca (Filgotinib Maleate) in Korean participants.

ClinicalJuly 6, 2026

NIAID Launches Study on Inflammatory Disorders with Long-Term Follow-Up

The NIAID is conducting a study to evaluate and follow up on patients with various inflammatory disorders, including infections and immune dysfunctions.

RegulatoryJuly 6, 2026

FDA Accepts BLA for Anifrolumab by AstraZeneca

The FDA has accepted the Biologics License Application for Anifrolumab, a treatment for systemic lupus erythematosus.

RegulatoryJuly 5, 2026

FDA Accepts Supplemental Application for Dupixent (Dupilumab)

The FDA has accepted a supplemental application for Dupixent (dupilumab) from Regeneron Pharmaceuticals.

RegulatoryJuly 4, 2026

FDA Approves Supplemental Application for Cosentyx (Secukinumab)

The FDA has approved a supplemental application for Cosentyx (Secukinumab) submitted by Novartis.

RegulatoryJuly 4, 2026

FDA Accepts Supplement Application for STELARA by Janssen Biotech

The FDA has accepted a supplemental application for STELARA (ustekinumab) from Janssen Biotech.

ClinicalJuly 4, 2026

Eisai's E6742 Shows Promise in Systemic Lupus Erythematosus Study

E6742 is being evaluated for efficacy in systemic lupus erythematosus compared to placebo, with results expected at Week 24.

RegulatoryJuly 3, 2026

FDA Accepts Supplement for SKYRIZI (Risankizumab) by AbbVie

The FDA has accepted a supplemental application for SKYRIZI (Risankizumab) from AbbVie.

ClinicalJuly 1, 2026

Rituximab and Low-Dose Mycophenolate Mofetil Trial for Pediatric Lupus Nephritis

A clinical trial is underway to evaluate the efficacy and safety of rituximab combined with low-dose mycophenolate mofetil for treating proliferative lupus nephritis in children.

RegulatoryJuly 1, 2026

FDA Grants AP Status for Methylprednisolone Sodium Succinate by Amneal

The FDA has granted Abbreviated Approval (AP) status for Methylprednisolone Sodium Succinate submitted by Amneal.

ClinicalJuly 1, 2026

Quell Therapeutics Initiates Phase 1/2 Trial for QEL-005 in Autoimmune Diseases

Quell Therapeutics is conducting Phase 1/2 trial of QEL-005, an autologous CAR-T therapy targeting CD19, in patients with dcSSc and D2TRA.

CompetitiveJuly 1, 2026

Phase 3 Trial of C1 Esterase Inhibitor for Acute Hereditary Angioedema by Octapharma

Octapharma is conducting a phase 3 trial of C1 esterase inhibitor concentrate for treating acute hereditary angioedema.

CompetitiveJuly 1, 2026

Phase 3 Trial of Navenibart for Hereditary Angioedema Initiated by Astria Therapeutics

Astria Therapeutics has initiated Phase 3 trial for navenibart in patients with hereditary angioedema.

ClinicalJune 30, 2026

Phase I/II Trial of Lentiviral Gene Transfer for XSCID in Children Over Two Years

A Phase I/II trial is underway to evaluate a lentiviral gene transfer treatment for X-linked severe combined immunodeficiency (XSCID) in children older than two years.

StrategyJune 30, 2026

FDA Accepts ANDA for Tofacitinib Citrate by Aurobindo Pharma

The FDA has accepted the Abbreviated New Drug Application (ANDA) for Tofacitinib Citrate submitted by Aurobindo Pharma.

ClinicalJune 28, 2026

Fostamatinib Trial for Lung Transplant Patients with Donor-Specific Antibodies

A trial is underway to evaluate the safety and tolerability of fostamatinib in lung transplant patients with donor-specific antibodies.

ClinicalJune 28, 2026

Plerixafor vs G-CSF Trial for WHIM Syndrome: A Comparative Study

A clinical trial is underway to compare the efficacy of plerixafor against G-CSF in treating infections in patients with WHIM syndrome.

ClinicalJune 26, 2026

Study on Fibroblast-Derived Cell Lines for Gene Therapy in Immune Disorders

NIAID is conducting a study to collect skin cell samples from patients with immune disorders to explore personalized gene therapy.

ClinicalJune 25, 2026

Immunostimulatory adjuvant reverses vaccine response decline in aged models

An immunostimulatory adjuvant effectively reversed reduced antibody production in aged mice and nonhuman primates.

ClinicalJune 24, 2026

Merck initiates trial for MK-1045 in lupus and rheumatoid arthritis patients

Merck Sharp & Dohme LLC is conducting a clinical study to evaluate the safety and tolerability of MK-1045 in patients with lupus and rheumatoid arthritis.

RegulatoryJune 22, 2026

FDA Acceptance of Tofacitinib Citrate Application by Zydus Pharms

The FDA has accepted the application for Tofacitinib Citrate submitted by Zydus Pharms.

ClinicalJune 22, 2026

AbCellera initiates Phase 1 trial for ABCL575 assessing safety in healthy participants

AbCellera Biologics has launched Phase 1 trial to evaluate the safety and tolerability of ABCL575 in healthy volunteers.

StrategyJune 22, 2026

FDA Grants Approval for Tofacitinib Citrate ANDA219395

The FDA has granted approval for ANDA219395, a generic formulation of Tofacitinib Citrate by SPECGX LLC.

StrategyJune 22, 2026

FDA Grants Approval for Tofacitinib Citrate ANDA219530 by Macleods Pharmaceuticals

The FDA has granted approval for ANDA219530, a generic version of Tofacitinib Citrate, submitted by Macleods Pharmaceuticals.

CompetitiveJune 22, 2026

Apotex submits ANDA for Tofacitinib Citrate

Apotex has submitted an Abbreviated New Drug Application (ANDA) for Tofacitinib Citrate, currently under standard review.

StrategyJune 22, 2026

FDA Approves ANDA for Tofacitinib Citrate by MSN

The FDA has approved the ANDA217299 application for Tofacitinib Citrate submitted by MSN.

ClinicalJune 22, 2026

Viatris Initiates Trial for Cenerimod in Active Lupus Nephritis

A clinical trial is underway to assess the efficacy and safety of cenerimod for treating active lupus nephritis in adults.

RegulatoryJune 21, 2026

FDA Accepts Supplement Application for Depemokimab by GlaxoSmithKline

The FDA has accepted the supplemental application for BLA761458, a biologic from GlaxoSmithKline.

RegulatoryJune 21, 2026

FDA Accepts ANDA for Tofacitinib Citrate by YAOPHARMA

The FDA has accepted the Abbreviated New Drug Application (ANDA) for Tofacitinib Citrate submitted by YAOPHARMA.

StrategyJune 21, 2026

FDA Grants Approval for Tofacitinib Citrate ANDA219830 by Orient Pharma

The FDA has granted approval for the ANDA219830 application for Tofacitinib Citrate submitted by Orient Pharma.

StrategyJune 21, 2026

FDA Approves ANDA for Tofacitinib Citrate by Auson

The FDA has approved the ANDA219370 for Tofacitinib Citrate submitted by Auson.

StrategyJune 21, 2026

FDA Grants Approval for Tofacitinib Citrate ANDA218821 by Concord Biotech

The FDA has granted approval for ANDA218821, a generic version of tofacitinib citrate submitted by Concord Biotech.

ClinicalJune 21, 2026

Baricitinib Trial for Job Syndrome Patients with Lupus-Like Disease or Atopic Dermatitis

A clinical trial is evaluating the safety and tolerability of baricitinib in patients with Job syndrome who also have lupus-like disease or atopic dermatitis.

StrategyJune 21, 2026

FDA Grants Approval for Tofacitinib Citrate ANDA218900 by Saptalis Pharmaceuticals

The FDA has granted approval for ANDA218900, a generic version of Tofacitinib Citrate, submitted by Saptalis Pharmaceuticals.

RegulatoryJune 21, 2026

FDA Accepts Supplement for Lebrikizumab by Eli Lilly

The FDA has accepted the supplemental biologics application for Lebrikizumab (BLA761306) from Eli Lilly.

StrategyJune 21, 2026

NMR Reveals Key Excipient Interactions Affecting mAb Viscosity in Formulations

NMR spectroscopy identifies arginine and lysine as effective excipients that reduce mAb viscosity, while proline and glycine promote clustering.

ClinicalJune 21, 2026

Eli Lilly's Remternetug Study in Healthy Chinese Participants Initiated

Eli Lilly is conducting a safety and tolerability study of remternetug in healthy Chinese participants, lasting up to 25 weeks.

RegulatoryJune 20, 2026

FDA Accepts Supplement Application for IMULDOSA by Accord Biopharma

The FDA has accepted the supplemental application for IMULDOSA (USTEKINUMAB-SRLF) from Accord Biopharma.

RegulatoryJune 20, 2026

FDA Grants Priority Review for TZIELD (Teplizumab) Supplement

The FDA has granted priority review for the supplemental application of TZIELD (Teplizumab) by Provention Bio.

ClinicalJune 20, 2026

Study on Genetic Disorders of the Immune System Launched by NIAID

NIAID is conducting a study to evaluate individuals with specific immune system disorders, involving extensive genetic and medical assessments.

RegulatoryJune 19, 2026

FDA Grants AP Status for Methylprednisolone ANDA210985 by Ingenus Pharms

The FDA has granted an Abbreviated New Drug Application (ANDA) approval status for methylprednisolone submitted by Ingenus Pharms.

CompetitiveJune 19, 2026

Hikma's Methylprednisolone Sodium Succinate ANDA202691 Receives AP Status

Hikma's application for Methylprednisolone Sodium Succinate (ANDA202691) has received an Abbreviated Approval (AP) status from the FDA.

RegulatoryJune 18, 2026

FDA Accepts Supplement Application for SKYRIZI (Risankizumab)

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

RegulatoryJune 18, 2026

FDA Accepts Supplement Application for SKYRIZI (Risankizumab) by AbbVie

The FDA has accepted a supplemental application for SKYRIZI (Risankizumab) from AbbVie.

RegulatoryJune 18, 2026

Hikma's Methylprednisolone Sodium Succinate ANDA203125 Receives AP Status

The FDA has granted an Abbreviated New Drug Application (ANDA) approval status of 'AP' for Hikma's Methylprednisolone Sodium Succinate.

RegulatoryJune 17, 2026

FDA Accepts Roche's Gazyva for Systemic Lupus Erythematosus Treatment

The FDA has accepted Roche's sBLA for Gazyva/Gazyvaro, based on phase III ALLEGORY data showing significant efficacy in SLE.

RegulatoryJune 16, 2026

Saphnelo Self-Administration Approved in the US for SLE Treatment

AstraZeneca's Saphnelo has received FDA approval for self-administration via a new autoinjector, enhancing patient convenience.

RegulatoryJune 8, 2026

FDA Approval Process Update for Mycophenolate Mofetil by Strides Pharma

The FDA has an active application (ANDA212634) for Mycophenolate Mofetil submitted by Strides Pharma, currently under standard review.

RegulatoryJune 8, 2026

FDA Approves Supplement for Methylprednisolone Acetate by Sandoz

The FDA has approved a supplemental application for Methylprednisolone Acetate submitted by Sandoz.

RegulatoryJune 8, 2026

Sandoz's Methylprednisolone ANDA040194 Receives AP Status from FDA

The FDA has granted an Abbreviated New Drug Application (ANDA) approval status to Sandoz for methylprednisolone.

RegulatoryJune 6, 2026

FDA Approves Deflazacort Supplement Application by Upsher Smith Labs

The FDA has approved a supplemental application for Deflazacort submitted by Upsher Smith Labs.

Upcoming catalysts(1)

PDUFA Date

Regeneron — Dupixent

COPD label expansion would open multi-billion TAM beyond atopic indications.

June 27, 2026 · NDA/BLA

Indications

Autoimmune Disease →
Autoimmune Diseases →
Autoimmune Disorders →
Autoinflammatory Disorders →
Chronic obstructive pulmonary disease →
Genetic Disorders →
IgG4-Related Disease →
Inflammatory Disorders →
Lupus and Rheumatoid Arthritis →
Psoriasis and Autoimmune Diseases →
Rare Disease →
Rheumatoid Arthritis →
Type 1 Diabetes →

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