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Company

GSK

Pharmaceutical intelligence for GSK with 30 indexed intelligence signals across regulatory, clinical, competitive, and market developments.

Signals
19
Catalysts
11
Assets
17

Recent signals(19)

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 30, 2026

FDA Approves Supplemental Application for Brexafemme (Ibrexafungerp) by GlaxoSmithKline

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

RegulatoryJuly 29, 2026

FDA Accepts Supplement for Brexafemme (Ibrexafungerp) by GlaxoSmithKline

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

Upcoming catalysts

No catalysts indexed for this entity yet.

Regulatory activity(9)

RegulatoryJuly 30, 2026

FDA Approves Supplemental Application for Brexafemme (Ibrexafungerp) by GlaxoSmithKline

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

RegulatoryJuly 29, 2026

FDA Accepts Supplement for Brexafemme (Ibrexafungerp) by GlaxoSmithKline

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

RegulatoryJuly 29, 2026

FDA Accepts Supplemental Application for ZYBAN by GlaxoSmithKline

The FDA has accepted a supplemental application for ZYBAN, an established smoking cessation aid.

Clinical activity(6)

ClinicalJuly 22, 2026

GSK Initiates First-Time-in-Human Study of Remzistotug for Advanced Solid Tumors

GlaxoSmithKline has launched a first-time-in-human study of remzistotug targeting advanced solid tumors.

ClinicalJuly 19, 2026

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.

ClinicalJuly 11, 2026

GSK's Mo-Rez Evaluated in 1L Maintenance for HRd Ovarian Cancer in BEHOLD-Ovarian03 Trial

The BEHOLD-Ovarian03 trial is assessing the efficacy and safety of mocertatug rezetecan (Mo-Rez) in combination with bevacizumab versus bevacizumab alone in first-line maintenance treatment of HRd ovarian cancer.

Competitive activity(2)

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.

CompetitiveJune 17, 2026

Phase 3 Study of BLU-5937 Shows Promise for Refractory Chronic Cough

A Phase 3 study is underway to evaluate the efficacy and safety of BLU-5937 in adults with refractory chronic cough.

Assets

Belantamab →
bevacizumab →
BLU-5937 →
Brexafemme →
COVID-19 →
Depemokimab →
FDA →
GSK4425689A →
OJJAARA →
Paroxetine →
Phase →
Regulatory Approval →
Remzistotug →
Rotarix →
Trial Update →

Therapeutic areas

Antibiotic →
Antifungal →
Antimalarial →
Cardiac Safety →
Cardiology →
Cardiology · Cardiac Safety →
Chronic Cough →
COVID-19 →
HBV Co-Infection →
Hematology →
Hematology · Multiple Myeloma →
HIV →
IL-5 →
Immunology →

Indications

Infectious Disease →
Influenza →
Ovarian Cancer →

Newsletter

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RegulatoryJuly 29, 2026

FDA Accepts Supplemental Application for ZYBAN by GlaxoSmithKline

The FDA has accepted a supplemental application for ZYBAN, an established smoking cessation aid.

RegulatoryJuly 24, 2026

FDA Accepts Supplement for OJJAARA (Momelotinib Dihydrochloride) by GlaxoSmithKline

The FDA has accepted a supplemental application for OJJAARA, indicating progress in its regulatory pathway.

RegulatoryJuly 23, 2026

FDA Approves Supplemental Applications for ZYBAN by GlaxoSmithKline

The FDA has approved supplemental applications for ZYBAN (bupropion hydrochloride) submitted by GlaxoSmithKline.

ClinicalJuly 22, 2026

GSK Initiates First-Time-in-Human Study of Remzistotug for Advanced Solid Tumors

GlaxoSmithKline has launched a first-time-in-human study of remzistotug targeting advanced solid tumors.

ClinicalJuly 19, 2026

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.

StrategyJuly 12, 2026

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.

RegulatoryJuly 12, 2026

GSK's Bepirovirsen Study Evaluates Cardiac Conduction Impact in Healthy Volunteers

A study is underway to assess the impact of bepirovirsen on cardiac conduction, specifically the QT interval.

ClinicalJuly 11, 2026

GSK's Mo-Rez Evaluated in 1L Maintenance for HRd Ovarian Cancer in BEHOLD-Ovarian03 Trial

The BEHOLD-Ovarian03 trial is assessing the efficacy and safety of mocertatug rezetecan (Mo-Rez) in combination with bevacizumab versus bevacizumab alone in first-line maintenance treatment of HRd ovarian cancer.

StrategyJuly 4, 2026

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.

ClinicalJuly 2, 2026

GSK's Belantamab Mafodotin Study Targets Multiple Myeloma with Renal Impairment

A study is underway to evaluate the safety and pharmacokinetics of belantamab mafodotin in multiple myeloma patients with varying degrees of renal impairment.

RegulatoryJune 23, 2026

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.

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 Supplemental Application for Malarone Pediatric

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

ClinicalJune 17, 2026

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.

CompetitiveJune 17, 2026

Phase 3 Study of BLU-5937 Shows Promise for Refractory Chronic Cough

A Phase 3 study is underway to evaluate the efficacy and safety of BLU-5937 in adults with refractory chronic cough.

ClinicalJune 14, 2026

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.

RegulatoryJuly 24, 2026

FDA Accepts Supplement for OJJAARA (Momelotinib Dihydrochloride) by GlaxoSmithKline

The FDA has accepted a supplemental application for OJJAARA, indicating progress in its regulatory pathway.

RegulatoryJuly 23, 2026

FDA Approves Supplemental Applications for ZYBAN by GlaxoSmithKline

The FDA has approved supplemental applications for ZYBAN (bupropion hydrochloride) submitted by GlaxoSmithKline.

RegulatoryJuly 12, 2026

GSK's Bepirovirsen Study Evaluates Cardiac Conduction Impact in Healthy Volunteers

A study is underway to assess the impact of bepirovirsen on cardiac conduction, specifically the QT interval.

RegulatoryJune 23, 2026

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.

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 Supplemental Application for Malarone Pediatric

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

ClinicalJuly 2, 2026

GSK's Belantamab Mafodotin Study Targets Multiple Myeloma with Renal Impairment

A study is underway to evaluate the safety and pharmacokinetics of belantamab mafodotin in multiple myeloma patients with varying degrees of renal impairment.

ClinicalJune 17, 2026

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.

ClinicalJune 14, 2026

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.

UTEBZI →
ZYBAN →
Immunotherapy →
Infectious Disease →
Infectious Disease · Antimalarial →
Infectious Disease · COVID-19 →
Infectious Disease · HIV/HBV Co-Infection →
Infectious Disease · Influenza →
Infectious Disease · Vaccines →
Influenza →
Monoclonal Antibody →
Multiple Myeloma →
Neurology →
Oncology →
Oncology · Ovarian Cancer →
Ovarian Cancer →
Psychiatry · PTSD →
Respiratory →
Respiratory · Chronic Cough →
Small Molecule →
Smoking Cessation →
Vaccines →