NMPA Accepts GSK’s Arexvy Submission to Prevent Lower Respiratory Tract Disease in Adults

Shots: The Chinese NMPA has accepted the application of Arexvy RSV vaccine for the prevention of LRTD caused by respiratory syncytial virus (RSV) in adults aged ≥60yrs.; regulatory decision is expected by 2027 Submission was based on extensive clinical data, incl. results from the P-III trial assessing safety & immunogenicity of Arexvy in adults (≥60yrs.)…

ByRidhi RastogiFebruary 10, 2026

NEWS

GSK Reports the EC Approval of Nucala (Mepolizumab) for Chronic Obstructive Pulmonary Disease (COPD)

Shots: The EC has approved Nucala as an add-on maintenance treatment of adults with uncontrolled COPD characterised by raised blood eosinophils phenotype on a combination of an inhaled corticosteroid, a long-acting beta2-agonist (LABA), & a long-acting muscarinic antagonist Approval was based on the P-III (MATINEE) trial assessing Nucala (100mg, SC, Q4W; n=403) vs PBO (n=401)…

ByRidhi RastogiFebruary 6, 2026

NEWS

GSK’s Arexvy Receives the EC Approval to Prevent Respiratory Syncytial Virus (RSV) Disease

Shots: The EC has approved the Arexvy RSV vaccine for adults ≥18 yrs in Europe. While it was previously authorized only for adults ≥50 yrs at risk The adjuvanted RSV vaccine includes a stabilized form of a protein from the respiratory syncytial virus (RSV), called the prefusion F protein (RSVPreF3), combined with GSK’s AS01E adjuvant,…

ByDipanshu DixitJanuary 27, 2026

NEWS

GSK and Shionogi Restructure ViiV Healthcare Ownership as Pfizer Exits

Shots: GSK & Shionogi, together with Pfizer, have agreed to replace Pfizer’s 11.7% economic interest in ViiV Healthcare with an investment by Shionogi, reshaping the ownership structure of ViiV Healthcare As per the deal, ViiV Healthcare will issue new shares to Shionogi for $2.125B, cancel Pfizer’s stake, pay Pfizer $1.875B, & distribute a $0.25B special…

ByRidhi RastogiJanuary 21, 2026

INSIGHTS+

EMA Marketing Authorization of New Drugs in December 2025

Shots: Innovation in drug development continues to reshape patient care across dermatology, cardiology, immunology, oncology, respiratory medicine, and infectious diseases, as regulatory momentum in Europe remains strong toward the end of 2025. Recent EMA actions highlight how advanced biologics, precision small molecules, and next-generation vaccines are translating clinical breakthroughs into real-world impact. In December 2025, the EMA…

ByDipanshu DixitJanuary 20, 2026

INSIGHTS+

The US FDA New Drug Approvals in December 2025

Shots: Innovation peaked in December 2025, as the FDA delivered a wave of approvals spanning cardiometabolic disease, infectious disease, respiratory immunology, rare hematologic disorders, and acute cardiovascular and neurologic conditions highlighting both scientific breadth and clinical precision Seven notable therapies crossed the regulatory finish line, including LIB Therapeutics’ Lerochol for LDL lowering, Innoviva’s Nuzolvence for gonorrhea, GSK’s Exdensur for asthma with eosinophilic phenotype, Cytokinetics’ Myqorzo…

ByDipanshu DixitJanuary 13, 2026

NEWS

GSK Reports P-III (B-Well 1 & B-Well 2) Trial Data on Bepirovirsen for Chronic Hepatitis B

Shots: GSK has reported P-III (B-Well 1 & B-Well 2) trial results assessing bepirovirsen vs PBO in over 1,800 pts from 29 countries for the treatment of chronic hepatitis B (CHB) Both trials met the 1EP, with bepirovirsen delivering a statistically significant, clinically meaningful functional cure & showing superior cure rates vs SoC; Results were…

ByRidhi RastogiJanuary 8, 2026

NEWS

GSK Reports the MHLW Approval of Exdensur (Depemokimab) for Severe Asthma and CRSwNP

Shots: GSK’s Exdensur was approved for sev. or refractory bronchial asthma unresponsive to existing therapies & for CRSwNP in pts whose disease remains inadequately controlled with SoC, based on the P-III (SWIFT & ANCHOR) trials, respectively; filings under regulatory review in the EU & China SWIFT-1 (n=382) & SWIFT-2 (n=380) trials showed depemokimab reduced asthma…

ByRidhi RastogiJanuary 6, 2026

NEWS

GSK Reports the NMPA Approval of Nucala (Mepolizumab) for Chronic Obstructive Pulmonary Disease (COPD)

Shots: The Chinese NMPA has approved Nucala as an add-on maintenance treatment of adults with inadequately controlled COPD characterised by eosinophilic phenotype based on the P-III (MATINEE & METREX) trial; EMA filing is under review MATINEE assessed Nucala (100mg, SC, Q4W) vs PBO in COPD pts (n=804) with type 2 inflammation while METREX evaluated it…

ByRidhi RastogiJanuary 5, 2026

NEWS

Samsung Biologics Expands U.S. Manufacturing Footprint with Acquisition of Human Genome Sciences from GSK

Shots: Samsung Biologics’ US subsidiary entered a definitive agreement to acquire 100% of Human Genome Sciences from GSK, securing its first US based manufacturing site in Rockville, Maryland As per the deal terms, Samsung Biologics will acquire the Rockville assets for $280M, with closing expected by end of Q1’26, while retaining 500+ employees to ensure…

ByRidhi RastogiDecember 22, 2025

NMPA Accepts GSK’s Arexvy Submission to Prevent Lower Respiratory Tract Disease in Adults

GSK Reports the EC Approval of Nucala (Mepolizumab) for Chronic Obstructive Pulmonary Disease (COPD)

GSK’s Arexvy Receives the EC Approval to Prevent Respiratory Syncytial Virus (RSV) Disease

GSK and Shionogi Restructure ViiV Healthcare Ownership as Pfizer Exits

EMA Marketing Authorization of New Drugs in December 2025

The US FDA New Drug Approvals in December 2025

GSK Reports P-III (B-Well 1 & B-Well 2) Trial Data on Bepirovirsen for Chronic Hepatitis B

GSK Reports the MHLW Approval of Exdensur (Depemokimab) for Severe Asthma and CRSwNP

GSK Reports the NMPA Approval of Nucala (Mepolizumab) for Chronic Obstructive Pulmonary Disease (COPD)

Samsung Biologics Expands U.S. Manufacturing Footprint with Acquisition of Human Genome Sciences from GSK

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