EMA Marketing Authorization of New Drugs in February 2026

Shots: The European Commission approved multiple innovative therapies across vaccines, oncology, cardiology, immunology, and rare diseases, including products from Moderna, Hansoh Pharmaceutical, Cytokinetics, ImmunityBio, and GSK The Committee for Medicinal Products for Human Use also issued positive opinions for late-stage assets from Ipsen, X4 Pharmaceuticals, Novartis, and Moderna, alongside additional recommendations for therapies targeting chronic spontaneous urticaria, WHIM syndrome, pediatric…

ByDipanshu DixitMarch 17, 2026

NEWS

GSK Receives the US FDA Approval of Arexvy to Prevent Respiratory Syncytial Virus (RSV) Disease

Shots: The US FDA has approved Arexvy RSV vaccine for adults (18-49yrs.) at increased risk for lower respiratory tract disease, expanding its use beyond those aged ≥50yrs. Approval was based on P-IIIb trial (n=1458) assessing immune response & safety of Arexvy RSV vaccine in individuals (18-49yrs.; n=426) compared to adults (≥60yrs.; n=429); an additional cohort (18-49yrs.; n=603) was…

ByRidhi RastogiMarch 13, 2026

NEWS

GSK Licenses Linerixibat’s Global Rights to Alfasigma in ~$690M Deal

Shots: GSK has granted Alfasigma worldwide exclusive rights to develop, manufacture & commercialise linerixibat for cholestatic pruritus in primary biliary cholangitis As per the deal, GSK will receive $300M upfront, $100M upon FDA approval (based on PDUFA date of Mar 24, 2026), $20M upon EU & UK approval, & ~$270M in sales milestones, along with…

ByRidhi RastogiMarch 9, 2026

NEWS

GSK Reports the MHLW’s NDA Acceptance for Bepirovirsen to Treat Chronic Hepatitis B

Shots: The Japanese MHLW has accepted the NDA of bepirovirsen, an antisense oligonucleotide, for the treatment of adults with chronic hepatitis B (CHB) NDA was supported by the P-III (B-Well 1 & B-Well 2) trial results assessing bepirovirsen vs PBO in pts from 29 countries for the treatment of CHB Trials showed statistically significant &…

ByRidhi RastogiFebruary 27, 2026

NEWS

GSK Reports the NMPA’s NDA Acceptance with Priority Review of Linerixibat for Cholestatic Pruritus

Shots: The Chinese NMPA has accepted NDA & granted priority review to linerixibat, an IBAT inhibitor, for the treatment of cholestatic pruritus in primary biliary cholangitis (PBC) pts; regulatory review is ongoing in the US, EU, UK & Canada NDA was supported by P-III (GLISTEN) trial assessing linerixibat (40mg) vs PBO to treat PBC pts…

ByRidhi RastogiFebruary 26, 2026

NEWS

ViiV Healthcare Reports P-IIb (EMBRACE) Trial Data on Lotivibart + Cabotegravir for HIV Treatment

Shots: ViiV Healthcare has reported 12mos. interim data from P-IIb (EMBRACE) trial assessing lotivibart (IV or SC, Q4M) + cabotegravir (CAB LA; IM, QM) vs SoC for the treatment of HIV lotivibart + cabotegravir maintained viral suppression in 94% of lotivibart IV & 82% of SC recipients vs 88%, with confirmed virologic failure in 4%…

ByRidhi RastogiFebruary 26, 2026

NEWS

GSK to Acquire 35Pharma for $950M

Shots: GSK has entered into an agreement to acquire 35Pharma, incl. its asset HS235, expanding scalable growth opportunities within its Respiratory, Immunology & Inflammation portfolio As per the deal, GSK will acquire 100% of 35Pharma’s equity for $950M in cash, payable at closing HS235, a therapy targeting the activin receptor signalling pathway, has completed P-I…

ByRidhi RastogiFebruary 25, 2026

NEWS

Frontier Biotechnologies and GSK Forge ~$1B Global Licensing Deal for siRNA Therapeutics

Shots: Frontier has entered into an exclusive licensing agreement with GSK for two Small Interfering RNA (siRNA) assets in immunology, incl. one IND-stage candidate & one preclinical program As per the deal, GSK will gain exclusive global rights to develop, manufacture, & commercialize two of Frontier’s siRNA candidates, while Frontier will receive $40M upfront, up…

ByRidhi RastogiFebruary 24, 2026

NEWS

GSK Reports the EC Approval of Exdensur (Depemokimab) for Asthma with Type 2 Inflammation and CRSwNP

Shots: EC approved Exdensur as an add-on maintenance therapy for asthma pts (≥12yrs.) with type 2 inflammation (eosinophilic) & as add-on therapy for inadequately controlled CRSwNP, based on P-III (SWIFT & ANCHOR) trials, respectively In SWIFT-1 (n=382) & SWIFT-2 (n=380), Exdensur reduced asthma exacerbations by 58% & 48% over 52wks. (1EP), with pooled data showing a 72%…

ByRidhi RastogiFebruary 17, 2026

NEWS

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

EMA Marketing Authorization of New Drugs in February 2026

GSK Receives the US FDA Approval of Arexvy to Prevent Respiratory Syncytial Virus (RSV) Disease

GSK Licenses Linerixibat’s Global Rights to Alfasigma in ~$690M Deal

GSK Reports the MHLW’s NDA Acceptance for Bepirovirsen to Treat Chronic Hepatitis B

GSK Reports the NMPA’s NDA Acceptance with Priority Review of Linerixibat for Cholestatic Pruritus

ViiV Healthcare Reports P-IIb (EMBRACE) Trial Data on Lotivibart + Cabotegravir for HIV Treatment

GSK to Acquire 35Pharma for $950M

Frontier Biotechnologies and GSK Forge ~$1B Global Licensing Deal for siRNA Therapeutics

GSK Reports the EC Approval of Exdensur (Depemokimab) for Asthma with Type 2 Inflammation and CRSwNP

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

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