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Shionogi Secures US FDA Approval of Xocova for PEP COVID-19 Prevention

Shots:  The US FDA has approved Xocova (ensitrelvir) for post-exposure prophylaxis (PEP) of COVID-19 in adults and adolescents (age≥12 yrs) following exposure to a person with COVID-19  Approval was based on a global P-III (SCORPIO-PEP) trial in 2,387 participants aged ≥12 yrs exposed to a household member with symptomatic COVID-19. The primary analysis included 2,041 SARS-CoV-2-negative participants who received Xocova (n=1,030; 375 mg on…
May 29, 2026

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NEWS

Wockhardt Receives US FDA Approval for Zaynich to Treat cUTI Including Pyelonephritis 

Shots:  The US FDA has approved Zaynich (Cefepime and Zidebactam) for treating adults with complicated urinary tract infections (cUTIs), including pyelonephritis, caused by susceptible Gram-negative bacteria  Approval was based on a P-III (ENHANCE-1) trial in 530 adults with cUTI or acute pyelonephritis across 64 global sites, where Zaynich demonstrated superior clinical and microbiological response rates vs. meropenem (89.0% vs. 68.4%) and was generally well tolerated  Zaynich is an injectable…
May 29, 2026

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NEWS

Haisco Pharmaceutical Secures US FDA Approval of Cypsedo for Adult General Anesthesia Prior to Surgery 

Shots:  The US FDA has approved Cypsedo (Cipepofol) to induce general anesthesia in adults undergoing surgery  Cipepofol (Chinese trade name: Sishuning) is China's first domestically developed Class 1 innovative intravenous anesthetic with global IP rights. It is approved in China for procedural sedation, induction and maintenance of general anesthesia, and ICU sedation during mechanical ventilation  In Dec 2020, Cipepofol, approved…
May 29, 2026

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NEWS

Alteogen Reports the MFDS Approval of Eyzanfy (Biosimilar, Eylea) 

Shots:  The Korean MFDS has approved Eyzanfy (ALT-L9), a biosimilar version of Eylea (aflibercept)  In 2025, ALT-L9 received EC approval as a brand name of Eyluxvi  Approval was based on P-III trial across 12 countries in 431 wAMD pts, demonstrating Eyluxvi’s efficacy, safety, and therapeutic equivalence comparable to Eylea  Ref: Alteogen | Image: Alteogen | Press Release Related News:- Alteogen’s Eyluxvi (Biosimilar, Eylea) Receives the CHMP’s…
May 15, 2026

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NEWS

Agenus Completes Strategic Collaboration with Zydus Lifesciences of ~$141M to Advance BOT+BAL Development & Expand US Manufacturing

Shots: Agenus has completed its strategic collaboration with Zydus Lifesciences to accelerate global development and potential commercialization of the BOT+BAL immunotherapy program As per the deal, Zydus gave $75M upfront payment to Agenus for US biologics manufacturing facilities, and Agenus is also eligible for Contingent Milestone Payments ~$50M in production-linked milestones. Zydus acquired common stock…
January 16, 2026

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Moderna
NEWS

Moderna Reports the CHMP Positive Opinion on mNEXSPIKE to Protect Against COVID-19 

 Shots:  The CHMP has recommended mNEXSPIKE (mRNA-1283), a COVID-19 vaccine, for active immunization against SARS-CoV-2 in individuals (age≥12 yrs)  Opinion was based on the P-III trial evaluating mNEXSPIKE (mRNA-1283; 10 µg) versus Spikevax (mRNA-1273; 50 µg) in ~11,400 participants (age ≥12 yrs), with primary efficacy assessed from 14 days post-vaccination  The trial met its 1EP with mNEXSPIKE showing 9.3% superior relative vaccine efficacy (rVE) in subjects (≥12yrs.), whereas in…
December 11, 2025

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