Drug Approval | December 14, 2025
FDA completes inspection of SMS Pharma’s Vizag facility
The inspection concluded with one minor observation in Form 483
The inspection concluded with one minor observation in Form 483
Updated results from the EMBER-3 study showed that the drug -- Inluriyo (imlunestrant) -- as a standalone treatment cut the risk of progression or death by 38%
GSK holds exclusive global rights (excluding mainland China, Hong Kong, Macau, and Taiwan) from Hansoh Pharma to advance its development and commercialization
The Phase 3 HER2CLIMB-05 trial showed a 35.9% reduction in risk for patients treated with TUKYSA
Retatrutide, tested at 9 mg and 12 mg doses alongside diet and exercise, met all primary and key secondary endpoints
This partnership strengthens LMS as a leading CDMO supplier of peptide materials for both innovator and generic markets
The company has unveiled the results of pirtobrutinib from its BRUIN CLL-313 study
The new site will produce next-generation synthetic medicine active pharmaceutical ingredients
HYMPAVZI’s safety profile was generally favorable
Takeda will pay Innovent US$1.2 billion upfront, including a US$100 million equity investment in Innovent
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