News | April 22, 2026
Astellas & Pfizer win FDA priority review for bladder cancer treatment expansion
A decision is expected by August 17, 2026 under the Prescription Drug User Fee Act timeline
A decision is expected by August 17, 2026 under the Prescription Drug User Fee Act timeline
OneSource is the contract development and manufacturing organization (CDMO) partner for this product
The approved product is a generic version of Ravicti, originally developed and marketed by Horizon Therapeutics
The drug is designed to provide temporary relief from cough caused by throat and bronchial irritation
The company stated that it will work closely with the regulator to address the observations within the stipulated timeframe
Zero-observation outcomes strengthen global credibility and accelerate CDMO ambitions
Move amid evidence of widespread reporting gaps
Panacea Biotec receives LoA from CMSS
The Stealth AXiS surgical navigation system was recently cleared by the US Food and Drug Administration (FDA) for cranial procedures in the United States
Final approval for progesterone vaginal inserts expands Glenmark’s women’s healthcare portfolio in the US, targeting a market of over $59 million
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