Drug Approval | January 14, 2026
Camurus’ Oclaiz NDA resubmission accepted by FDA
The FDA has set a Prescription Drug User Fee Act (PDUFA) target action date of June 10, 2026
The FDA has set a Prescription Drug User Fee Act (PDUFA) target action date of June 10, 2026
The clearance marks a major step in Diabeloop’s ambition to become a central partner for insulin pump manufacturers and expand access to automated insulin delivery in the US market
The deal brings Labcorp’s U.S. portfolio—including biocompatibility, microbiological, and analytical testing, as well as preclinical research—under NAMSA’s roof
GlideTech materials are available in several standard base resins and offer customization options for specific applications
India should explore Sustainability-Linked Incentives (SLI) targeting innovations in the 12 principles of green chemistry
The portfolio, purchased from a leading multinational generic manufacturer, addresses a market valued at $473.2 million for the 12 months ending August 2025
The resubmission of BLA for MOLBREEVI names Fujifilm as the drug substance manufacturer
The study will run across 18 sites and enroll roughly 200 patients over 24 months
The agreement to sell B Medical Systems marks a major step forward in simplifying the portfolio to prioritize our core capabilities with the highest strategic impact
Wayrilz represents a new approach to ITP by targeting the disease at its root through multi-immune modulation
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