The trial is being carried out in 16 nations and regions, including Asia, North America, Europe, and South America.

Ocugen has announced the US Food and Drug Administration (FDA) has cleared the Investigational New Drug (IND) amendment to ...

The OCU410ST Phase 2/3 pivotal confirmatory trial represents a major advancement as Ocugen's second late-stage clinical program. Ocugen plans to submit a BLA for OCU410ST in 2027 in alignment with its ...

Luton, Bedfordshire, United Kingdom, June 20, 2025 (GLOBE NEWSWIRE) -- The global drug development testing services market is entering a phase of robust expansion, driven by a surge in clinical trial ...

China, already gaining speed in biotechnology, is looking to further accelerate novel drug development by reducing the time ...

The Commissioner’s National Priority Voucher can be used by drug developers to participate in a novel priority program for ...

The program will bring together experts from across the FDA for a team-based review, rather than having an application move ...

FDA approval of VYKAT XR for hyperphagia in Prader-Willi Syndrome marks a major milestone for Soleno Therapeutics.

KalVista Pharmaceuticals has become the latest biotech to face delays to the FDA’s decision-making, as the agency apparently ...

FDA Commissioner Martin Makary, MD, shared his vision for a “New FDA” with biopharma leaders attending BIO in Boston.

Oprah Winfrey and Elon Musk endorsed it. And though Indian celebrities haven’t yet admitted to their use, the mystery ...