JD Supra

Awash in Data? FDA Removes a Barrier in Real-World Evidence Generation

On December 15, 2025, the US Food and Drug Administration (FDA) issued a press release announcing that FDA eliminated a major ...
Ophthalmology Times

FDA grants single-patient expanded access for urcosimod in neuropathic corneal pain

FDA authorizes compassionate use of urcosimod for neuropathic corneal pain, a condition that causes severe pain and ...

FDA’s 2025 Biosimilar Draft Guidance: Strategic Considerations for Clients and Counsel

For companies developing interchangeable biosimilars, the FDA guidance opens the door to more tailored, risk-based programs that may reduce reliance on costly comparative efficacy studies (CES). For ...
JD Supra

FDA Issues Updated Guidance on Expanded Access to Investigational Drugs

The U.S. Food and Drug Administration (FDA) has issued updated guidance on Expanded Access to Investigational Drugs for Treatment Use, clarifying how drug developers, physicians, and patients can ...
Managed Healthcare Executive

FDA accepts NDA for gedatolisib, Celcuity’s investigational breast cancer treatment

The FDA has accepted a New Drug Application (NDA) for Celcuity’s gedatolisib in hormone receptor positive (HR+), human epidermal growth factor receptor 2 negative (HER2), PIK3CA wild-type advanced ...
Hosted on MSN

FDA's Makary wants to increase drug access, reduce 'addictive' foods

FDA Commissioner Marty Makary has an ambitious plan to overhaul how quickly patients can access drugs in the US, but also wants to reduce reliance on pharmaceuticals by shifting the focus of research ...