logo. (PRNewsFoto/National Organization for Rare Disorders (NORD)) Vinay Prasad, MD, MPH, the newly appointed Director of the U.S. Food and Drug Administration (FDA) Center for Biologics ...

PARAMUS, N.J., May 14, 2025 /PRNewswire/ -- NS Pharma, Inc. (NS Pharma), a subsidiary of Nippon Shinyaku Co., Ltd. (Nippon Shinyaku) announced today that the U.S. Food and Drug Administration has ...

Facet Life Sciences specializes in guiding life science companies through the complex journey of drug, biologic, and medical device development and registration with the US FDA. Facet is pleased to ...

HADLIMA™ (adalimumab-bwwd) injection, 40 mg/0.4 mL & 40 mg/0.8 mL is now interchangeable with all high- and low-concentration presentations (autoinjector, prefilled syringe, and single-dose vial) of ...

Analysts at MarketsandMarkets expect the AI healthcare sector to grow at a 38.6% CAGR, topping $110 billion by 2030. Accenture goes even further, estimating AI could inject another $461 billion in ...

the newly appointed Director of the U.S. Food and Drug Administration (FDA) Center for Biologics Evaluation and Research (CBER), will deliver the keynote address. The Symposium will feature ...

The Food and Drug Administration will no longer approve COVID-19 vaccines for healthy people under 65 without rigorous trials ...

former director of the FDA’s Center for Biologics Evaluation and Research (CBER) that regulates vaccines, wrote in a resignation letter in March. A weekly newsletter by David Pierce designed to ...

announced today that the U.S. Food and Drug Administration has accepted for review the Biologics License Application (BLA) submission by REGENXBIO Inc. (REGENXBIO; Headquarters: Rockville ...

FDA Commissioner Marty Makary, M.D., and Center for Biologics Evaluation and Research (CBER) head Vinay Prasad, M.D., laid out the agency's “evidence-based approach to COVID-19 vaccination” in ...