FDA – CoolPal

Trump Demands Justification for COVID Drug Efficacy Amid CDC Leadership Crisis

2025-09-02 CoolPal

Trump Demands Justification for COVID Drug Efficacy Amid CDC Leadership Crisis President Donald Trump on Monday intensified calls for pharmaceutical companies to substantiate the effectiveness of their COVID-19 drugs, just days after the Food and Drug Administration (FDA) narrowed the scope of who can receive the latest virus vaccines. In a Truth Social post, Trump stated, “It is very important that the Drug Companies justify the success of their various Covid Drugs. Many people think they are a miracle that…

Vinay Prasad Reinstated at FDA Amid Renewed Controversy and Loomer Attacks

2025-08-10 CoolPal

Vinay Prasad Reinstated at FDA Amid Renewed Controversy and Loomer Attacks Just over a week after his contentious departure, Dr. Vinay Prasad has been reinstated as the head of the US Food and Drug Administration’s (FDA) Center for Biologics Evaluation and Research. The decision, confirmed by Department Health and Human Services spokesperson Andrew Nixon, sees Prasad returning to his critical role overseeing vaccine, gene therapy, and blood product regulation. Prasad, an oncologist known for his past criticisms of Covid-19 vaccine…

Sarepta Defies FDA Order to Halt Gene Therapy Shipments Amid Rising Patient Deaths

2025-07-20 CoolPal

Sarepta Defies FDA Order to Halt Gene Therapy Shipments Amid Rising Patient Deaths Sarepta Therapeutics has publicly defied a rare request from the U.S. Food and Drug Administration (FDA) to immediately suspend all shipments of its gene therapy, Elevidys, following the confirmed death of a third patient. The biopharmaceutical company’s refusal marks a highly unusual standoff with the federal agency, intensifying scrutiny on its leading Duchenne muscular dystrophy treatment. The FDA disclosed late Friday that it had met with Sarepta…

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