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Ultragenyx Pharmaceutical said federal regulators have issued a complete response letter to its application for a metabolic disorder treatment that may delay the potential approval to 2026.

The Food and Drug Administration (FDA) can maintain its high bar for safety and efficacy, and also cut the waste and unnecessary delays in the regulatory process.

Matt Bellina Regained Function After Receiving NurOwn via the Right to Try Law He Fought to Pass and Now He is Fighting for ...

The U.S. Food and Drug Administration may reportedly fast-track new drugs from pharmaceutical companies that “equalize” the ...

Novartis cannot block drugmaker MSN Pharmaceuticals from launching a generic version of its blockbuster heart-failure drug ...

FDA Commissioner Marty Makary suggests his agency may expedite drug reviews for manufacturers reducing U.S. prices to global ...

Food and Drug Administration Commissioner Marty Makary said his agency may fast-track new drugs from pharmaceutical companies that “equalize” the cost of their medicines between the US and other ...

To mark his first 100 days as head of the FDA, Martin Makary is touting his efforts to change the agency’s operations. The Food and Drug Administration ...

President Donald Trump posted a letter to social media Thursday evening announcing Canadian goods will be subject to a 35% ...

US regulators approved Moderna Inc.’s COVID-19 vaccine for children, but for a narrower group than before, continuing Robert ...

The letters, many of which were already available online, detail why the regulators initially declined to approve some drugs.