The FDA has approved an adeno-associated virus 9 gene replacement therapy to treat individuals aged 2 years and older with ...

Rare disease research faces complex regulations, small patient populations, and high costs. As traditional incentives wane, ...

The U.S. Food and Drug Administration's newly appointed head of the drug evaluation department, Richard Pazdur, is set to ...

The US Food and Drug Administration (FDA) has granted approval for Cleveland Diagnostics’ IsoPSA in vitro diagnostic (IVD) ...

The next critical steps in the USFDA process involve a rigorous on-site evaluation: "visiting manufacturing facilities, ...

Laws include restricting transgender people’s access to public bathrooms, allowing lawsuits against abortion pill providers, ...

FDA lowers surveillance requirement to 50 patients from 300 patients in original HDE approval based on assessment of first 21 SAVE Surveillance Registry patients ...

The Delhi High Court has given Dr Reddy’s Laboratories permission to manufacture and export semaglutide, the popular diabetes ...

Engineers inspect a line of enormous stainless-steel vats where a biologic drug will soon begin production, derived from cells originating in hamster ovaries. With each vat big enough to make 50,000 ...

The FDA plans to impose stricter vaccine approval rules, prompting warnings from Georgia doctors who fear the policy could ...

The Global Bioprocess Validation Market presents key opportunities driven by the growing demand for biologics and biosimilars ...

Following FDA rejections, Regeneron and Scholar Rock are turning to other facilities to clear regulatory logjams created by ...