Tag Archive for: FDA

Agency inspectors found problems with record keeping and quality controls for animal experiments at Elon Musk’s Neuralink, less than a month after the startup said it was cleared to test its brain implants in humans, according to an agency report reviewed by Reuters.

The U.S. drug regulator is set to increase the number of inspections at Indian drug manufacturing units in 2024 amid growing concerns over the quality of drugs, according to reports.

Despite a patent extension, Merck’s muscle relaxant reversal injection is now facing potential generic competition from Hikma Pharmaceuticals, which is seeking the FDA’s approval for a copycat version.

The FDA stated that it has not authorized, cleared, or approved any smartwatch or smart ring that is intended to measure or estimate blood glucose values on its own.

The company has filed a case with the U.S. FDA, alleging that due procedure was not followed in allowing rival Liquidia Corp’s application for a blood pressure drug.

Rapt Therapeutics said on Tuesday the U.S. FDA had placed on hold two mid-stage trials of the company’s drug to treat eczema and asthma, after liver failure was observed in one of the patients.

The progression-free survival metric has helped shepherd many products across the regulatory finish line. Experts say the FDA’s new emphasis on overall survival will be felt especially by small biotechs.

As the last full month of winter 2024 nears an end, the FDA has two target action dates: one for a Humira biosimilar and another for a schizophrenia treatment. 

The drug would be used to treat adults with a type of advanced lung cancer, AstraZeneca said, adding that the FDA’s approval was based on trials which extended median progression-free survival (PFS) by nearly nine months.

US FDA grants accelerated approval for Iovance’s skin cancer cell therapy Feb 16 (Reuters) – Iovance Biotherapeutics (IOVA.O) said on Friday the U.S. health regulator has granted an accelerated approval for its […]