Neuralink has claimed in a tweet that it has finally received approval from the FDA to start a first-in-human clinical trial of its brain implant chip – but hasn’t indicated when it may start.

The new director at the FDA overseeing medical devices will confront criticisms about hasty approvals as she ushers in ...

The U.S. Food and Drug Administration (FDA) approved Hympavzi (marstacimab-hncq) for routine prophylaxis to prevent or reduce the frequency of bleeding episodes in adult and pediatric patients ...

The FDA has approved a new oral antibiotic to treat uncomplicated urinary tract infections. Orylnvah is a broad-spectrum oral penem antibiotic for women who have limited or no alternative ...

As therapies for rare and neurological diseases earn accelerated approval, experts laud the program’s intent while remaining ...

FDA approves Autolus Therapeutics' Aucatzyl for adults with relapsed or refractory B-cell precursor acute lymphoblastic ...

The product is expected to be available in the first half of 2025. The Food and Drug Administration (FDA) has approved Imuldosa ™ (ustekinumab-srlf), a biosimilar to Stelara ® (ustekinumab ...

Novocure received a long-sought FDA approval for the use of its Tumor Treating Fields technology against metastatic non-small cell lung cancer—which the company described as the first treatment ...

Autolus Therapeutics said it received Food and Drug Administration approval of its treatment of acute lymphoblastic leukemia, or ALL, an aggressive blood and bone marrow cancer, for certain patients.

The US Food and Drug Administration (FDA) has approved AbbVie's VYALEV (foscarbidopa and foslevodopa) to treat motor fluctuations in adults with advanced Parkinson's disease (PD). The chronic ...

This is the first approved indication for Orlynvah and the first FDA-approved product for Iterum. The FDA approval was based on a clinical development program, including two Phase 3 clinical trials.

Pfizer (PFE) announced that the U.S. FDA has approved Abrysvo, the company’s bivalent RSV prefusion F vaccine, for the prevention of lower respiratory tract disease caused by RSV in individuals ...