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 ...

Disruptedcategory Musk's Neuralink gets FDA's breakthrough device tag for 'Blindsight' implant September 18, 2024 Healthcare & Pharmaceuticalscategory Musk's Neuralink says second trial implant ...

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 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 ...

On October 15th, NovoCure Limited received FDA approval of its lung cancer treatment, which resulted in positive price action. The lung cancer market will significantly increase NovoCure's scale ...

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.

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 ...

Paediatric patients with narcolepsy will now have access to Avadel’s Lumryz (sodium oxybate) after the US Food and Drug Administration (FDA) approved a supplemental new drug application.

(RTTNews) - Iterum Therapeutics plc (ITRM) Friday announced that the U.S. Food and Drug Administration (FDA) has approved Iterum's new drug application for Orlynvah (sulopenem etzadroxil and ...

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 ...