Many consumer devices undergo the FDA clearance process, such as LED masks and fitness trackers that have features like ...

Going forward, we may see more instances in which insurers deny or (temporarily) severely restrict coverage of accelerated ...

Alnylam awaits FDA decisions on Amvuttra & Fitusiran next month, poised to boost revenue, profitability, and share growth.

GOMEKLI is the first and only medicine approved for both adults and children with NF1-PN –– Approval based on positive data ...

On January 6, 2025, the FDA released draft guidance on using artificial intelligence (AI) in regulatory decision-making for ...

Nasal vaccine devices have the potential to offer more convenient and more effective protection against a variety of viruses.

Supernus Pharmaceuticals has won US approval for its wearable pump Onapgo (apomorphine hydrochloride) to treat symptoms of ...

Adult and pediatric patients with neurofibromatosis type 1 who have symptomatic plexiform neurofibromas that are not amenable ...

NEW YORK - OS Therapies, Inc. (NYSE-A: OSTX), a small-cap biotech firm with a market capitalization of $42 million focusing on cancer treatment solutions, has announced the completion of its Phase 2b ...

Genentech Inc. won regulatory approval Tuesday to market an eye implant that can be refilled every six months with an already ...

The intravenous antibiotic Emblaveo, a combination of aztreonam and avibactam approved in Europe last year, was developed in ...