Vimseltinib is now an FDA-approved treatment for patients with tenosynovial giant cell tumor, based on findings from the ...
Going forward, we may see more instances in which insurers deny or (temporarily) severely restrict coverage of accelerated ...
GOMEKLI is the first and only medicine approved for both adults and children with NF1-PN –– Approval based on positive data ...
Alnylam awaits FDA decisions on Amvuttra & Fitusiran next month, poised to boost revenue, profitability, and share growth.
Adult and pediatric patients with neurofibromatosis type 1 who have symptomatic plexiform neurofibromas that are not amenable ...
On January 6, 2025, the FDA released draft guidance on using artificial intelligence (AI) in regulatory decision-making for ...
Medical Device Network on MSN8d
Supernus wins FDA approval for Parkinson’s pump on fourth trySupernus Pharmaceuticals has won US approval for its wearable pump Onapgo (apomorphine hydrochloride) to treat symptoms of ...
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 ...
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 ...
Specifically, the FDA approved Omvoh to treat moderately ... The U.K.’s Medicines and Healthcare products Regulatory Agency (MHRA) approved Winrevair in combination with other PAH therapies ...
Ghana News Agency (GNA) on MSN3d
FDA leads 7 African regulators to foster trust and accelerate access to medicinesThe Ghana Food and Drugs Authority (FDA) has spearheaded a joint initiative with National Regulatory Authorities (NRAs) in ...
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