Here’s What the FDA Label on Your Personal Care Products Means
Many consumer devices undergo the FDA clearance process, such as LED masks and fitness trackers that have features like ...
Insurer Denies Access To Drugs Granted Accelerated Approval By FDA
Going forward, we may see more instances in which insurers deny or (temporarily) severely restrict coverage of accelerated ...
UPDATE: SpringWorks Therapeutics Announces FDA Approval of GOMEKLIâ„¢ (mirdametinib) for the Treatment of Adult and Pediatric Patients with NF1-PN
GOMEKLI is the first and only medicine approved for both adults and children with NF1-PN –– Approval based on positive data ...
Targeted Oncology1d
Vimseltinib Gains FDA Approval in Tenosynovial Giant Cell Tumor
Vimseltinib is now an FDA-approved treatment for patients with tenosynovial giant cell tumor, based on findings from the ...
Alnylam: Waiting For Regulatory Updates In March
Alnylam awaits FDA decisions on Amvuttra & Fitusiran next month, poised to boost revenue, profitability, and share growth.
The American Journal of Managed Care3d
FDA Approves Mirdametinib for Neurofibromatosis Type 1 With Plexiform Neurofibromas
Adult and pediatric patients with neurofibromatosis type 1 who have symptomatic plexiform neurofibromas that are not amenable ...
Hosted on MSN9d
Supernus wins FDA approval for Parkinson’s pump on fourth try
Supernus Pharmaceuticals has won US approval for its wearable pump Onapgo (apomorphine hydrochloride) to treat symptoms of ...
JD Supra2d
From Algorithms to Approvals: Navigating AI in Drug and Biological Product Regulation
On January 6, 2025, the FDA released draft guidance on using artificial intelligence (AI) in regulatory decision-making for ...
GlobalData on MSN10d
Alys Pharmaceuticals receives regulatory approvals for alopaecia areata drug trial
US-based immuno-dermatology company Alys Pharmaceuticals has received clearance from the US Food and Drug Administration (FDA ...
With FDA approval, Genentech turns eye implant's focus to diabetes
Genentech Inc. won regulatory approval Tuesday to market an eye implant that can be refilled every six months with an already ...
BioSpace5d
AbbVie Gets FDA Approval for New Antibiotic in the Face of Rising Resistance
The intravenous antibiotic Emblaveo, a combination of aztreonam and avibactam approved in Europe last year, was developed in ...
Vertex Pharmaceuticals Just Won a Huge FDA Approval. Is the Biotech Stock a No-Brainer Buy?
Vertex Pharmaceuticals ( VRTX 5.31%) just snagged its second U.S. Food and Drug Administration (FDA) approval in only 41 days. On Dec. 20, 2024, the FDA gave a thumbs-up to Alyftrek in treating cystic ...