US FDA approves GSK's combo meningococcal vaccine
The U.S. Food and Drug Administration approved British drugmaker GSK's combination vaccine to protect against meningococcal ...
Business Wire11h
U.S. FDA Grants Full Approval of Deciphera’s ROMVIMZA™ (vimseltinib) for the Treatment of Symptomatic Tenosynovial Giant Cell Tumor (TGCT)
Ono Pharmaceutical Co., Ltd. (Headquarters: Osaka, Japan; President: Toichi Takino; “Ono”) announced that the U.S. Food and Drug Administration (FDA) ...
MedPage Today12h
FDA OKs First Rapid-Acting Insulin Biosimilar for Diabetes
The FDA approved insulin-aspart-szjj (Merilog) as the first rapid-acting insulin biosimilar product to treat adults and ...
C&EN13h
FDA approves drug for neurofibromatosis
The US Food and Drug Administration has approved mirdametinib for the treatment of neurofibromatosis type 1 (NF1) in adults ...
Sanofi gets FDA approval for NovoLog insulin biosimilar
Sanofi (NASDAQ:SNY) has received FDA approval for Merilog, a biosimilar of Novo Nordisk's (NVO) rapid-acting insulin product NovoLog, for the improvement of glycemic control in adults and children ...
FDA approves Sanofi biosimilar product for treatment of diabetes
The U.S. Food and Drug Administration approved Merilog as biosimilar to Novolog for the improvement of glycemic control in adults and pediatric ...
Healio18h
FDA approves Evrysdi tablets for spinal muscular atrophy
The FDA has approved Evrysdi in tablet form for patients with spinal muscular atrophy aged 2 years and older who weigh more ...
SMA20h
FDA approves new tablet version of oral SMA treatment Evrysdi
The U.S. Food and Drug Administration (FDA) has approved a new tablet formulation of Evrysdi (risdiplam), an approved oral ...
FDA Grants Fast-Track Designation To Cannabis Withdrawal Syndrome Drug
U.S.-based PleoPharma announced yesterday that the FDA has granted it a fast-track designation for PP-01, a new ...
JD Supra1d
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On January 6, 2025, the FDA released draft guidance on using artificial intelligence (AI) in regulatory decision-making for ...
Minnesota-invented patch for premature ejaculation gains FDA approval
A Minnesota company’s electrified men’s sexual health patch — once the victim of late night host Jimmy Kimmel’s jokes — is coming to consumers. Morari Medical, based in Maple Grove, raised millions of ...