FDA approves first rapid-acting insulin biosimilar for patients with diabetes
Aventis's Merilog (insulin-aspart-szjj) as a biosimilar to Novolog (insulin aspart) for adults and pediatric patients with ...
infectiousdiseaseadvisor.com1d
FDA Drug Approval Decisions Expected in March 2025
The Prescription Drug User Fee Act (PDUFA) date refers to the deadline set by the US Food and Drug Administration (FDA) for reviewing a New Drug Application (NDA) or Biologics License Application (BLA ...
Monthly Prescribing Reference3h
FDA Approves Vimkunya to Protect Against Chikungunya Virus
Vimkunya is supplied as an injectable suspension; the vaccine is administered intramuscularly as a single 0.8mL dose.
FDA approves Romvimza for tenosynovial giant cell tumor (TGCT)
The U.S. Food and Drug Administration (FDA) has approved vimseltinib (Romvimza) for adult patients with a rare condition ...
Becker's Hospital Review6h
FDA approves generic cancer treatment for 2026 availability
The FDA has approved a generic version of lenalidomide, a drug used to treat multiple myeloma and myelodysplastic syndromes, with availability set for Jan. 31, 2026.
FDA approves new genetic disorder drug
The Food and Drug Administration (FDA) approved a new drug to treat a disorder causing the growth of noncancerous tumors on ...
US FDA approves SpringWorks' genetic disorder drug
The U.S. Food and Drug Administration said on Tuesday it has approved SpringWorks Therapeutics' drug to treat a type of rare ...
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 ...
KOMU2d
FDA approves first drug to aid sleep apnea; drug also results in weight loss
The FDA approved a new drug called Zepbound, which activates GLP-1 to help with obstructive sleep apnea, while also resulting ...
Cure Today1d
Understanding the FDA Approval of Enhertu in HER2-Low and -Ultralow Breast Cancer
Dr. Debu Tripathy breaks down the FDA approval of Enhertu in unresectable or metastatic HR-positive, HER2-low or -ultralow ...
OnePlus seeks FDA approval for Sleep Apnea Detection on its watch and takes on Apple in the process
OnePlus is hoping the OnePlus Watch 3 could get FDA approval for its new sleep apnea detection feature, bringing it one step closer to rivaling the best Apple Watches.
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FDA approves first-ever rapid-acting insulin biosimilar for diabetes treatment
First-ever rapid-acting insulin. This approval extends to a 3-milliliter single-patient-use prefilled pen and a 10-milliliter ...