Teva Pharm CEO calls for faster US generic drug approvals
U.S. President Donald Trump's administration needs to speed up generic drug approvals and exempt some drugs from funding ...
Medscape6d
FDA Approves Vimseltinib for Tenosynovial Giant Cell Tumors
The US Food and Drug Administration has approved vimseltinib (Romvimza, Deciphera Pharmaceuticals, LLC) to treat adult ...
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 ...
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.
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 approves new pain medication as an alternative to opioids: What to know about Journavx
The FDA on Thursday approved a new class of pain medication that provides an alternative to opioids. It will be sold under the brand name Journavx.
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 ...
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 ...
FDA approves new, non-opioid painkiller Journavx
The drug, shown to be almost as effective as opioids for short-term pain, is the first fundamentally new kind of painkiller to win FDA approval in more than 20 years.
C&EN6d
FDA approves drug for neurofibromatosis
The US Food and Drug Administration has approved mirdametinib for the treatment of neurofibromatosis type 1 (NF1) in adults ...
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FDA approves first-ever rapid-acting insulin biosimilar for diabetes treatment
The FDA has approved Merilog, the first-ever rapid-acting insulin biosimilar for diabetes treatment that helps manage blood ...
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 ...