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 ...
FDA approves new genetic disorder drug
The Food and Drug Administration (FDA) approved a new drug to treat a disorder causing the growth of non-cancerous tumors on ...
Miamisburg-based Riverain Technologies receives FDA clearance for AI-powered imaging software
A Dayton-area medical technology firm has recently had its AI-driven image processing and analysis technology cleared by the ...
Ophthalmology Advisor1d
FDA Approves Wearable Infusion Device for Advanced Parkinson Disease
The US Food and Drug Administration has approved Onapgo (apomorphine hydrochloride) injection as the first and only subcutaneous apomorphine infusion device for the treatment of motor fluctuations in ...
Filter4d
FDA’s Authorization of Zyn Nicotine Pouches a Step in the Right Direction
The groundbreaking decision is a win for harm reduction, though it also highlights absurd contradictions in the FDA's overall ...
Medical Device Network on MSN5d
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 ...
Mother’s wrongful death lawsuit claims daughter from Scranton died from kratom use
A wrongful death lawsuit claims a Scranton woman died from a product containing kratom, a botanical native to Southeast Asia. With a scientific name of Mitragyna speciosa, kratom is a tropical tree in ...
Genentech : FDA Approves Susvimo For Diabetic Macular Edema Treatment
Genentech, a member of the Roche Group (RHHBY), announced that the U.S. Food and Drug Administration has approved Susvimo ...
FDA approves new type of nonopioid painkiller for acute pain
The drug, Journavx, from Vertex Pharmaceuticals, reduced pain after surgery in clinical trials. Experts hope it can lead to fewer opioid prescriptions.
FiercePharma11d
Axsome secures hard-fought FDA nod for rapid-acting migraine drug Symbravo
The FDA also warns of the potential of developing gastrointestinal side effects, such as ulcers. The approval comes after the ...
FDA approves Vertex's non-opioid painkiller, first new kind of pain medicine in decades
The Vertex drug is a milestone after a long history of unsuccessful efforts to develop painkillers without the addictive ...
Nasdaq15d
FDA Approves AstraZeneca And Daiichi Sankyo's ENHERTU For HER2-Low/Ultralow Breast Cancer
as determined by a Food and Drug Administration (FDA)-approved test, that has progressed on one or more endocrine therapies in the metastatic setting. ENHERTU is a specifically engineered HER2 ...