GOMEKLI is the first and only medicine approved for both adults and children with NF1-PN – – Approval based on positive data from Phase 2b ReNeu trial, which showed ...
“This is another key milestone as we expand our reach to the UK following successful approval across Europe for our innovative infertility and cancer detection products.” stated Kathy Lee-Sepsick, ...
Biohaven (BHVN) announced that the FDA has accepted for review the company’s New Drug Application, or NDA, for troriluzole for the treatment of ...
There's growing evidence to suggest that GLP-1 drugs, which include semaglutide, may be useful for treating alcohol use disorder.
A Dayton-area medical technology firm has recently had its AI-driven image processing and analysis technology cleared by the ...
Ten months after Pfizer scored approval in Europe for Emblaveo (aztreonam and avibactam) to treat complicated intra-abdominal infections (cIAIs), AbbVie has done the same in the U.S., ...
AIM Vaccine Co., Ltd., a leading PRC vaccine company, announced today that its independently developed mRNA RSV (respiratory syncytial virus) vaccine has recently been submitted for clinical trials to ...
Ariceum Therapeutics (Ariceum), a private biotech company developing radiopharmaceutical products for the diagnosis and treatment of certain hard-to-treat cancers, today announced that the U.S. Food ...
The groundbreaking decision is a win for harm reduction, though it also highlights absurd contradictions in the FDA's overall ...
Supernus Pharmaceuticals has won US approval for its wearable pump Onapgo (apomorphine hydrochloride) to treat symptoms of ...
The U.S. Food and Drug Administration has approved Onapgo (apomorphine hydrochloride) injection as the first and only ...