Tag Archives: Approves

FDA Approves Keytruda (pembrolizumab) for Recurrent Locally Advanced or Metastatic Squamous Cell Carcinoma of the Esophagus

Print this page KENILWORTH, N.J.–(BUSINESS WIRE) July 31, 2019 –Merck (NYSE: MRK), known as MSD outside the United States and Canada, today announced that the U.S. Food and Drug Administration (FDA) has approved Keytruda, Merck’s anti-PD-1 therapy, as monotherapy for the treatment of patients with recurrent locally advanced or metastatic squamous cell carcinoma of the… Read More »

FDA Approves Turalio (pexidartinib) for the Treatment of Symptomatic Tenosynovial Giant Cell Tumors (TGCT) in Adults

FDA Approves Turalio (pexidartinib) for the Treatment of Symptomatic Tenosynovial Giant Cell Tumors (TGCT) in Adults Print this page Today, the U.S. Food and Drug Administration granted approval to Turalio (pexidartinib) capsules for the treatment of adult patients with symptomatic tenosynovial giant cell tumor (TGCT) associated with severe morbidity or functional limitations and not responsive… Read More »

FDA Approves Hadlima (adalimumab-bwwd), a Biosimilar to Humira

FDA Approves Hadlima (adalimumab-bwwd), a Biosimilar to Humira Print this page INCHEON, Korea – July 24, 2019 – Samsung Bioepis Co., Ltd. today announced that the U.S. Food and Drug Administration (FDA) has approved Hadlima (adalimumab-bwwd), a biosimilar referencing Humira (adalimumab)i, for the treatment of rheumatoid arthritis, juvenile idiopathic arthritis, psoriatic arthritis, ankylosing spondylitis, adult… Read More »

FDA Approves Nayzilam (midazolam) Nasal Spray to Treat Seizure Clusters

FDA Approves Nayzilam (midazolam) Nasal Spray to Treat Seizure Clusters Print this page Brussels (Belgium) & Atlanta, Georgia (U.S.) – May 20 2019: UCB announced today that the U.S. Food and Drug Administration (FDA) has approved a New Drug Application for the company’s newest anti-epileptic drug (AED) Nayzilam (midazolam) nasal spray CIV, a benzodiazepine indicated… Read More »

FDA Approves Broadened Indication for Xeomin (incobotulinumtoxinA) as First-Line Treatment for Blepharospasm (Involuntary Blinking) in Adult Patients

Print this page RALEIGH, N.C.  –  May 13,  2019  –  Merz Americas announced today that the U.S. Food and Drug Administration (FDA) has approved the supplemental Biologics License Application (sBLA) for Xeomin (incobotulinumtoxinA), broadening its indication to be a first-line treatment of blepharospasm (involuntary blinking) in adult patients. “Merz is proud to offer a first-line… Read More »