557 Results

FDA accepts Avycaz sNDA to include the treatment of complicated urinary tract infections and complicated intra-abdominal infections in pediatric patients . Allergan.

 Added 24 days ago

Allergan plc announced that the FDA has accepted for review the company's supplemental New Drug Application (sNDA) for AvyCaz(ceftazidime and...

CHMP recommends update to indication for Ravicti in urea cycle disorders.- Horizon Pharma.

 Added 26 days ago

The Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion recommending a change to the terms of...

CHMP positive for Yervoy + Opdivo combination to treat first line renal cell carcinoma. - BMS

 Added 26 days ago

Bristol-Myers Squibb Company announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency adopted...

FDA approves expended label for Promacta to include first-line treatment for adults and pediatric patients two years and older with severe aplastic anemia.-Novartis

 Added 27 days ago

Novartis announced that the FDA has expanded the label for Promacta (eltrombopag) to include first-line treatment for adults and pediatric...

CHMP opinion for Erleada for patients with non-metastatic castration-resistant prostate cancer. Janssen Pharma

 Added 28 days ago

The Janssen Pharmaceutical Companies of Johnson & Johnson announced that the Committee for Medicinal Products for Human Use (CHMP) of...

FDA grants De Novo clearance for Innovo device for the treatment of stress urinary incontinence.- Atlantic Therapeutics.

 Added 29 days ago

Atlantic Therapeutics, a global manufacturer of innovative, garment-based pelvic floor muscle strengthening and nerve stimulation products, announced that the FDA...

Pooled data from phase III studies, shows terlipressin was associated with improved overall and transplant-free survival in hepatorenal syndrome type 1 patients.- Mallinckrodt

 Added 1 month ago

Mallinckrodt plc , announced results of a pooled analysis of terlipressin clinical trial data in patients with hepatorenal syndrome type...

Positive Phase III TIVO-3 trial of tivozanib to treat refractory advanced or metastatic renal cell carcinoma.- Aveo Oncology.

 Added 1 month ago

AVEO Oncology announced positive topline results from the primary analysis of the TIVO-3 trial, the Company’s Phase III randomized, controlled,...

Contepo filed with FDA for complicated urinary tract infections.- Nabriva Therapeutics.

 Added 1 month ago

Nabriva Therapeutics has submitted a New Drug Application (NDA) to the FDA to seek marketing approval for its investigational intravenous...

District Court invalidates all asserted claims of U.S. Patent No. 8,822,438 for Zytiga.- Johnson + Johnson

 Added 1 month ago

Johnson & Johnson has announced that the United States District Court, District of New Jersey has issued a ruling invalidating...

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