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Mylan Expands Access to HIV/AIDS Medicines with Launch of First Generic Sustiva® Tablets
Friday, February 02, 2018Global pharmaceutical leader Mylan NV today announced the US launch of Efavirenz Tablets USP mg the first generic version of BristolMyers Squibbs Sustiva The product is indicated in combination with other antiretroviral agents for the treatment of h...
Syndax Announces Immuno-Oncology Clinical Trial Collaboration with AstraZeneca
Friday, February 02, 2018Syndax Pharmaceuticals Inc a clinical stage biopharmaceutical company developing an innovative pipeline of cancer therapies today announced a new clinical collaboration with AstraZeneca to evaluate the safety and efficacy of AstraZenecas durvalumab a...
Aquestive Therapeutics Receives U.S. FDA Orphan Drug Designation for Riluzole Oral Soluble Film to Treat ALS
Thursday, February 01, 2018Aquestive Therapeutics Inc today announced that the US Food and Drug Administration FDA has granted orphan drug designation to Riluzole Oral Soluble Film riluzole OSF for the treatment of amyotrophic lateral sclerosis ALS a debilitating disease affec...
Ferring's ZOMACTON® (somatropin) for Injection Receives FDA Approval to Treat Growth Hormone Deficiency in Adults
Thursday, February 01, 2018Ferring Pharmaceuticals Inc today announced that the US Food and Drug Administration FDA has approved ZOMACTON somatropin for Injection mg and mg recombinant human growth hormone GH indicated for replacement of GH in adults with GH deficiency Ad...
Upsher-Smith Receives FDA Approval For Bumetanide Tablets, USP
Wednesday, January 31, 2018UpsherSmith Laboratories LLC UpsherSmith today announced that it has received US Food and Drug Administration FDA approval of its abbreviated new drug application ANDA for Bumetanide Tablets USP mg mg and mg Bumetanide Tablets are a generic versio...
FDA Grants Orphan Drug Designation to Dauntless Pharmaceuticals' DP1038 for the Treatment of Acromegaly
Wednesday, January 31, 2018Dauntless Pharmaceuticals Inc a privately held biopharmaceutical company focused on the development of specialty therapeutics announces that the US Food and Drug Administration FDA has granted orphan drug designation to DP the companys investigationa...
Takeda's Zika Virus Vaccine Receives FDA Fast-Track Designation
Tuesday, January 30, 2018Takeda Pharmaceutical Company Limited today announced that the US Food and Drug Administration FDA has granted Fasttrack designation for TAK Takedas purified inactivated aluminum adjuvant vaccine against Zika virus The FDAs Fast Track designation...
CutisPharma Announces FDA Approval Of FIRVANQ™ For Treatment Of Clostridium Difficile Associated Diarrhea (CDAD) And Staphylococcus Aureus Colitis
Tuesday, January 30, 2018CutisPharma announced today that the US Food and Drug Administration FDA has approved FIRVANQ vancomycin hydrochloride for oral solution for the treatment of Clostridium difficile associated diarrhea and enterocolitis caused by Staphylococcus aureus...
Chugai's HEMLIBRA® Gains Positive CHMP Opinion in Hemophilia A with Inhibitors
Monday, January 29, 2018Chugai Pharmaceutical Co Ltd announced that Roche has received notification that the EU Committee for Medicinal Products for Human Use CHMP adopted a positive opinion for HEMLIBRA emicizumab for routine prophylaxis of bleeding episodes in people with...
CASI Pharmaceuticals Acquires ANDA Portfolio From Sandoz Inc. (Sandoz)
Monday, January 29, 2018CASI Pharmaceuticals Inc a biopharmaceutical company dedicated to bringing quality pharmaceutical products to the Chinese and US markets announced today that it has acquired a portfolio of US FDAapproved abbreviated new drug applications ANDAs one A...
