Lannett Company Inc. now has access to “the lion's share of the market” for newly approved dosage strengths of its hydrocodone bitartrate and acetaminophen tablets following recent FDA authorization, according to Lannett CEO Arthur Bedrosian. Read More »
Halozyme Therapeutics Inc.'s Genentech’s Rituxan Hycelatm, which uses Halozyme’s hyaluronidase human enhance technology, was approved by the U.S. Food and Drug Administration for subcutaneous injection in multiple blood cancer indications. Read More »
AbbVie's chronic hepatitis C virus infection drug, Maviret, was granted a positive opinion by the European Committee for Medicinal Products for Human Use of the European Medicines Agency. Read More »
Amgen recently announced that its Mimpara drug has been given a positive opinion by the Committee for Medicinal Products for Human Use of the European Medicines Agency. Read More »
Sandoz's Abbreviated New Drug Application for fluticasone propionate/salmeterol combination product, a substitutable generic version of Advair Diskus, was accepted by the U.S. Food and Drug Administration. Read More »
Ipsen Biopharmaceuticals Inc., an affiliate of Ipsen SA, has had its Dysport injection for treating spasticity in adults approved for expanded use by the U.S. Food and Drug Administration. Read More »
CSL Behring's Haegarda drug, the only subcutaneous therapy for preventing hereditary angioedema attacks in both adolescents and adults, was approved by the U.S. Food and Drug Administration. Read More »
Lexicon Pharmaceuticals Inc. recently presented its two sotagliflozin studies, inTandem1 and inTandem2, at the 77th American Diabetes Association Scientific Sessions in San Diego, California. Read More »
Janssen Biotech's Darzalex immunotherapy was approved by the U.S. Food and Drug Administration for treating patients with multiple myeloma in combination with pomalidomide and dexamethasone. Read More »
Pfizer Inc. recently published noninferiority results from its study of Xeljanz, a twice-daily monotherapy to be used in combination with methotrexate in treating patients with moderate to severe rheumatoid arthritis. Read More »
DelMar Pharmaceuticals recently presented a poster on dianhydrogalactitol at the Society for Neuro-Oncology's 4th Pediatric Neuro-Oncology Basic and Translational Research Conference, which took place at the Wyndham New Yorker Hotel in New York City in June. Read More »
Egalet Corp. of Pennsylvania recently obtained a complete response letter from the U.S. Food and Drug Administration about its Oxaydo tablets in 10 mg and 15 mg dosage strengths. Read More »
A decade-long study of GSK’s Benlysta — the longest to date — recently culminated with indications of the drug’s safety and efficacy against active systemic lupus erythematosus, when administered with standard care. Read More »
Two DelMar Pharmaceuticals Inc. executives recently accepted requests to join the National Brain Tumor Society's Research Roundtable, attending its premiere meeting in Washington, D.C. to consider ways research can improve clinical trials for regulatory approval. Read More »
New Haven, Connecticut-based Biohaven Pharmaceutical Holding Company Ltd.’s BHV-5000 compound developed to treat Rett syndrome recently attained orphan drug designation from the U.S. Food and Drug Administration (FDA), its fourth product to achieve the status. Read More »
Pediatric-onset hypophosphatasia, an extremely rare metabolic disease affecting bone structure and strength, came into sharper focus recently when Alexion Pharmaceuticals won funding for its Strensiq medication from two sources via a managed access agreement. Read More »
Cardiome Pharma Corp. partner SteadyMed Ltd. has submitted a New Drug Application for Trevyent with the U.S. Food and Drug Administration. Read More »
Novo Nordisk is recalling insulin cartridge holders of the NovoPen Echo model, warning that they may crack if they are in the presence of chemicals, such as those found in cleaners. Read More »
Pfizer Inc. and Merck released positive data from two Phase 3 studies of ertugliflozin, an investigational oral GGLT-2 inhibitor that seeks to treat Type 2 diabetes patients by improving glycemic control. Read More »
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