Seattle Genetics Inc. has submitted a Biologics License Application (BLA) to the U.S. Food and Drug Administration using data from its recent Phase 3 Alcanza trial and two Phase 2 investigator-sponsored trials of Adcetris. Read More »
Biohaven Pharmaceutical Holding Co. has been granted Fast Track Designation for its product candidate Trigriluzole by the FDA. Read More »
To combat certain types of influenza, Lannett Co. Inc. can now market its Amantadine Hydrochloride Capsules USP in 100 mg. dose form following Food and Drug Administration approval of its Abbreviated New Drug Application. Read More »
Philadelphia-based Lannett Company Inc. recently obtained approval from the U.S. Food and Drug Administration (FDA) for its generic formulation of niacin in extended-release form, with the product available in both 500-mg and 1000-mg tablet doses. Read More »
OncoSec Medical Inc.'s pIL-12 drug, also known as tavokinogene telsaplasmid, has been given an Orphan Drug Designation by the U.S. Food and Drug Administration. Read More »
Amgen and Allergan's data supporting their Biologics License Application for ABP 215, a biosimilar candidate to Avastin (bevacizumab), will be reviewed by the Oncologic Drugs Advisory Committee of the U.S. Food and Drug Administration by July 13. Read More »
Do television ads by plaintiffs' lawyer firms hawking lawsuits over prescription drugs cause patients to cease taking their prescribed prescriptions? Read More »
Alkermes PLC’s Aristada (aripiprazole lauroxil) injectable medication has won approval from the U.S. Food and Drug Administration as an extended-release injectable suspension to treat schizophrenia. Read More »
Sanofi Pasteur's Quadracel vaccine has been approved by the U.S. Food and Drug Administration to protect children between the ages of 4 and 6 against diphtheria, tetanus, pertussis and poliomyelitis. Read More »
Enanta Pharmaceuticals Inc.'s New Drug Application (NDA) for its pan-genotypic regimen of glecaprevir/pibrentasvir (G/P), developed in conjunction with AbbVie, has been accepted by the U.S Food and Drug Administration. Read More »
Spinraza (nusinersen) recently won European Commission authorization to treat 5q SMA — the most common form of spinal muscular atrophy — becoming the first such drug to achieve European approval, manufacturer Biogen announced from Cambridge, Massachusetts. Read More »
Trumenba, Pfizer’s branded vaccine against certain forms of meningococcal disease, officially won approval from the European Commission for patients aged 10 years and up, representing progress for protection in the young adult demographic. Read More »
The U.S. Supreme Court issued a 9-0 ruling today that will have the effect of speeding the process for biosimilars going to market. Read More »
A pioneering prototype blending a mood stabilizer with technology is on the radar for two companies determined to develop a combination drug/device that, if approved by the FDA, could potentially address serious mental health challenges. Read More »
With kidney disease ranking in the nation’s top 10 causes of death, Sanofi recently announced a breakthrough with FDA approval of its branded Thymoglobulin for boosting immunosuppression for patients to prevent rejection following kidney transplants. Read More »
Pfizer Inc. recently shared positive data from its Phase 2 study examining Clostridium difficile (C. difficile) vaccine candidate, PF-06425090, a product created to help prevent C. difficile infection (CDI), which can include life-threatening diarrhea and pseudomembranous colitis. Read More »
Pfizer Inc. recently announced that its Xeljanz drug for treating moderate to severe active rheumatoid arthritis (RA) has received a positive opinion from the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA). Read More »
GSK has submitted a supplemental Biologics License Application for Fluarix Quadrivalent (influenza vaccine) to the U.S. Food and Drug Administration. Read More »
Pfizer Inc. and EMD Serono, Merck KHaA’s biopharmaceutical arm in the United States and Canada, recently announced that Bavencio was approved by the Food and Drug Administration for intravenous use. Read More »
Diplomat Pharmacy Inc. is now filling prescriptions for KEVZARA (sarilumab), an FDA-approved medication for the treatment of moderate-to-severe rheumatoid arthritis (RA) in patients who are intolerant to or not receiving enough of a response from other disease modifying antirheumatic drugs. Read More »
Alerts Sign-up
