Intraocular therapeutics manufacturer Icon Bioscience Inc., focusing on innovative eye care, recently obtained U.S. Food and Drug Administration acceptance of its new drug application for Dexycu, with full approval anticipated in 2018. Read More »

To combat severe pain for which alternative treatments fall short, BioDelivery Sciences International Inc.’s Belbuca (buprenorphine hydrochloride buccal film) product has just gained approval from Canada’s regulatory body, Health Canada, earning its Notice of Compliance. Read More »

Adapt Pharma recently acknowledged the U.S. Drug Enforcement Administration's new guidance rules for first responders related to the hazards of fentanyl exposure. Read More »

Portola Pharmaceuticals recently announced that its Bevyxxa drug was approved by the U.S. Food and Drug Administration (FDA) for treating adult patients hospitalized for an acute medical illness who are at risk for thromboembolic complication. Read More »

The U.S. Patent Office published Citius Pharmaceuticals' patent application for enhanced stability of antimicrobial solutions for locking central venous catheters. Read More »

Rigel Pharmaceuticals Inc. recently announced that its New Drug Application (NDA) for the use of Tavalisse in treating chronic or persistent immune thrombocytopenia (ITP) has been filed by the U.S. Food and Drug Administration (FDA). Read More »

PharmaMar will present clinical data from Phase I and II studies examining Zepsyre’s effect on pediatric cancers and hematological disorders to the Pediatric Oncology Subcommittee of the Oncologic Drugs Advisory Committee of the U.S. Food and Drug Administration. Read More »

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 »