Progressive women's health care company Agile Therapeutics Inc. of Princeton, New Jersey has resubmitted its Twirla hormonal contraceptive patch to the U.S. Food and Drug Administration for a New Drug Application. 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 »
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 »
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 »
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 »
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 »
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 »
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 »
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 »
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 »
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 »
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 »
A prescription chemotherapy drug manufactured by Florida-based Breckenridge Pharmaceutical Inc. has earned Food and Drug Administration approval, moving a step closer to combating a rare type of blood and bone marrow cancer. Read More »
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 »
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