Novoteris LLC's Phase 2 clinical trial application for inhaled nitric oxide as a treatment for cystic fibrosis has been approved by both the U.S. Food and Drug Administration and the Therapeutic Products Directorate of Health Canada. Read More »
Pfizer Inc. recently announced that the U.S. Food and Drug Administration (FDA) accepted the company’s supplemental New Drug Application (sNDA) for Sutent. Read More »
HedgePath Pharmaceuticals Inc. (HPPI) recently announced that the U.S. Food and Drug Administration (FDA) granted the company’s Type-C Guidance Meeting Request for further guidance on HPPI’s Phase 2(b) clinical trial analyzing SUBA-Itraconazole (SUBA-Cap) oral capsule usage in patients with Basal Cell Carcinoma Nevus Syndrome (BCCNS), also known as Gorlin Syndrome. Read More »
Sunovion Pharmaceuticals Inc.'s supplemental New Drug Application for a medication addressing bipolar conditions has won acceptance for review by the U.S. Food and Drug Administration. Read More »
Endo International plc has voluntarily opted to withdraw its Opana ER (oxymorphone hydrochloride extended release) product from the market after an FDA request in June, following a thorough review period and collaboration with the agency. Read More »
Meridian Bioscience Inc. released comments on a recent Food and Drug Administration Safety Notification concerning Magellan Diagnostics. Read More »
KaloBios Pharmaceuticals Inc. of California, specializing in rare and neglected diseases, recently obtained FDA clearance for its oral anti-parasitic medication benznidazole designed to combat Chagas disease, a tropical malady transmitted to humans by insects. Read More »
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 »
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