Heron Therapeutics, Inc. announced that it received a Complete Response Letter (CRL) from the FDA on June 26, 2020 regarding its New Drug Application (NDA) for HTX 011… read more.
Intercept Pharmaceuticals, Inc. announced that the FDA has issued a Complete Response Letter (CRL) regarding the New Drug Application (NDA) for obeticholic acid (OCA) for the treatment of… read more.
Cancer Prevention Pharmaceuticals has submitted a New Drug Application (NDA) to the FDA seeking accelerated approval for CPP 1X/sul for treatment of adults with familial adenomatous polyposis (FAP)…. read more.
Kiniksa Pharmaceuticals announced that the Phase III RHAPSODY trial showed that rilonacept achieved its primary and all major secondary efficacy endpoints in patients with recurrent pericarditis. Results show… read more.
Iterum Therapeutics announced topline results from its phase III SURE 1 clinical trial of sulopenem for the treatment of Uncomplicated Urinary Tract Infections (uUTI). Sulopenem is a novel… read more.
Alexion Pharmaceuticals announced that the European Commission has approved Ultomiris (ravulizumab)—the first and only long-acting C5 complement inhibitor administered every eight weeks*—for the treatment of adults and children… read more.
The Janssen Pharmaceutical Companies of Johnson & Johnson announced its decision to discontinue the Phase III LOTUS study of Stelara (ustekinumab) in Systemic Lupus Erythematosus (SLE) due to… read more.
Abbott announced new data from the company’s LightLab Initiative that showed optical coherence tomography (OCT) imaging significantly changes how physicians decide to treat a vessel compared to traditional… read more.
Hansa Biopharma announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion, recommending conditional approval of… read more.
The Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion, recommending the granting of a marketing authorisation for the medicinal product Aybintio, intended for the… read more.
The Committee for Medicinal Products for Human Use adopted a positive opinion, recommending the granting of a marketing authorisation for the medicinal product Qutavina (teriparatide), from EuroGenerics Holdings,… read more.
The Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion, recommending the granting of a marketing authorisation for the medicinal product Gencebok, intended for the… read more.
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