Idorsia Ltd announced positive top-line results of the second pivotal Phase III study investigating 10 and 25 mg doses of its dual orexin receptor antagonist, daridorexant , in… read more.
Atox Bio announced results from the randomized, double-blind, placebo-controlled Phase III ACCUTE (AB103 Clinical Composite endpoint StUdy in Necrotizing Soft Tissue infEctions) trial of reltecimod for the early… read more.
Verrica Pharmaceuticals Inc. announced that the Company received a letter from the FDA as part of the FDA’s ongoing review of the Company’s New Drug Application (NDA) for… read more.
LEO Pharma A/S, a global leader in medical dermatology, announced that the Biologics License Application (BLA) for tralokinumab for the treatment of adults with moderate-to-severe atopic dermatitis (AD)… read more.
Osmotica Pharmaceuticals plc, a fully integrated biopharmaceutical company, announced that the FDA has approved Upneeq (oxymetazoline hydrochloride ophthalmic solution), 0.1%, formerly known as RVL-1201, its novel treatment for… read more.
The Phase III study FIDELIO-DKD evaluating the efficacy and safety of BAY 94 8862 (finerenone), from Bayer, versus placebo when added to standard of care for chronic kidney… read more.
ObsEva SA announced top-line results from the PRIMROSE 1 and 2 studies of Yselty (linzagolix) to assess the efficacy and safety in women with heavy menstrual bleeding due… read more.
Gilead Sciences, Inc. announced additional data on remdesivir, an investigational antiviral for the treatment of COVID-19, adding to the available body of knowledge on treatment outcomes with remdesivir…. read more.
AstraZeneca announced the FDA has accepted a supplemental New Drug Application (sNDA) and granted Priority Review for Brilinta (ticagrelor) for the reduction of subsequent stroke in patients who… read more.
Eisai Co., Ltd. and Merck & Co., Inc., announced that the FDA has issued a Complete Response Letter (CRL) regarding Eisai’s and Merck’s applications seeking accelerated approval of… read more.
Merck Inc announced that the FDA has accepted and granted priority review for a new supplemental Biologics License Application (sBLA) for Keytruda (pembrolizumab), as monotherapy for the treatment… read more.
ChemoCentryx, Inc. confirmed that the Company has submitted a New Drug Application (NDA) to the FDA for avacopan for the treatment of patients with ANCA-associated vasculitis. The Company’s… read more.
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