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.
Eisai Co., Ltd. has announced that it has submitted a marketing authorization application in Japan for the EZH2 inhibitor tazemetostat hydrobromide (generic name, development code: E7438, “tazemetostat”) for… read more.
Biogen has completed the submission of a Biologics License Application (BLA) to the FDA for the approval of BIIB 037 (aducanumab) an investigational treatment for Alzheimer’s disease. The… read more.
Aldeyra Therapeutics, Inc. announced development plans to support a New Drug Application (NDA) for the novel investigational reactive aldehyde species (RASP) inhibitor reproxalap in dry eye disease …. read more.
Mallinckrodt Plc ,announced that the Cardiovascular And Renal Drugs Advisory Committee of the FDA will, as expected, hold a virtual meeting to review data on terlipressin, an investigational… read more.
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