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. 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.
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. 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.
Gilead Sciences, Inc. announced data demonstrating the safety and efficacy of the once-daily, single tablet regimen Biktarvy (bictegravir 50 mg/emtricitabine 200 mg/tenofovir alafenamide 25 mg tablets, B/F/TAF) in… 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.
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.
Mundipharma announces that the European Commission (EC) has approved the extension of the indication of Invokana (canagliflozin) to include important renal outcome data from the landmark Canagliflozin and… read more.
Akebia Therapeutics, Inc.announced the first regulatory approval of vadadustat, its oral hypoxia-inducible factor prolyl hydroxylase inhibitor (HIF-PHI), for the treatment of anemia due to chronic kidney disease (CKD)…. read more.
BD (Becton, Dickinson and Company) announced that the FDA granted Emergency Use Authorization (EUA) for a rapid, point-of-care, SARS-CoV-2 diagnostic test for use with its broadly available BD… read more.
Regeneron Pharmaceuticals, Inc. announced the initiation of late-stage clinical trials evaluating REGN-COV2, Regeneron’s investigational double antibody cocktail for the treatment and prevention of COVID-19 . A Phase III… read more.
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