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.
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.
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.
Myovant Sciences announced the presentation of additional data from clinical studies of its once-daily relugolix combination therapy (relugolix 40 mg plus estradiol 1.0 mg and norethindrone acetate 0.5… read more.
ViiV Healthcare, announced positive initial findings from the CUSTOMIZE trial (Cabotegravir plus Rilpivirine in the US To Optimize and Measure Implementation and Experience) which aims to identify successful… read more.
Boehringer Ingelheim have announced the results of a sub-group analysis from the CAROLINA cardiovascular outcome trial focusing on Asian adults with type 2 diabetes mellitus and elevated cardiovascular… read more.
Gilead Sciences, Inc.announced that the European Commission has granted conditional marketing authorization for Veklury (remdesivir) as a treatment for SARS-CoV-2 infection, the virus that causes COVID-19. The conditional… read more.
Acacia Pharma announced that the FDA has approved Byfavo (remimazolam) for injection for the induction and maintenance of procedural sedation in adults undergoing procedures lasting 30 minutes or… read more.
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