Pfizer Inc. and BioNTech SE announced that the first participants have been dosed in the U.S. in the Phase 1/II clinical trial for the BNT 162 vaccine program… read more.
Akebia Therapeutics announced positive top-line results from INNO2VATE, its global Phase III cardiovascular outcomes program evaluating the efficacy and safety of AKB 6548 (vadadustat), its investigational oral hypoxia-inducible… read more.
Pfizer Inc. announced detailed results of the first study to show the burden of both invasive and non-invasive Group B Streptococcus infections (GBS) among hospitalized adults in the… read more.
Topline data for a pivotal, single-arm, open-label trial for Sanofi and Regeneron’s PD-1 inhibitor Libtayo (cemiplimab) in patients with advanced basal cell carcinoma (BCC) who had progressed on… read more.
Roche announced that the FDA has issued an Emergency Use Authorization (EUA) for its new Elecsys Anti-SARS-CoV-2 antibody test. The test is designed to help determine if a… 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 Cabazitaxel Accord (cabazitaxel), from… read more.
Gilead Sciences, Inc. announced that the FDA has granted emergency use authorization (EUA) for the investigational antiviral remdesivir to treat COVID-19. The EUA will facilitate broader use of… read more.
EMA’s human medicines committee (CHMP) has started a ‘rolling review’ of data on the use of the investigational antiviral medicine remdesivir for the treatment of coronavirus disease (COVID-19)…. read more.
Blueprint Medicines Corporation , a precision therapy company focused on genomically defined cancers, rare diseases and cancer immunotherapy, announced top-line results from the Phase III VOYAGER clinical trial… read more.
The Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion recommending a change to the terms of the marketing authorisation for the medicinal product Braftovi…. read more.
Bristol Myers Squibb announced that the FDA has accepted its New Drug Application (NDA) for CC 486, an investigational oral hypomethylating agent, for the maintenance treatment of adult… 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 Insulin aspart Sanofi, intended… read more.
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