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Gilead presents additional data on investigational antiviral remdesivir for the treatment of COVID-19.

Written by | 11 Jul 2020

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.

FDA accepts an sNDA for Brilinta for the reduction of subsequent stroke in patients who experienced an acute ischemic stroke or transient ischemic attack.-AstraZeneca .

Written by | 10 Jul 2020

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.

Complete Response from FDA for Keytruda + Lenvima combination to treat hepatocellular carcinoma ( Liver Cancer)- Merck Inc. + Eisai

Written by | 10 Jul 2020

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.

FDA grants priority review to Keytruda in Hodgkin lymphoma.- Merck Inc

Written by | 10 Jul 2020

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. has submitted a NDA to the FDA for avacopan for the treatment of patients with ANCA-associated vasculitis.

Written by | 10 Jul 2020

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 submitted a marketing authorization application in Japan for the EZH2 inhibitor tazemetostat hydrobromide for EZH2 gene mutation-positive follicular lymphoma.

Written by | 10 Jul 2020

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.

BIIB 037 filed with FDA for Alzheimer’s disease.- Biogen

Written by | 9 Jul 2020

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 development plans for an NDA for reproxalap in dry eye disease.

Written by | 8 Jul 2020

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.

Advisory Committee to meet to review data for terlipressin to treat hepatorenal syndrome.- Mallinckrodt

Written by | 8 Jul 2020

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 initiates phase III trial of REGN-COV2 to treat and prevent Covid-19

Written by | 7 Jul 2020

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.

Approval of vadadustat as Vafseo in Japan for the treatment of anemia due to chronic kidney disease.- Mitsubishi Tanabe + Akebia

Written by | 7 Jul 2020

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 launches portable, rapid point-of-care antigen test to detect SARS-CoV-2 in 15 minutes, dramatically expanding access to COVID-19 testing.

Written by | 7 Jul 2020

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.

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