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FDA grants emergency use authorization of remdesivir to treat COVID-19.

Written by | 3 May 2020

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.

Rolling submission at EMA for remdesivir to treat coronavirus disease.- Gilead Sciences

Written by | 3 May 2020

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.

Ayvakit fails to meet primary endpoint in Phase III VOYAGER trial versus regorafenib for gastrointestinal stromal tumor.- Blueprint Medicines Corpn.

Written by | 3 May 2020

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.

CHMP recommends Braftovi + cetuximab for the treatment of adult patients with metastatic colorectal cancer (CRC) with a BRAF V600E mutation.- Pierre Fabre

Written by | 3 May 2020

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.

CC-486 has NDA accepted by FDA for maintenance treatment of adult patients in remission with acute myeloid leukemia.- BMS

Written by | 2 May 2020

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.

CHMP recommends Insulin aspart Sanofi, a biosimilar product, intended for the treatment of diabetes mellitus.- Sanofi

Written by | 2 May 2020

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.

CHMP recommends Daurismo intended for the treatment of acute myeloid leukaemia .- Pfizer

Written by | 2 May 2020

The Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion, recommending the granting of a marketing authorisation for the medicinal product Daurismo intended for the… read more.

CHMP recommends approval of Ultomiris for atypical hemolytic uremic syndrome.- Alexion Pharma

Written by | 2 May 2020

Alexion Pharmaceuticals announced that the Committee for Medicinal Products for Human Use has adopted a positive opinion, recommending marketing authorization in the European Union for Ultomiris (ravulizumab) for… read more.

NIAID Adaptive clinical trial shows remdesivir accelerates recovery from advanced COVID-19.

Written by | 1 May 2020

Hospitalized patients with advanced COVID-19 and lung involvement who received remdesivir recovered faster than similar patients who received placebo, according to a preliminary data analysis from a randomized,… read more.

CHMP recommends Enerzair Breezhaler as a maintenance treatment of asthma in adult patients not adequately controlled with a combination of a long acting beta2 agonist (LABA) and a high dose of an inhaled corticosteroid.- Novartis

Written by | 1 May 2020

Novartis announced that the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion recommending the approval of Enerzair Breezhaler (QVM… read more.

Phase III FLASH trial of SGX 301 shows increased efficacy in T-cell lymphoma.- Soligenix

Written by | 1 May 2020

Soligenix announced that continued treatment with SGX 301 (synthetic hypericin) twice weekly for 12 weeks increased the positive response rate to 40% in the open-label treatment cycle (referred… read more.

FDA guidance for Phase III B-SIMPLE 4 trial of SB 206 to treat molluscum contagiosum.- Novan Inc.

Written by | 1 May 2020

Novan, Inc.has announced that the Company has received meeting minutes from the April 1, 2020 Type C meeting with the FDA regarding SB 206 for the treatment of… read more.

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