New chief at EU drug watchdog
The European Medicines Agency will welcome a new Executive Director by the end of 2020. The change comes as the EU drug watchdog’s current chief, Guido Rasi, is… read more.
The latest coronavirus developments and scientific research on prevention and treatment.
The European Medicines Agency will welcome a new Executive Director by the end of 2020. The change comes as the EU drug watchdog’s current chief, Guido Rasi, is… read more.
Verrica Pharmaceuticals Inc. announced that the Company received a letter from the FDA as part of the FDA’s ongoing review of the Company’s New Drug Application (NDA) for… read more.
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.
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.
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.
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.
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.
Sanofi and Regeneron Pharmaceuticals, Inc. announced that the . Phase III trial of Kevzara (sarilumab) 400 mg in COVID-19 patients requiring mechanical ventilation did not meet its primary… read more.
Pfizer and BioNTech announced preliminary data from the most advanced of four investigational vaccine candidates from their BNT 162 mRNA-based vaccine program, Project Lightspeed, against SARS-CoV-2. The BNT… read more.
Inovio has announced positive interim clinical data of INO 4800 vaccine candidate against novel coronavirus (SARS-CoV-2), from the first two Phase I clinical trial cohorts. In addition, INO… read more.
RedHill Biopharma Ltd. announced that the UK Medicines & Healthcare products Regulatory Agency (MHRA) has approved the Company’s Clinical Trial Authorization application to commence a Phase II/III study… read more.
The EU Committee for Medicinal Products for Human Use has adopted a positive opinion, recommending the granting of a conditional marketing authorisation for the medicinal product Veklury (remdesivir),… read more.
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