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.
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.
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.
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.
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.
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.
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.
Genmab announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has issued a Positive Opinion recommending the use of the… read more.
Bio-Rad Laboratories announced that it was granted FDA Emergency Use Authorization (EUA) for the company’s SARS-CoV-2 Total Ab test, the first total antibody test receiving EUA from the… read more.
-Bristol Myers Squibb and Acceleron Pharma Inc. announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency has issued a positive opinion,… read more.
Gilead Sciences, Inc. announced topline results from the open-label, Phase III SIMPLE trial evaluating 5-day and 10-day dosing durations of the investigational antiviral remdesivir in hospitalized patients with… read more.
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