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 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.
Results of a global survey of 1,375 adults aged at least 45 years old and living with Chronic Obstructive Pulmonary Disease (COPD) in 11 countries have been published… read more.
LEO Pharma A/S, a global leader in medical dermatology, announced that the Biologics License Application (BLA) for tralokinumab for the treatment of adults with moderate-to-severe atopic dermatitis (AD)… 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.
The Phase III study FIDELIO-DKD evaluating the efficacy and safety of BAY 94 8862 (finerenone), from Bayer, versus placebo when added to standard of care for chronic kidney… 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.
UCB and Ferring Pharmaceuticals Inc. announced they have entered into a co-promotion agreement to commercialize the prefilled syringe formulation of Cimzia (certolizumab pegol) in the United States, specifically… read more.
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.
Gilead Sciences, Inc. announced data demonstrating the safety and efficacy of the once-daily, single tablet regimen Biktarvy (bictegravir 50 mg/emtricitabine 200 mg/tenofovir alafenamide 25 mg tablets, B/F/TAF) in… 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.
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.
Mundipharma announces that the European Commission (EC) has approved the extension of the indication of Invokana (canagliflozin) to include important renal outcome data from the landmark Canagliflozin and… read more.