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BrainStorm Cell Therapeutics received an FDA refusal to file letter for NurOwn — the FDA’s third negative reaction to the investigational treatment — an autologous stem cell therapy aimed at promoting new nerve growth in patients with amyotrophic lateral sclerosis (ALS). Read More
In an 8-5 split, the members of the FDA’s Pulmonary-Allergy Drugs Advisory Committee voted yesterday against an emergency use authorization (EUA) for VERU-11 (sabizabulin) for treatment of COVID-19 at patients at high risk for acute respiratory syndrome which occurs when fluid builds up in the lungs. Read More
AbbVie is seeking EMA marketing authorization for epcoritamab for treating patients with relapsed/refractory diffuse large B-cell lymphoma after two or more lines of systemic therapy. Read More
The FDA has declined to green-light Gilead Sciences’ hepatitis delta virus (HDV) drug bulevirtide because of manufacturing and delivery concerns, meaning there will continue to be no approved treatment for the condition in the U.S. Read More