AbbVie and Gedeon Richter signed an agreement to co-develop and commercialize a potential treatment for a range of neuropsychiatric diseases.
Sanofi and partner Swedish Orphan Biovitrum shared positive topline results from their ongoing Phase III trial on a candidate drug for patients diagnosed with severe hemophilia A.
Valneva is advancing toward U.S. FDA accelerated approval of the France-based biologics company’s VLA1553 after the specialty vaccine was shown to be safe and effective against mosquito-transmitted chikungunya disease, in a published analysis of Phase III results.
OptiNose AS, which focuses on treating ear, nose and throat (ENT) and allergy diseases, announced that the Pennsylvania-based pharmaceutical company’s Phase III ReOpen1 clinical trial met both co-primary endpoints.
A late-stage study of Gilead Sciences’ antibody-drug conjugate Trodelvy shows promise in slowing disease progression in some of the most common forms of breast cancer.
Less than a year after a regulatory setback, Acadia Pharmaceuticals resubmitted the company’s supplemental New Drug Application for Nuplazid (pimavanserin) as a potential treatment for hallucinations and delusions associated with dementia-related psychosis.
The U.S. Food and Drug Administration held a joint meeting of the Anesthetic and Analgesic Drug Products Advisory Committee and the Drug Safety and Risk Management Advisory Committee on Avenue Therapeutics’ IV tramadol.
The Food and Drug Administration’s Oncologic Drugs Advisory Committee (ODAC) recommended that Eli Lilly and Co. and Innovent Biologics Inc. conduct a clinical trial applicable to the U.S. population for the lung cancer drug sintilimab. The U.S. FDA previously raised concerns over a clinical trial conducted entirely in China focused on a single ethnic group.
The U.S. Food and Drug Administration approved Sanofi’s proposed drug to address red blood cell destruction in patients living with a rare form of anemia called cold agglutinin disease (CAD).
Belgium-based UCB hit the mark in the company’s Phase III clinical trial assessing zilucoplan as a potential treatment for adults with generalized myasthenia gravis, a rare autoimmune disease. Vanda Pharmaceuticals’ late-stage study of tradipitant as a treatment for the symptoms of gastroparesis, a digestive disorder, failed to meet the trial’s primary endpoint.
