Amryt Pharma said on February 28 the U.S. Food and Drug Administration declined to approve the company’s drug for the treatment of a group of rare skin diseases called epidermolysis bullosa.
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.
Lilly and Roche expressed their criticism of the draft guidance from the U.S. Centers for Medicare & Medicaid Services (CMS) for Biogen’s Alzheimer’s drug Aduhelm (aducanumab).
Ardelyx reported in a regulatory filing that the U.S. Food and Drug Administration sent an Appeal Denied Letter (ADL) for the company’s drug tenapanor, a therapeutic intended for chronic kidney disease.
Rivus Pharmaceuticals, a biopharma company focused on therapies for cardiometabolic health, announced positive data from a Phase IIa clinical trial.
New York-based Ovid Therapeutics and Healx entered a strategic partnership to investigate the compound gaboxadol to treat Fragile X Syndrome (FXS).
A new study by the American Stroke Association found that the risk of stroke in adults with COVID-19 between the ages of 65 to 74 was highest the first three days after diagnosis. Additionally, investigators at the National Institutes of Allergy and Infectious Diseases’ Vaccine Research Center ran tests on primates and found that updating COVID-19 vaccines to focus on the Omicron variant may not provide much benefit.
Gaithersburg, Maryland-based Altimmune announced that the U.S. Food and Drug Administration cleared a Phase II clinical trial for the biopharmaceutical company’s investigational obesity-treating drug pemvidutide.
The U.S. Food and Drug Administration issued a Complete Response Letter to Chicago’s Levo Therapeutics for the company’s New Drug Application for LV-101, which is being developed as a treatment for hyperphagia (excessive overeating), anxiousness and distress associated with Prader-Willi syndrome (PWS).
Gilead Sciences Inc. on Jan. 14 notified the U.S. health regulator of the company’s decision to voluntarily withdraw the use of the drug Zydelig for two types of cancer – follicular lymphoma and small lymphocytic leukemia.
