AstraZeneca’s Alexion received a supplemental New Drug Application approval for Ultomiris (ravulizumab-cwvz) from the U.S. Food and Drug Administration to treat adults with generalized myasthenia gravis (gMG).
Neurocrine Biosciences announced positive results from the company’s Phase III KINECT-HD study evaluating the efficacy of valbenazine in the treatment of chorea associated with Huntington’s Disease (HD).
After Karyopharm Therapeutics Inc. submitted Phase III data from the Massachusetts-based pharmaceutical company’s SIENDO study on selinexor, the U.S. Food and Drug Administration said it was unlikely to support a supplemental New Drug Application approval for the drug.
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 granted full approval of Genentech’s Venclexta (venetoclax) in combination with azacitidine, or decitabine or low-dose cytarabine for the treatment of newly diagnosed acute myeloid leukemia (AML) in adults 75 years or older, or who have comorbidities that preclude use of intensive induction chemotherapy.
The U.S. Food and Drug Administration approved a supplemental New Drug Application for Shionogi & Co. Ltd.’s Fetroja (cefiderocol) for the treatment of patients 18 years of age or older with hospital-acquired bacterial pneumonia and ventilator-associated bacterial pneumonia (HABP/VABP).
The U.S. Food and Drug Administration approved a new indication for GlaxoSmithKline plc and Innoviva Inc.’s Trelegy Ellipta (fluticasone furoate/umeclidinium/vilanterol ‘FF/UMEC/VI’) for the treatment of asthma in patients aged 18 years and older adding to the product’s current license for use in patients with chronic obstructive pulmonary disease (COPD).
The U.S. Food and Drug Administration accepted Acadia Pharmaceuticals Inc.’s application for an antipsychotic drug to treat dementia patients with hallucinations and delusions.
Wrapping up June and ahead of the July 4 holiday, the U.S. Food and Drug Administration has a busy two-week period coming up for drug approval reviews.
Shares of Epizyme stock rose after the company’s first-in-class EZH2 inhibitor Tazverik won approval from the U.S. Food and Drug Administration for the second time in 2020.