Fda
Top news of August: Tezepelumab breakthrough designation, pitolisant use in OSA
Healio has compiled the most-read news in pulmonology posted in August.
FDA fast tracks CAR T-cell therapy for refractory lupus in anticipation of phase 1 trial
The FDA has granted fast track designation to CB-010, an allogeneic anti-CD19 CAR T-cell therapy from Caribou Biosciences, for refractory systemic lupus erythematosus ahead of a planned phase 1 trial, according to a press release.
FDA clears investigational new drug application for photoreceptor disease therapy
The FDA cleared an investigational new drug application for OpCT-001, an investigational cell therapy for the treatment of primary photoreceptor diseases, according to a press release from BlueRock Therapeutics.
Top in endocrinology: Omnipod 5 for type 2 diabetes; single-dose vials of tirzeptaide
The FDA has cleared a tubeless automated insulin delivery system indicated for adults with type 2 diabetes.
FDA grants emergency use authorization to updated COVID vaccine
The FDA granted emergency use authorization for an updated version of the COVID-19 vaccine manufactured by Novavax that targets the currently circulating Omicron variant JN.1 strain of SARS-CoV-2 virus.
FDA approves new label for Gloperba enabling precision dosing for gout prophylaxis
The FDA has approved an updated label for Gloperba, an oral liquid colchicine formulation, allowing for precision dosing, according to a press release from Scilex Holding Company.
FDA grants fast-track designation to injectable positron emission tomography diagnostic
The FDA has granted fast-track designation to an investigational tau positron emission tomography diagnostic that can be used for a range of neurodegenerative conditions, according to the manufacturer.
Q&A: Yutrepia for PAH, pulmonary hypertension-ILD receives tentative FDA approval
Around 7 months after not meeting the Prescription Drug User Fee Act goal date for Yutrepia, the FDA has tentatively approved the drug for pulmonary arterial hypertension and pulmonary hypertension-associated interstitial lung disease.
FDA clears tubeless automated insulin delivery system for adults with type 2 diabetes
The FDA has cleared an automated insulin delivery system for adults aged 18 years and older with type 2 diabetes, Insulet Corp. announced.
ACR praises FDA plan to end switching study requirement for interchangeable biosimilars
The American College of Rheumatology has applauded an FDA proposal to streamline the approval of interchangeable biosimilars, removing requirements for switching studies to determine their interchangeability with reference products.