FDA
The FDA on Friday approved GSK’s application to use Arexvy to vaccinate adults aged 50 to 59 years who are at increased risk of developing severe respiratory syncytial virus.
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After a leading study caused the FDA to slap its most stringent warning on hormone replacement therapies for menopause more than two decades ago, the regulator is changing course in what FDA Commissioner Marty Makary called a “historic day for women in the United States.”
The upheaval of the Health and Human Services workforce and leadership leaves much to be desired in terms of delivery, recently retired FDA Chief Information Officer Vid Desai tells BioSpace, but the regulatory agency is evolving to be more open to much needed change.
While the FDA continues to put out guidance documents and approve drugs, some companies are already reporting delays in dealings with the agency, while insiders warn of falling morale and a negative perception from the rest of the biopharma world.
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Otsuka and Lundbeck won approval Friday for Abilify Asimtufii, a long-acting injectable that provides two months of symptom relief in patients with schizophrenia or bipolar I disorder.
Prevnar 20 is indicated for the prevention of invasive pneumococcal disease and otitis media in children.
Vowst, the first-ever oral fecal microbiome-based therapeutic, is indicated for preventing C. diff recurrence in adults following antibacterial treatment.
Govorestat failed its primary composite measure but showed signals of efficacy, leading the company to push forward with an NDA.
To give the FDA more time to evaluate updates to quizartinib’s proposed REMS program, the regulator is pushing the target action date to July 24.
The FDA’s Center for Biologics Evaluation and Research is aiming to recreate the success achieved with the rapid development of COVID-19 vaccines under a program of the same name.
This week, the FDA will release its verdict on Biogen and Ionis’ ALS candidate tofersen and three other investigational medicines for psychiatric disorders, hormonal insufficiency and gut infection.
Polivy is approved for front-line DLBCL as part of a combination regimen including Rituxan, cyclophosphamide, doxorubicin and prednisone.
Qulipta’s label expansion makes it the first oral CGRP receptor antagonist approved for episodic and chronic migraine.
Omisirge is approved for patients who receive cord blood transplantation following myeloablative therapy.