Approvals
A federal judge compelled Merck to release confidential information on its HPV vaccine as a part of discovery in a series of lawsuits spanning states dating back to 2020.
Elfabrio’s label contains a boxed warning for hypersensitivity reactions, such as anaphylaxis, and recommends that medical support measures should be on standby when administering the treatment.
During a first-quarter earnings call, Novo revealed its hemophilia candidate had been blocked by the FDA, and that the company is reducing the U.S. supply of lower doses of weight-loss drug Wegovy.
As the COVID-19 market dries up, Moderna looks to FDA approval of its other vaccines including a 2024 commercial launch of its investigational RSV vaccine for older adults.
The regulatory decision marks a turning point in the RSV race in what’s expected to be a competitive space.
The Oncologic Drugs Advisory Committee voted 11–1 supporting Merck’s and AstraZeneca’s PARP inhibitor for metastatic castration-resistant prostate cancer patients with BRCA mutations.
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.
PRESS RELEASES