Approvals
Based on promising response data from the Phase I/II TRIDENT-1 study, the FDA on Thursday granted Bristol Myers Squibb’s Augtyro accelerated approval for NTRK-positive locally advanced or metastatic solid tumors.
Ipsen and Genfit’s elafibranor will now be marketed as Iqirvo and is the first new medicine approved in nearly a decade for the treatment of the rare liver disease, according to the companies.
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.
Approved for patients with low- to intermediate-risk myelodysplastic syndromes, Geron’s Rytelo is the first telomerase inhibitor to hit the market and the company’s first approved drug after 34 years in business.
Tris Pharma on Wednesday secured the FDA’s green light for Onyda XR, the first liquid non-stimulant nighttime treatment for attention deficit hyperactivity disorder in pediatric patients.
In the next two weeks, the FDA is scheduled to decide on four drug applications and hold two highly anticipated advisory committee meetings.
Amgen on Tuesday secured the FDA’s green light for the first interchangeable biosimilar to AstraZeneca’s Soliris to treat two rare diseases: paroxysmal nocturnal hemoglobinuria and atypical hemolytic uremic syndrome.
The regulator on Monday approved two interchangeable biosimilars to Regeneron’s Eylea, providing additional competition for the pharma’s blockbuster as key patent protections are set to expire.
Bolstered by promising response data from its Phase II study, Amgen announced Thursday it got the FDA’s green light for its first-in-class bi-specific T-cell engager Imdelltra for extensive-stage small lung cancer.
Following back-to-back approvals in lymphocytic leukemia, Bristol Myers Squibb’s CAR-T therapy Breyanzi on Wednesday won the FDA’s green light for relapsed or refractory follicular lymphoma.
PRESS RELEASES