Regulatory
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.
Shifts in the FDA’s approach present an unprecedented opportunity to solve problems with patient access and trial design.
The FDA has a packed calendar this week, with six decisions on the docket, including ones for Merck’s Keytruda, BMS’s Krazati and Sarepta’s Elevidys.
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.
After rejecting a previous takeover offer from Future Pak, Vanda Pharmaceuticals is now fielding another acquisition proposal from Cycle Pharmaceuticals, which values the biotech at $8 per share.
In advance of an advisory committee meeting on Monday, the FDA’s internal reviewers have raised issues regarding Eli Lilly’s Alzheimer’s disease candidate donanemab, flagging problems with its study design and safety outcomes.
Moderna on Thursday said its investigational mRNA-based therapy for methylmalonic acidemia has been selected for the FDA’s accelerator program for rare diseases, dubbed START.
Gilead Sciences’ primary biliary cholangitis candidate seladelpar and Ipsen’s PBC asset elafibranor both showed encouraging Phase III results Wednesday, as they face looming FDA decision dates.
The U.K.’s National Institute for Health and Care Excellence has endorsed the use of Eli Lilly’s Zepboundfor weight management in patients with BMI of 35 kg/m2 and above and at least one weight-related comorbidity.
PRESS RELEASES