Regulatory
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.
An FDA advisory committee on Tuesday overwhelmingly rejected Lykos Therapeutics’ investigational MDMA-assisted therapy for post-traumatic stress disorder due to safety concerns and how the company conducted its trials.
Illumina on Monday announced that its board of directors is spinning off Grail and has applied to list the cancer diagnostics company on the Nasdaq.
Regeneron and Sanofi will have to wait until September 2024 for the FDA to decide whether to expand Dupixent’s label to include uncontrolled chronic obstructive pulmonary disease.
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