FDA
The FDA greenlit Libtayo plus chemotherapy to treat patients with advanced NSCLC irrespective of EGFR, ALK or ROS1 aberrations. It is the drug’s second approval in this space.
A request for additional data may cause a 3-month delay for potential approval of BioMarin Pharmaceutical’s hemophilia A gene therapy.
An FDA adcomm that met Wednesday to vote on GlaxoSmithKline’s daprodustat for adult patients with anemia due to chronic kidney disease (CKD) produced mixed results.
The FDA has greenlit the use of Johnson & Johnson’s Tecvayli in heavily pretreated adult patients with relapsed or refractory multiple myeloma.
The FDA greenlit AstraZeneca’s tremelimumab in combination with its checkpoint inhibitor Imfinzi as a treatment for patients with unresectable hepatocellular carcinoma.
The FDA released guidelines Thursday in an attempt to clarify processes for assessing a drug candidate’s efficacy while examining several endpoints, simultaneously.
On Friday, the FDA approved Boostrix, a vaccine administered during the third trimester of pregnancy to prevent pertussis in infants under 2 months of age.
The FDA had a fairly quiet week, approving drugs, providing clearance, greenlighting clinical trials, and other regulatory activities for Alnylam, Eli Lilly, Cytokinetics, and more.
The FDA approved Alnylam’s Oxlumo for an expanded indication, rare disease PH1, with the label to include patients with the most severe kidney impairment.
The biopharma world - and markets - spent Thursday evening reacting after the FDA gave the green light to only its third-ever drug for ALS, Amylyx’s Relyvrio.
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