Approvals
The U.S. FDA has a busy period at the end of October heading into the first week of November.
Lexington, Mass.-based Agenus withdrew its Biologics License Application for balstilimab from the U.S. FDA. The drug is a PD-1 inhibitor or checkpoint inhibitor.
The FDA placed a clinical hold on Tryp Therapeutics’ Phase IIa trial for eating disorders, including binge eating disorder and hypothalamic obesity.
The U.S. FDA approved the use of Moderna’s and Janssen’s COVID-19 vaccines as a booster dose after their primary versions are completed.
Zimhi is indicated for use in both adults and children in the event of an emergency. It is to be given right away and does not take the place of emergency care.
Omeros Corporation shares were down in premarket trading after the company received a CRL for its experimental hematopoietic stem cell transplant-associated thrombotic microangiopathy treatment.
The FDA reviewed Tecentriq under Project Orbis, allowing the simultaneous submission and review of potential oncology treatments to international regulatory bodies.
The FDA and Regeneron are reportedly in talks to set up an advisory committee meeting to discuss the BLA ahead of the target action date.
The news of a unanimous decision by the adcom came just two days after the agency issued a 45-page document that contained vague comments on the drug.
The FDA gave Ardelyx a CRL on the NDA but did not mention anything about clinical pharmacology or biopharmaceutics, safety, or any related non-clinical concerns.
PRESS RELEASES