Approvals
A large number of people were waiting for the breast cancer vaccine. Now, at present, the world has witnessed the first potential vaccine. Let’s take a look at it.
The U.S. Food and Drug Administration posted analyses of the Pfizer-BioNTech COVID-19 vaccine in children ages 5 to 11 years old ahead of Tuesday’s vaccines advisory committee meeting.
Xipere was approved for suprachoroidal use for the macular edema treatment. Macular edema is associated with uveitis, it is a form of eye inflammation.
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.
PRESS RELEASES