Approvals
RMAT designation means a faster, more streamlined approval process and frequent communication with FDA representatives. The FDA recently granted RMAT Designations to both Direct Bio and AlloVir.
The U.S. FDA’s Oncologic Drugs Advisory Committee is holding a meeting on April 21, 2022, to discuss safety findings across the entire class of PI3K inhibitors for hematological cancers.
The FDA has issued a Complete Response Letter (CRL) for TV-46000/mdc-IRM (risperidone extended-release injectable suspension for subcutaneous use) to Teva Pharmaceuticals and MedinCell.
Axsome Therapeutics received good news regarding its NDA for AXS-05, a treatment for depression, and Aytu BioScience received Fast Track designation for its VEDS treatment.
AstraZeneca and Daiichi Sankyo reported that their supplemental Biologics License Application (sBLA) for Enhertu was granted Priority Review by the U.S. Food and Drug Administration.
TG Therapeutics voluntarily withdrew its pending BLA and supplemental NDA for its treatment dubbed U2 for adults with chronic lymphocytic leukemia (CLL) and small lymphocytic lymphoma (SLL).
The U.S.Food and Drug Administration has granted Emergency Use Authorization to a breathalyzer that can detect COVID-19 within three minutes.
Regeneron announced that the U.S. FDA has extended its review of the BLA for monoclonal antibody REGEN-COV, which treats COVID-19.
The FDA issued new guidance urging drugmakers to submit racial and minority recruitment plans when designing their studies.
The FDA granted Merck’s investigational 21-valent pneumococcal conjugate vaccine (V116) for IPD and pneumococcal pneumonia Breakthrough Therapy Designation.
PRESS RELEASES