FDA
Ahead of the Inflation Reduction Act’s drug price negotiations, the regulator has approved Amgen’s biosimilar challenge to Johnson & Johnson’s Stelara—with an interchangeable designation to boot.
FEATURED STORIES
One of the FDA’s potential approvals this month could break an existing monopoly in the treatment space for a rare growth disorder.
After a leading study caused the FDA to slap its most stringent warning on hormone replacement therapies for menopause more than two decades ago, the regulator is changing course in what FDA Commissioner Marty Makary called a “historic day for women in the United States.”
The upheaval of the Health and Human Services workforce and leadership leaves much to be desired in terms of delivery, recently retired FDA Chief Information Officer Vid Desai tells BioSpace, but the regulatory agency is evolving to be more open to much needed change.
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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.
AbbVie and Genmab announced positive topline results from their Phase I/II trial for lymphoma treatment; Sanofi posted positive results from its Phase I/II trial for the treatment of ITP.
Pfizer and BioNTech will submit updated data to the FDA to support the Emergency Use Authorization (EUA) of COVID-19 vaccination boosters in children between the age of 5 and 11.