Regulatory
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.
Arcturus Therapeutics announced positive Phase III trial results for its mRNA vaccine candidate, ARCT-154, intended to prevent COVID-19 caused by the SARS-CoV-2 virus.
Gilead Sciences scored a legal victory regarding fraudulent HIV reimbursements, securing a court order against a number of clinics, labs and prescribers in Florida that were engaging in the alleged fraud.
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.
Pharma giant Moderna has shared data on the development of a new bivalent COVID-19 booster vaccine that performs better than its first booster that is currently on the market.
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).
McKinsey & Company is under fire for allegedly allowing its employees to work simultaneously for big pharma companies and serve as consultants for the U.S. Food and Drug Administration.
The SEC added 12 China companies to their delisting watchlist this week. The companies will need to release evidence by May 3 to remain listed.
The FDA issued new guidance urging drugmakers to submit racial and minority recruitment plans when designing their studies.
PRESS RELEASES