News

ImmunityBio: Getting Whiplash After FDA's Refusal To File For Anktiva's sBLA
ImmunityBio, Inc.'s FDA rejection for ANKTIVA impacts IBRX shares. Explore the market reaction, potential catalysts, and ...
FDA to undo some layoffs, after cuts to inspections and drug safety
Multiple current and laid-off FDA employees said the abrupt layoffs had resulted in delays and disruptions to the agency's ...
FDA Chief Says He Won’t Reorganize Agency After Mass Layoffs (1)
The FDA doesn’t plan to execute a reorganization of the agency but will consolidate offices that handle travel, technology, ...
Fierce Biotech12d
Vanda sues FDA over hearing delay as agency points to mass layoffs, other litigation with the biopharma
Vanda Pharmaceuticals is suing the FDA again, this time alleging the agency is unlawfully delaying a hearing to discuss the ...
Health Affairs5dOpinion
Purge And Consolidation At FDA: Snatching Defeat From The Jaws Of Victory
The idea of a purge followed by a blender is new, but the idea of a ‘supercenter’ isn’t. Back in 1982, FDA’s Bureau of Drugs ...
FDA Seeks Staff Volunteers to Replace Recently Laid-Off Workers
The FDA’s drug center is asking its staff for volunteers to help out with contract and acquisition requests after the health ...
Physician's Weekly18h
Has FDA’s Drug Development Tools Qualification Program Improved Drug Development?
Qualification program creates a pathway to evaluate Clinical Outcome Assessments (COAs) that capture a specific concept of interest (COI) in a specified Context of Use (COU). If successfully qualified ...
BioSpace7d
Cell and Gene Therapy Sector Enters ‘Critical’ Period After Marks’ FDA Exit
As tariffs, HHS workforce cuts and the ouster of CBER Director Peter Marks threaten the “lifeblood” of the cell and gene ...
FDA Bureaucrats Unlawfully Delay Hearing on Vanda Drug and Falsely Blame Commissioner Makary and the reductions in force at FDA
Vanda Pharmaceuticals Inc. ("Vanda") (Nasdaq: VNDA) today announced that FDA bureaucrats have committed to delay Vanda's ...
ImmunityBio Slapped With FDA Refusal To File Letter For Expanded Use Of Its Bladder Cancer Drug
ImmunityBio's ANKTIVA sBLA for papillary bladder cancer was rejected by the FDA despite prior support, prompting the company to request urgent talks.
Med Device Online11d
FDA RIFs Might Delay Your Review — Here Are Tips For Mitigating
Mounting concerns that FDA reviewers could start missing PDUFA deadlines have put many on edge. The moment calls for ...