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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.
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 ...
Physician's Weekly11h
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 ...
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 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 ...
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 ...
BioSpace11d
Vanda Escalates Vendetta Against FDA, Blasts ‘Bureaucrats’ for Delaying Stomach Drug
The tradipitant saga stretches back to September 2024, when the FDA declined to approve Vanda’s drug in gastroparesis, a ...
STAT14d
Pharmalittle: We’re reading about a Novo challenge to Medicare talks, a scuttled FDA office, and more
Novo Nordisk argues Medicare should negotiate the price for six of its insulin products separately, though they contain the ...
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 ...
Seeking Alpha25d
FDA staff cuts are already impacting regulatory work, Biotech leaders warn
Patrizia Cavazzoni, who served as the FDA’s Director of the Center for Drug Evaluation and Research (CDER) joined as Pfizer’s (NYSE:PFE) Chief Medical Officer in February, while Peter Marks ...
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 ...