News

BioPharma Dive3h
FDA takes major step to ease access to CAR-T therapy
The agency removed some onerous requirements for the complex cancer drugs and reduced restrictions on patients’ ...
The Manila Times1h
Theranos Makes a Big Bang at the FDA
Today marks a significant milestone for theranos and its diagnostic technology. The theranos system performs automated sample ...
FDA probes deaths of boys taking Sarepta Duchenne drug
The FDA said yesterday that it is investigating the deaths from liver failure of two non-ambulatory boys with Duchenne ...
BioSpace1d
Novavax Approval Process a Potential ‘Harbinger’ of Threat to FDA Integrity: Former Regulators
Writing in JAMA, four former government officials warn that the Trump administration’s involvement in delaying the approval ...
MedPage Today22h
Experts Have Questions About FDA's New Priority Review Program
While there's little disagreement that speeding drug approvals would be a good thing, there are more questions than answers ...
Fierce Pharma5h
FDA removes CAR-T access barrier in move set to boost cancer immunotherapy uptake
Restricted availability under an FDA-mandated drug safety program has limited the reach of CAR-T cell therapies for certain blood cancers—until now. | The FDA has removed the REMS requirements for ...
Becker's Hospital Review5h
FDA expands approval of imaging agent to aid Alzheimer’s diagnosis
The FDA has approved expanded use of GE HealthCare’s PET imaging agent, Vizamyl, for improved detection and monitoring of Alzheimer’s disease. The updated label now allows Vizamyl to be used to detect ...
KALW5h
How the FDA allows dangerous generic drugs into US pharmacies
The FDA has allowed more than 20 foreign factories to send drugs to the US even though they were made at plants that the ...