European committee takes a second look at Alzheimer's drug and now says it should be approved
A European regulatory committee now recommends approval of the Alzheimer’s treatment lecanemab a few months after rejecting ...
medtechdive3h
FDA breakthrough device decisions rebound after recent declines
The FDA designated 166 products under its breakthrough devices program in its most recent financial year, reversing the ...
AZoLifeSciences on MSN5h
The Commercialization Process for Antibody Therapeutics
The rise of antibody therapeutics is transforming drug discovery, providing highly specific treatments for complex diseases ...
Pharmaceutical Technology5h
FDA grants accelerated approval for PTC’s AADC deficiency gene therapy
The US Food and Drug Administration (FDA) has granted accelerated approval for PTC Therapeutics’ KEBILIDI, the first gene ...
Abolish the FDA (opinion)
Many seriously ill people die waiting for the FDA to approve drugs that regulators in other advanced countries have already ...
Reuters21h
US FDA approves PTC Therapeutics' gene therapy for ultra-rare disorder
PTC Therapeutics' gene therapy is already approved in the European Union, Great Britain, and Israel. The drugmaker will also ...
SF Weekly21h
Leen Kawas Details the Factors Behind High Drug Development Costs (and Presents Strategies to Address Them)
She also offered strategies to streamline the process and reduce the strain on the developer ... the drug developer submits ...
News Medical22h
The benefits and challenges of FDA Fast-Track and Accelerated Approval in drug development
Expediting the review process allows for appropriately timed advice and implementing adjustments that considerably reduce the ...
US FDA declines full approval for Intercept's liver disease drug
The U.S. Food and Drug Administration on Tuesday declined full approval for Intercept Pharmaceuticals' liver disease drug, ...
From AI to Musk’s brain chips, the FDA’s device unit faces rapid change
The new director at the FDA overseeing medical devices will confront criticisms about hasty approvals as she ushers in ...
Unicycive: FDA to Review Lead Drug Candidate for Hyperphosphatemia
Unicycive, which is seeking an FDA green light for oxylanthanum carbonate to treat hyperphosphatemia in patients with chronic kidney disease who are on dialysis, Monday said the agency set a target ...