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FDA+ channel feed
KalVista says FDA delayed decision on HAE drug, citing ‘heavy workload’
Yesterday
Pharma
FDA's oncology adcomm to review GSK's Blenrep relaunch plans
Yesterday
Pharma
Another round of consolidation is coming, FDA commissioner tells staff
Yesterday
People
Moderna wins expanded label for RSV shot, allowing use in at-risk, younger adults
2 days ago
Pharma
Kennedy's vaccine doubts hinge on 'inert' placebos, but experts say he misunderstands the science
2 days ago
Pharma
In surprise, FDA approves UroGen's chemo-turned-gel drug after negative adcomm vote
2 days ago
Pharma
Exclusive: Kennedy picks for vaccine advisory board were paid experts against Merck in civil cases
2 days ago
R&D
Pharma
RFK Jr. names eight new ACIP members, including popular vaccine critic Robert Malone
3 days ago
Pharma
House appropriators call for FDA tweaks on accelerated approvals, biosimilars
3 days ago
R&D
Nuvation Bio scores first FDA approval for new lung cancer drug
3 days ago
Pharma
FDA’s Makary says he wasn’t part of decision to gut ACIP, defers possible VRBPAC changes to Prasad
4 days ago
R&D
Pharma
FDA places hold on Gilead's studies of HIV treatment pill combo
4 days ago
R&D
Updated: HHS chief Kennedy removes all ACIP members, dismantling vaccine board
5 days ago
Pharma
FDA reinstates generic drug policy group let go in April firings
5 days ago
Former HHS lawyer on Novavax delay: Mixing politics and approvals 'imperils' public health
5 days ago
FDA adds biomarker limits to stomach, esophageal cancer labels for Merck's Keytruda and BMS' Opdivo
5 days ago
Pharma
Updated: Merck wins FDA approval for RSV antibody drug, making a hot market more competitive
5 days ago
R&D
Pharma
EMA considers serious eye condition a ‘very rare’ side effect of semaglutide
Last week
Pharma
FDA's Makary looks at ways to speed drug approvals, talks about cutting user fees
Last week
Cell/Gene Tx
Trump's health appointees pledge support for cell and gene therapies at FDA roundtable
Last week
Cell/Gene Tx
FDA's Prasad explains rationale behind pausing Valneva's chikungunya vaccine in seniors
Last week
In a first, Sarepta announces platform technology designation for gene therapy vector
Last week
Cell/Gene Tx
New CBER chief Prasad promises to 'rapidly' push even small advances for rare disease drugs
Last week
FDA's 2026 budget plan seeks to shrink overall funds, but increase user fees
Last week
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