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FDA+ channel feed
Inside the FDA’s ‘listening’ tour: Officials agree US lags behind China on drug development
3 weeks ago
R&D
FDA's top cell and gene therapy leaders exit agency in ongoing CBER changes
3 weeks ago
Cell/Gene Tx
Gilead gets groundbreaking FDA approval for twice-yearly HIV prevention shot
3 weeks ago
Pharma
CBER head Prasad adds chief medical and scientific officer to his title
3 weeks ago
Pharma
FDA approves CSL’s prophylactic for severe swelling condition
4 weeks ago
Pharma
FDA unveils one-year pilot to speed some new drugs to market in just one month
4 weeks ago
What's coming in five years? FDA chief points to universal flu vaccine, new approval pathway
4 weeks ago
KalVista says FDA delayed decision on HAE drug, citing ‘heavy workload’
4 weeks ago
Pharma
FDA's oncology adcomm to review GSK's Blenrep relaunch plans
4 weeks ago
Pharma
Another round of consolidation is coming, FDA commissioner tells staff
4 weeks ago
People
Moderna wins expanded label for RSV shot, allowing use in at-risk, younger adults
4 weeks ago
Pharma
Kennedy's vaccine doubts hinge on 'inert' placebos, but experts say he misunderstands the science
4 weeks ago
Pharma
In surprise, FDA approves UroGen's chemo-turned-gel drug after negative adcomm vote
4 weeks ago
Pharma
Exclusive: Kennedy picks for vaccine advisory board were paid experts against Merck in civil cases
4 weeks ago
R&D
Pharma
RFK Jr. names eight new ACIP members, including popular vaccine critic Robert Malone
4 weeks ago
Pharma
House appropriators call for FDA tweaks on accelerated approvals, biosimilars
4 weeks ago
R&D
Nuvation Bio scores first FDA approval for new lung cancer drug
4 weeks ago
Pharma
FDA’s Makary says he wasn’t part of decision to gut ACIP, defers possible VRBPAC changes to Prasad
5 weeks ago
R&D
Pharma
FDA places hold on Gilead's studies of HIV treatment pill combo
5 weeks ago
R&D
Updated: HHS chief Kennedy removes all ACIP members, dismantling vaccine board
5 weeks ago
Pharma
FDA reinstates generic drug policy group let go in April firings
5 weeks ago
Former HHS lawyer on Novavax delay: Mixing politics and approvals 'imperils' public health
5 weeks ago
FDA adds biomarker limits to stomach, esophageal cancer labels for Merck's Keytruda and BMS' Opdivo
5 weeks ago
Pharma
Updated: Merck wins FDA approval for RSV antibody drug, making a hot market more competitive
5 weeks ago
R&D
Pharma
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