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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