FDA+ channel feed

GSK’s Nu­cala wins COPD ap­proval, stok­ing ri­val­ry with Dupix­ent 

13 hours ago
Pharma

FDA ex­pects 'time­ly avail­abil­i­ty' of Covid shots as ad­vi­sors up­date for­mu­la rec­om­men­da­tion

14 hours ago
Coronavirus

FDA chief to sen­a­tors: 3,000+ staff de­par­tures won't de­lay user fee tar­gets

16 hours ago

The ‘MA­HA re­port’: Four key take­aways on vac­cines, med­i­cine and the phar­ma in­dus­try

18 hours ago
Pharma

FDA ad­comm votes unan­i­mous­ly against Pfiz­er's prostate can­cer drug com­bo

Yesterday
Pharma

FDA asks Covid vac­cine mak­ers to add more my­ocardi­tis da­ta to la­bels

Yesterday
Pharma

FDA an­nounces ef­forts to fa­cil­i­tate drug im­por­ta­tion from Cana­da 

Yesterday
Pharma
Manufacturing

FDA ad­comm nar­row­ly votes against Uro­Gen’s blad­der can­cer drug, calls for RCTs

Yesterday
Pharma

In his first ma­jor pol­i­cy roll­out, Vinay Prasad looks to chal­lenge ex­ist­ing 'dog­ma' on Covid vac­cines

2 days ago
R&D

Up­dat­ed: FDA ad­comm splits votes on Genen­tech and J&J can­cer drugs

2 days ago

RFK Jr. spars with sen­a­tors over re­search cuts, HHS bud­get plan

2 days ago
Pharma

Makary, Prasad spell out FDA ground rules for fu­ture Covid vac­cine ap­provals

2 days ago
Coronavirus

Up­dat­ed: FDA ap­proves No­vavax's Covid vac­cine af­ter six-week de­lay, but for a small­er pop­u­la­tion

4 days ago
Pharma

Sarep­ta seeks to ex­pand Duchenne gene ther­a­py Ele­v­idys use to tod­dlers

6 days ago
R&D

Deputy FDA chief mulls shak­ing up PDU­FA reau­tho­riza­tion struc­ture

6 days ago

FDA pos­es ef­fi­ca­cy, safe­ty ques­tions over four can­cer drugs ahead of two-day ad­comm

6 days ago
Pharma

RFK Jr. adopts new chikun­gun­ya vac­cine guid­ance; oth­er rec­om­men­da­tions re­main un­der re­view

Last week
R&D
Pharma

New CBER chief Prasad is ready­ing 'mas­sive frame­work' around vac­cines, Makary says

Last week
Pharma

FDA warns Mayne Phar­ma over 'mis­lead­ing' pre­sen­ta­tion slides on birth con­trol pill

Last week

Bio­haven stock sinks on three-month de­lay for neu­ro drug's FDA ap­proval de­ci­sion

Last week
Pharma

RFK Jr. de­fends HHS staff cuts, re­or­ga­ni­za­tion plans in House, Sen­ate hear­ings

Last week
Pharma

RFK Jr. says his opin­ions of vac­cines are ‘ir­rel­e­vant.’ For­mer FDA chief Califf dis­agrees

Last week
Pharma

FDA gives Ab­b­Vie ac­cel­er­at­ed ap­proval for an­ti­body-drug con­ju­gate in lung can­cer

Last week
Pharma

GSK awaits Nu­cala de­ci­sion af­ter FDA tar­get date pass­es

2 weeks ago
Pharma
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