FDA+ channel feed

Aldeyra suf­fers re­jec­tion in rare eye can­cer due to 'lack of sub­stan­tial ev­i­dence' but seeks use un­der Ex­pand­ed Ac­cess

Last year
Pharma

Lupin wins first FDA ap­proval for gener­ic ver­sion of Boehringer In­gel­heim block­buster Spiri­va

Last year
Pharma

FDA+ roundup: Num­ber of drug sur­veil­lance in­spec­tions tripled from 2021 to 2022

Last year

'On track to be­come a block­buster': FDA ap­proves in­jectable form of ar­genx's au­toim­mune drug

Last year
Pharma

Eli Lil­ly, Boehringer In­gel­heim get ap­proval to ex­pand Jar­diance, Syn­jardy la­bels to kids with type 2 di­a­betes

Last year
Pharma

Up­dat­ed: FDA ap­proves an­ti-in­flam­ma­to­ry drug Lodoco to treat car­dio­vas­cu­lar dis­ease

Last year

F2G gets re­ject­ed by the FDA, which wants more da­ta be­fore it will ap­prove an­ti­fun­gal drug, com­pa­ny says

Last year
R&D

House Re­pub­li­cans use FDA ap­pro­pri­a­tions bill to over­ride REMS changes on abor­tion pill

Last year
Law

Drug­mak­ers seek clar­i­ty from FDA on man­u­fac­tur­ing in­ter­rup­tion no­ti­fi­ca­tions

Last year
Manufacturing

VRB­PAC unan­i­mous­ly rec­om­mends mono­va­lent, XBB lin­eage for next fal­l's Covid-19 vac­cine cam­paign

Last year
Coronavirus

San­doz un­veils glob­al ac­tion plan to im­prove ac­cess to biosim­i­lars

Last year
Pharma

Mer­sana slapped with par­tial FDA hold af­ter five pa­tient deaths in ovar­i­an can­cer stud­ies

Last year
R&D

To restart com­mon can­cer drug pro­duc­tion short­ly, FDA work­ing close­ly with Ac­cord

Last year
Pharma
Manufacturing

Vi­a­tris pe­ti­tions FDA over would-be EpiPen com­peti­tor, claim­ing more da­ta nec­es­sary

Last year

$1 Dara­prim? Im­prim­is­Rx fa­cil­i­ty in New Jer­sey hit with FDA warn­ing let­ter

Last year
Pharma
Manufacturing

FDA lays out what to ex­pect at ad­com­m's se­lec­tion of strains for Covid-19 vac­cine cam­paign this fall

Last year
Coronavirus

FDA ad­comm votes unan­i­mous­ly in fa­vor of full ap­proval for Ei­sai's new Alzheimer's drug

Last year
Pharma

FDA sets De­cem­ber ap­proval de­ci­sion for first CRISPR ther­a­py, with 94% of pa­tients free of sick­le cell crises

Last year
R&D
Cell/Gene Tx

FDA ad­comm votes unan­i­mous­ly in fa­vor of As­traZeneca's pre­ven­tive mAb for RSV in in­fants

Last year

FDA shakes up top lead­er­ship around gener­ic drugs

Last year
People

FDA ac­cepts an­oth­er sBLA for Mer­ck­'s Keytru­da, fol­low­ing Imfinzi in bil­iary tract can­cer

Last year

FDA com­mis­sion­er says drug prices are too high, calls for bet­ter ev­i­dence gen­er­a­tion

2 years ago
Pharma

Up­dat­ed: FDA sig­nals like­ly full ap­proval for Ei­sai's new Alzheimer's drug ahead of Fri­day's ad­comm

2 years ago
Pharma

As­traZeneca, Sanofi's RSV an­ti­body set for FDA ad­comm on Thurs­day

3 years ago
Pharma
First page Previous page 52535455565758 Next page Last page
A service from the Financial Times