FDA+ channel feed

Eu­ro­pean Com­mis­sion spells out new pro­pos­als for health tech­nol­o­gy as­sess­ments

Last year
Pharma

San­doz wins FDA ap­proval for first two biosim­i­lars for Am­gen's block­buster bone drug

Last year
Pharma

FDA de­nies hear­ing to Van­da on jet lag in­di­ca­tion for sleep dis­or­der drug

Last year
Pharma

Hugel smooths out wrin­kles with FDA, wins ap­proval for Botox com­peti­tor

Last year
Pharma

J&J's Janssen nabs new in­di­ca­tion, full ap­proval for can­cer drug Ry­bre­vant

Last year
R&D

FDA di­rects spon­sors to keep in­formed con­sent in­fo con­cise, tai­lored to par­tic­i­pants

Last year

GAO di­rects ARPA-H to fi­nal­ize plan for han­dling du­pli­cate re­search

Last year
R&D
Pharma

House com­mit­tee de­bates IRA changes that would im­pact or­phan drugs and oth­er ar­eas

Last year
Pharma

Biden ad­min­is­tra­tion in­vests $48M in AI/ML plat­form to iden­ti­fy rare dis­ease drugs

Last year
AI
Pharma

Mod­er­na spells out rare dis­ease am­bi­tions: 'We have a bunch of INDs planned'

Last year
Pharma

Califf lays out drug short­age land­scape, talks post-mar­ket da­ta col­lec­tion for ac­cel­er­at­ed ap­provals

Last year
Pharma
Manufacturing

On­ly a small frac­tion of rare pe­di­atric des­ig­na­tions have led to vouch­ers, new FDA analy­sis shows

Last year

Ac­cel­er­at­ed ap­proval will be 'the nor­m' for gene ther­a­pies, FDA's Pe­ter Marks says

Last year
Cell/Gene Tx

Ther­at­e­ch­nolo­gies hit with FDA refuse to file let­ter for in­tra­mus­cu­lar ver­sion of HIV drug

Last year
Pharma

Min­er­va's shares sink on re­jec­tion of schiz­o­phre­nia drug

Last year
Pharma

DOJ sub­poe­nas Bio­Marin over spon­sored test­ing pro­gram for rare dis­ease drugs

Last year
Pharma

In­ter­nal doc­u­ments shed new light on Sarep­ta FDA de­ci­sion, which top agency of­fi­cial says was ‘ex­cep­tion­al’

Last year
Cell/Gene Tx

Ad­vi­so­ry com­mit­tee votes aren't go­ing away with in­com­ing re­forms, FDA of­fi­cials say

Last year

FDA of­fi­cials, drug de­vel­op­ers dis­cuss how to stream­line safe­ty mon­i­tor­ing for bi­o­log­ics

Last year
Pharma

New York AG calls for 'more strin­gen­t' Sin­gu­lair safe­ty warn­ings

Last year
Pharma

Te­va and Alvotech's in­ter­change­able Hu­mi­ra biosim­i­lar joins the par­ty

Last year
Pharma

Eu­ro­pean reg­u­la­tor rec­om­mends ap­proval of Carvyk­ti in ear­li­er lines of mul­ti­ple myelo­ma

Last year
R&D

FDA de­clines to is­sue fines for non­com­pli­ant tri­al re­port­ing

Last year
Pharma

FDA for­mal­ly pulls On­copep­tides' can­cer drug af­ter pro­longed back-and-forth

Last year
First page Previous page 30313233343536 Next page Last page
A service from the Financial Times