FDA+ channel feed

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

FDA re­jects Melin­ta, Ve­na­torx’s UTI an­tibi­ot­ic over CMC is­sues

Last year
Manufacturing

FDA grants pri­or­i­ty re­view for Dupix­ent in COPD, sets June ap­proval de­ci­sion dead­line

Last year
R&D

House Dems seek brief­in­gs with Pfiz­er, San­doz and Te­va on on­go­ing drug short­ages

Last year
Pharma

Unit­ed Ther­a­peu­tics sues FDA over han­dling of Liq­uidia’s new drug ap­pli­ca­tion for tre­pros­tinil

Last year
Pharma
Law

House De­moc­rats re­it­er­ate call for FDA to work on clin­i­cal di­ver­si­ty ac­tion plans

Last year
Pharma

SCO­TUS jus­tices hint at un­cer­tain fu­ture of Chevron doc­trine in tan­gen­tial case

Last year
Law

Chi­nese API man­u­fac­tur­er re­ceives FDA warn­ing let­ter af­ter QC em­ploy­ee says test re­sults 'in my mind'

Last year
China
Manufacturing

FDA paus­es RAPT Ther­a­peu­tics’ im­munol­o­gy drug stud­ies af­ter pa­tient ex­pe­ri­ences liv­er fail­ure

Last year
R&D

FDA ap­proves Io­vance's cell ther­a­py for melanoma, the first treat­ment based on tu­mor-in­fil­trat­ing lym­pho­cytes

Last year
Pharma
Cell/Gene Tx

Sen­a­tors call on FDA to ad­dress 'del­uge of mis­lead­ing pro­mo­tion­s' on so­cial me­dia

Last year
Marketing

Organon's Hu­mi­ra biosim­i­lar gets ex­clu­sive spot on VA for­mu­la­ry

Last year
Pharma
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