endpoints.news is our new home on June 1. endpts.com will still work, but the front door is now https://endpoints.news

FDA+ channel feed

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

GSK and oth­ers delist Or­ange Book patents af­ter FTC tar­gets pro­tec­tions on in­halers and ep­i­neph­rine in­jec­tors

Last year

EMA pre­pares for changes to non-in­fe­ri­or­i­ty, equiv­a­lence study guid­ance

Last year
Pharma

Bio­phar­ma man­u­fac­tur­ers call for clar­i­ty on FDA's ad­vanced des­ig­na­tion guid­ance 

Last year
Manufacturing

FDA ex­pands la­bel for No­var­tis and Roche's block­buster, con­verts EMD Serono's NSCLC drug to full ap­proval

Last year
Pharma

FDA sets June de­ci­sion dead­line for po­ten­tial full ap­proval, la­bel ex­pan­sion of Sarep­ta’s Duchenne gene ther­a­py

Last year
Cell/Gene Tx

FDA goes af­ter web­sites mar­ket­ing 'u­nap­proved' semaglu­tide, tirzepatide

Last year
Pharma
First page Previous page 31323334353637 Next page Last page
A service from the Financial Times