FDA+ channel feed

FDA says it needs a lit­tle more time to de­cide on Mer­ck­'s P2X3 for chron­ic cough

4 years ago

Two da­ta fal­si­fiers sen­tenced to prison as FDA pledges to crack down on those un­der­min­ing clin­i­cal tri­als

4 years ago

Aprea dis­clos­es sec­ond clin­i­cal hold in a week, this time for lym­phoma study

4 years ago

First gener­ic com­pe­ti­tion ar­rives for Pfiz­er's megablock­buster an­ti-smok­ing drug

4 years ago
Pharma

Mer­ck nabs ap­proval for Keytru­da com­bo in kid­ney can­cer af­ter prov­ing it can ex­tend sur­vival

4 years ago
R&D

FDA re­jects Fi­bro­Gen's ane­mia drug, de­mand­ing an ad­di­tion­al clin­i­cal tri­al

4 years ago
Pharma

Opin­ion: Plen­ty of qual­i­fied peo­ple are ready to run the FDA. Time for Biden to choose one

4 years ago
People

Pri­or­i­ty re­view vouch­er up­dates: Who's won PRVs, who's bought them, and how much they're sell­ing for

4 years ago
R&D

Blue­bird forced to halt tri­als af­ter a can­cer-like case, pulls gene ther­a­pies from Eu­rope fol­low­ing pric­ing back­lash — shares slammed

4 years ago
R&D
Cell/Gene Tx

Let­ter from FDA out­lin­ing de­fi­cien­cies for lead drug caus­es Ax­some stock to crater. Is a CRL on the way?

4 years ago
R&D
Pharma

Sanofi wins ap­proval for Lu­mizyme suc­ces­sor, al­though up­take re­mains a mys­tery

4 years ago
Pharma

FDA shoots down Spec­trum's neu­trope­nia drug, cit­ing man­u­fac­tur­ing is­sues

4 years ago
Manufacturing

Court de­ci­sion push­es FDA to make his­tor­i­cal shift and reg­u­late bor­der­line drug/de­vice prod­ucts as de­vices

4 years ago

FDA or­ders clin­i­cal hold on Aprea's p53 re­ac­ti­va­tor as strug­gling biotech pledges to ad­dress safe­ty con­cerns

4 years ago

No­vavax shares dive on yet an­oth­er stum­ble in the hunt for an EUA, with FDA de­lay as US paus­es fund­ing

4 years ago

ICER of­fers fi­nal ver­dict against Bio­gen's ad­u­canum­ab: No proof it works, clear prospect of harm, wild­ly over­priced

4 years ago

HHS ex­tends Aduhelm in­ves­ti­ga­tion in­to the ac­cel­er­at­ed ap­proval path­way, wad­ing in­to a brew­ing con­tro­ver­sy

4 years ago

Bio­gen, Ei­sai are push­ing for an­oth­er ac­cel­er­at­ed Alzheimer's OK — this time for BAN2401

4 years ago

FDA slaps back small-cap's bid to re­pur­pose 50-year-old chemother­a­py

4 years ago

Arde­lyx chops a third of its staff af­ter stock-crush­ing fail­ure in chron­ic kid­ney dis­ease

4 years ago
People

Opin­ion: Pric­ing in­fo with new drug ap­provals: Time for trans­paren­cy

4 years ago
Opinion

FDA lifts year-plus hold on No­var­tis' Zol­gens­ma, set­ting the stage for new PhI­II

4 years ago
Cell/Gene Tx

Rare dis­ease drug­mak­ers to Con­gress: Don't gut the ac­cel­er­at­ed ap­proval path­way

4 years ago

Af­ter strug­gling with its sole drug for years, Mar­i­nus rides pos­i­tive da­ta to a com­mer­cial­iza­tion deal in Eu­rope

4 years ago
Deals
First page Previous page 102103104105106107108 Next page Last page
A service from the Financial Times