FDA+ channel feed

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

Last year
Pharma

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

Last year
Pharma

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

Last year
Pharma

CBER's Pe­ter Marks shares pan­dem­ic lessons as FDA con­tin­ues 'go­ing through the back­log'

Last year
People
Pharma

FDA to im­port ver­sions of com­mon can­cer drug to al­le­vi­ate short­age

Last year
Pharma
Manufacturing

Up­dat­ed: FDA pulls paid Ei­sai con­sul­tant from tem­po­rary role on ad­comm re­view­ing Ei­sai's new Alzheimer's drug

Last year

As­traZeneca moves ear­ly for full ap­proval with an­ti­co­ag­u­lant re­ver­sal drug An­dexxa af­ter pos­i­tive PhIV da­ta

Last year
R&D

FDA lifts hold on Mol­e­c­u­lar Tem­plates’ mul­ti­ple myelo­ma tri­al af­ter less than two months

Last year
R&D

FDA ap­proves Pfiz­er’s RSV shot for old­er adults, tee­ing up a com­pet­i­tive $17B vac­cine mar­ket

Last year
Pharma

FDA's can­cer chief weighs in on com­mon chemo short­ages — re­port

Last year
Pharma
Manufacturing

FDA warns about com­pound­ed semaglu­tide-based drugs

Last year
Pharma
Manufacturing

FDA in­spec­tion of Chi­na-based site mak­ing Co­herus' po­ten­tial new can­cer drug ends with three ob­ser­va­tions

Last year
China

Clin­i­cal hold for Pep­Gen's my­oton­ic dy­s­tro­phy pro­gram halts march to the clin­ic

Last year

FDA in­spec­tion of UCB fa­cil­i­ty in Bel­gium finds sev­er­al qual­i­ty is­sues

Last year
Manufacturing

A decade in the mak­ing: FDA pro­pos­es new, easy-to-read pa­tient med­ica­tion guide

Last year

Eli Lil­ly set­tles in­sulin pric­ing law­suit for $13.5M, month­ly out-of-pock­et com­mit­ment

Last year
Pharma

EU com­mit­tee like­ly to rec­om­mend against ap­prov­ing Amy­lyx ALS drug, com­pa­ny says

Last year
R&D
Pharma

FDA ap­proves Lex­i­con’s heart-fail­ure drug af­ter de­feat in di­a­betes

Last year
Pharma

Take­da wins pri­or­i­ty re­view for $400M col­orec­tal can­cer drug, li­censed from Hutchmed in Jan­u­ary

Last year
R&D

In 2023, FDA ap­proves far few­er first gener­ic drugs than in re­cent years

Last year

More than a year af­ter its emer­gency au­tho­riza­tion, FDA ful­ly ap­proves Pfiz­er's Covid pill Paxlovid for adults

Last year
Coronavirus

Gen­er­al­ly ac­cept­ed sci­en­tif­ic knowl­edge: FDA ex­plains how it ap­plies to non­clin­i­cal da­ta in drug apps

Last year
First page Previous page 51525354555657 Next page Last page
A service from the Financial Times