FDA+ channel feed

FDA still not ready to go back to ac­tu­al in-per­son meet­ings with bio­phar­ma spon­sors

3 years ago

FDA warn­ing let­ters de­tail is­sues for man­u­fac­tur­ing sites in the US and In­dia

3 years ago
Pharma
Manufacturing

For months Biden has tout­ed his win over phar­ma in the elec­tion lead-up. Will it help?

3 years ago
Law

FDA warns Ama­zon again for sell­ing un­ap­proved drugs on­line

3 years ago

New JA­MA study digs in­to the rise of stack­ing FDA’s ex­pe­dit­ed pro­grams and des­ig­na­tions for new drugs

3 years ago

FDA clar­i­fies when spon­sors' ex­pand­ed ac­cess poli­cies need to be made pub­lic

3 years ago

Up­dat­ed: Eli Lil­ly blames Biden's IRA for can­cer drug dis­con­tin­u­a­tion as the new phar­ma play­book takes shape

3 years ago
R&D

FDA to kick off CMC readi­ness pi­lot pro­gram next April

3 years ago
Pharma
Manufacturing

Am­i­cus ex­ecs get back up smil­ing af­ter be­ing scuffed again by lat­est set­back

3 years ago

Cit­ing too many da­ta con­founders, FDA ad­comm unan­i­mous­ly votes against Y-mAb­s' drug for rare brain can­cer

3 years ago
Pharma

EMA lim­its use of JAK in­hibitors for at-risk groups in wake of safe­ty con­cerns

3 years ago
Pharma

Pen­ny stock forges ahead with an NDA for Duchenne treat­ment, seek­ing pri­or­i­ty re­view

3 years ago
R&D

Gilead­'s $1.7B hep D drug just ran in­to a road­block at the FDA

3 years ago
Pharma

FDA rais­es ef­fi­ca­cy con­cerns with Y-mAb­s' po­ten­tial ther­a­py for pe­di­atric neu­rob­las­toma ahead of ODAC meet­ing

3 years ago
R&D

Ad­comm of­fers mixed vote, rec­om­mends GSK's kid­ney dis­ease drug in just one pa­tient pop­u­la­tion

3 years ago
Pharma

Au­robindo Phar­ma’s US branch is­sues a re­call of a gener­ic med­i­cine

3 years ago
Pharma
Manufacturing

FDA sets Seres on the pri­or­i­ty re­view path for its mi­cro­bio­me C. dif­fi­cile drug, set­ting up April de­ci­sion

3 years ago
R&D

Up­dat­ed: FDA ex­plains why it won't pull Jaz­z's ac­cel­er­at­ed ap­proval de­spite a failed con­fir­ma­to­ry tri­al

3 years ago

Up­dat­ed: Con­t­a­m­i­na­tion is­sues lead to FDA warn­ing let­ter for South Car­oli­na man­u­fac­tur­ing fa­cil­i­ty

3 years ago
Pharma
Manufacturing

FDA ap­proves J&J's BC­MA-tar­get­ed bis­pe­cif­ic for mul­ti­ple myelo­ma

3 years ago
Pharma

Hal­loween ad­comm post­poned as FDA seeks more Ipsen da­ta on ul­tra rare dis­or­der drug can­di­date

3 years ago

FDA rais­es safe­ty ques­tions with GSK's po­ten­tial CKD drug ahead of ad­comm

3 years ago
Pharma

FDA in­spec­tion at Catal­ent’s Bel­gium fa­cil­i­ty un­cov­ers da­ta, equip­ment and oth­er QC is­sues

3 years ago
Pharma
Manufacturing

Re­gen­eron, Bay­er's Eylea nabs six months of pe­di­atric ex­clu­siv­i­ty as com­pe­ti­tion waits to en­ter the mar­ket

3 years ago
Pharma
First page Previous page 67686970717273 Next page Last page
A service from the Financial Times