FDA+ channel feed

FDA grants full ap­proval to Leqem­bi, open­ing up cov­er­age of Alzheimer’s drug by Medicare

Last year
Pharma

GAO says FDA's al­lowance of phar­ma­cies to dis­pense abor­tion pill was not sub­ject to con­gres­sion­al re­view

Last year
Pharma

Genen­tech yanks Gavre­to's rare thy­roid can­cer in­di­ca­tion, months be­fore hand­ing it back to Blue­print

Last year
Pharma

FDA lifts par­tial hold on Curis' PhI/II leukemia study as biotech rais­es $15M 

Last year
Financing

Bernie Sanders wants to add price caps to ther­a­pies de­vel­oped with BAR­DA, CDC funds

Last year
Law

Mod­er­na files RSV vac­cine for old­er adults in US and Eu­rope

Last year

FDA re­jects Am­neal's ex­tend­ed-re­lease Parkin­son's treat­ment, seek­ing more safe­ty da­ta

Last year

FDA says Ip­ca Labs failed to ad­dress qual­i­ty is­sues with bad API batch­es

Last year
Manufacturing

FDA and EMA chief med­ical of­fi­cers don’t ex­pect Chat­G­PT to help with drug re­views any­time soon

Last year

Madri­gal seeks ac­cel­er­at­ed ap­proval for ex­per­i­men­tal NASH treat­ment a week af­ter In­ter­cept re­jec­tion

Last year
R&D

Alvotech re­ceives an­oth­er CRL from the FDA for Hu­mi­ra biosim­i­lar can­di­date

Last year
Pharma
Manufacturing

Up­dat­ed: Bio­Marin’s he­mo­phil­ia A gene ther­a­py Roc­ta­vian wins FDA ap­proval af­ter de­lay and re­jec­tion, priced at $2.9M

Last year
Pharma

In a first, FDA signs off on Cell­Tran­s' type 1 di­a­betes cell ther­a­py days af­ter in­dus­try's eyes fix­at­ed on Ver­tex da­ta

Last year
R&D
Cell/Gene Tx

Q&A with Tran­sCel­er­ate’s new CEO Jan­ice Chang: Bring­ing the tri­al in­fra­struc­ture to pa­tients

Last year
R&D

Eton hand­ed sec­ond CRL for methanol poi­son­ing treat­ment

Last year
R&D

FDA plots chal­lenges in im­ple­ment­ing new laws tar­get­ing phar­ma sup­ply chain

Last year
Manufacturing

Af­ter CRL in 2022, Pfiz­er and OP­KO get FDA nod for pe­di­atric growth hor­mone de­fi­cien­cy med

Last year
Pharma

Up­dat­ed: FDA re­jects high­er dose of Re­gen­eron's Eylea af­ter in­spec­tion at con­trac­tor Catal­ent

Last year
Manufacturing

API man­u­fac­tur­er in Chi­na hand­ed warn­ing let­ter af­ter fail­ing to re­spond to the reg­u­la­tor’s re­quests for in­for­ma­tion

Last year
Manufacturing

FDA, EMA ac­cept Pfiz­er's he­mo­phil­ia B gene ther­a­py, set­ting up show­down with CSL Behring

Last year
Pharma

FDA ap­proves first of two UCB myas­the­nia gravis drugs, fol­low­ing Alex­ion and ar­genx’s lead

Last year
R&D

FDA re­view­ers on Ipsen's po­ten­tial ul­tra-rare dis­ease drug: Post-hoc analy­sis may be enough

Last year

Pfiz­er’s alope­cia tablet ap­proved by FDA in adults and teens, win­ning broad­er mar­ket than Lil­ly's Olu­mi­ant

Last year
Pharma

FDA is­sues draft guid­ance for clin­i­cal re­search in­to psy­che­delics

Last year
Discovery
Pharma
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