FDA+ channel feed

FDA hands warn­ing let­ters to US, In­di­an man­u­fac­tur­ers over glyc­erin con­t­a­m­i­na­tion

3 years ago
Manufacturing

Four years lat­er, FDA fi­nal­izes guid­ance on risk-based mon­i­tor­ing of clin­i­cal tri­als

3 years ago
R&D

In­dus­try lead­ers warn that abor­tion pill rul­ing puts FDA in 'to­tal­ly un­chart­ed ter­ri­to­ry'

3 years ago

FDA puts a hold on Mol­e­c­u­lar Tem­plates' PhI tri­al for can­cer drug

3 years ago

Texas court rul­ing on abor­tion pill opens FDA and its ap­proval de­ci­sions to wider po­lit­i­cal at­tacks

3 years ago

Sam­sung and San­doz ques­tion FDA's 're­search roadmap' for biosim­i­lars de­vel­op­ment

3 years ago
Pharma

FDA fi­nal­ly de­cides to pull preterm birth drug Mak­e­na — ef­fec­tive im­me­di­ate­ly

3 years ago

Uptick in FDA ad­comms com­ing in 2023 as CDER hir­ing picks up, Cavaz­zoni says

3 years ago

FDA is­sues draft guid­ance aimed at curb­ing man­u­fac­tur­ing short­ages

3 years ago
Manufacturing

In­flaRx plans to launch Covid an­ti­body with five-fig­ure price tag

3 years ago
Pharma

FDA clos­es out se­ries of pa­tient-fo­cused drug de­vel­op­ment guid­ance

3 years ago

In­flaRx wins FDA emer­gency use au­tho­riza­tion for Covid an­ti­body

3 years ago
Pharma
Coronavirus

FDA re­quires opi­oid man­u­fac­tur­ers to pro­vide mail-back dis­pos­al op­tion

3 years ago
Pharma
Manufacturing

Seagen, Mer­ck­'s Pad­cev-Keytru­da com­bo snags FDA ac­cel­er­at­ed ap­proval for blad­der can­cer

3 years ago
Pharma

Two pa­tient deaths lead to FDA par­tial hold for Gos­samer tri­al of lym­phoma drug

3 years ago
R&D

More than half of ac­cel­er­at­ed ap­proval con­fir­ma­to­ry tri­als are late, re­searchers write in JA­MA

3 years ago
Pharma

Phar­ma fees to Eu­ro­pean reg­u­la­tor spike thanks to 10% in­fla­tion rate

3 years ago

FDA re­veals clean­ing and test­ing is­sues at Glob­al Phar­ma In­di­an man­u­fac­tur­ing site

3 years ago
Pharma
Manufacturing

FDA cites ‘de­fi­cien­cies’ in As­cendis’ ap­pli­ca­tion for parathy­roid drug, jeop­ar­diz­ing po­ten­tial ap­proval

3 years ago

CHMP gives thumbs-up for We­govy use in ado­les­cents, along with nine new drug rec­om­men­da­tions

3 years ago
R&D

Lu­pus drug de­vel­op­ment mar­ket heat­ing up, while FDA links with ad­vo­ca­cy group to fur­ther ac­cel­er­ate re­search

3 years ago
Pharma
Marketing

Af­ter safe­ty re­view, EMA mir­rors FDA with up­dat­ed rec­om­men­da­tions for JAK in­hibitors

3 years ago

FDA lifts par­tial clin­i­cal hold on Vig­il Neu­ro­science's TREM2 an­ti­body, re­mov­ing dos­ing cap

3 years ago

Ot­su­ka, Lund­beck eye Alzheimer's in­di­ca­tion in FDA ad­comm for Rex­ul­ti la­bel ex­pan­sion

3 years ago
Pharma
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