FDA+ channel feed

FDA warns Mex­i­can glyc­erin man­u­fac­tur­er for re­fus­ing an in­spec­tion

3 years ago
Manufacturing

Fight over where to house ARPA-H still brews with House bil­l's pas­sage

3 years ago
Law

Con­gress lays out its de­mands for FDA in 2023 — on every­thing from ma­chine learn­ing to im­munother­a­pies

3 years ago

No­var­tis broad­ens BRAF/MEK can­cer com­bo use, win­ning tu­mor-ag­nos­tic ap­proval in pa­tients 6 and up

3 years ago

FDA+ roundup: Spring reg­u­la­to­ry agen­da looks to fin­ish off Cures im­ple­men­ta­tion; GAO digs in­to med­ical coun­ter­mea­sures

3 years ago

Mer­ck out­flanks Pfiz­er's 20-va­lent shot with pneu­mo­coc­cal vac­cine ap­proval for kids

3 years ago
R&D

Biden nom­i­nates first woman to be top, Sen­ate-con­firmed sci­ence ad­vi­sor, re­plac­ing Er­ic Lan­der

3 years ago
People

Rare dis­ease out­fit Ac­er fum­bles at FDA, re­ceiv­ing CRL due to lack of in­spec­tion readi­ness at pack­ag­ing man­u­fac­tur­er

3 years ago

FDA ad­vi­sors most­ly agree that Aca­dia’s Nu­plazid is­n't ef­fec­tive at treat­ing Alzheimer’s-re­lat­ed psy­chosis

3 years ago

Push­ing for top spot in Big Phar­ma, Ab­b­Vie lands a key ap­proval for its block­buster Skyrizi

3 years ago
Pharma

Rhythm gets sec­ond OK for ge­net­ic obe­si­ty drug Im­civree, swings in­to roy­al­ty deal

3 years ago
Deals
Pharma

FDA au­tho­rizes Pfiz­er, Mod­er­na Covid-19 vac­cines for chil­dren as young as 6 months

3 years ago
Pharma
Coronavirus

Reg­u­lat­ing new re­gen­er­a­tive ther­a­pies: FDA kicks off the process of rec­og­niz­ing vol­un­tary stan­dards

3 years ago
Cell/Gene Tx

House sub­com­mit­tee ad­vances 10% bud­get in­crease for FDA in 2023

3 years ago

Over­sight from FDA at phar­ma man­u­fac­tur­ing sites dipped dur­ing 2021 pan­dem­ic

3 years ago
Manufacturing

FDA's ad­comm votes unan­i­mous­ly in fa­vor of Mod­er­na and Pfiz­er's Covid-19 vac­cines for the youngest chil­dren

3 years ago
Coronavirus

Mak­e­na's ac­cel­er­at­ed ap­proval with­draw­al hear­ing set for Oc­to­ber as Co­vis wants to do more re­search

3 years ago
Pharma

Sen­ate com­mit­tee ad­vances FDA user fee bill with ac­cel­er­at­ed ap­proval re­forms

3 years ago

Brief­ing docs for Aca­di­a's Alzheimer's-re­lat­ed psy­chosis re­sub­mis­sion re­veal an un­de­cid­ed FDA

3 years ago

FDA warns Span­ish drug and API man­u­fac­tur­er over mul­ti­ple pro­duc­tion line prob­lems

3 years ago
Manufacturing

Lil­ly's Olu­mi­ant gets new FDA ap­proval, nab­bing a land­mark green­light for au­toim­mune hair loss dis­ease

3 years ago
Pharma

Up­dat­ed: Al­ny­lam scores OK for sec­ond-gen hAT­TR ther­a­py as the space heats up

3 years ago
Pharma

Ger­man man­u­fac­tur­er hit with Form 483 for mul­ti­ple pro­duc­tion is­sues

3 years ago
Manufacturing

CBER to in­dus­try: Nor­mal op­er­a­tions will re­sume in 2023

3 years ago
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