FDA+ channel feed

FDA hands CRL to Mer­ck­'s chron­ic cough drug over ef­fi­ca­cy ques­tions

Last year
R&D

FDA to set up new Of­fice of the Chief Med­ical Of­fi­cer as part of agency reshuf­fling

Last year
Pharma

Genen­tech's food al­ler­gy med­ica­tion gets pri­or­i­ty re­view nod from the FDA

Last year
Pharma

FDA en­cour­ages col­lab­o­ra­tion be­tween mon­o­clon­al an­ti­body spon­sors to keep pace with emerg­ing Covid vari­ants

Last year
R&D
Pharma

FDA ap­proves Chiesi’s gel for rare skin dis­ease af­ter ini­tial 2022 re­jec­tion for Am­ryt

Last year
Pharma

Mer­ck clinch­es pri­or­i­ty re­view for pneu­mo­coc­cal vac­cine, rais­ing stakes for Pfiz­er

Last year
Pharma

FDA broad­ens au­tho­riza­tion for Ak­il­i's video game for AD­HD

Last year
Pharma

Ar­cutis scores FDA ap­proval for new foam treat­ment for com­mon skin con­di­tion

Last year
Pharma

FDA fi­nal­izes opi­oid safe­ty la­bel­ing changes

Last year
Pharma

FDA re­jects Check­point Ther­a­peu­tic­s' PD-L1 drug cosi­be­limab over man­u­fac­tur­ing is­sues

Last year
Manufacturing

Mer­ck­'s Welireg wins la­bel ex­pan­sion in kid­ney can­cer de­spite miss­ing sur­vival da­ta

Last year
Pharma

FDA con­verts ac­cel­er­at­ed to full ap­proval for Pad­cev-Keytru­da com­bo in blad­der can­cer

Last year
Pharma

Eu­rope lines up first CRISPR ther­a­py ap­proval

Last year
Pharma

Patent thick­et strat­e­gy with ter­mi­nal dis­claimers helps block bi­o­log­ic com­pe­ti­tion, JA­MA let­ter shows

Last year
Law

Re­pub­li­cans pres­sure FDA on for­eign in­spec­tions, threat­en sub­poe­na 

Last year
Pharma
Manufacturing

FDA ap­proves high-risk neu­rob­las­toma treat­ment for kids and adults

Last year
Pharma

Sanofi and As­traZeneca to make 230,000 ad­di­tion­al RSV im­mu­niza­tions avail­able, White House says

Last year
Pharma
Manufacturing

White House keeps fo­cus on low­er­ing drug prices, turns Re­gen­eron's con­tract lan­guage in­to new stan­dard

Last year
Pharma
Law

FDA puts three CARs­gen CAR-T ther­a­pies on clin­i­cal hold, in­clud­ing Mod­er­na-part­nered pro­gram

Last year
Cell/Gene Tx
Manufacturing

Sen­ate health com­mit­tee ad­vances changes to how FDA would ap­prove new opi­oids

Last year
Law

House pass­es sweep­ing health­care price trans­paren­cy re­forms, rein­ing in PBM prac­tices

Last year
Pharma

FDA es­tab­lish­es new ad­vi­so­ry com­mit­tee for ge­net­ic meta­bol­ic dis­ease treat­ments

Last year
Pharma

FDA rolls out new draft guid­ance on ad­vanced man­u­fac­tur­ing tech

Last year
Pharma
Manufacturing

FDA sets late 2024 de­ci­sion dead­line for Pfiz­er’s 'pan-he­mo­phil­i­a' drug: #ASH23

Last year
R&D
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