FDA+ channel feed

Rul­ing in SCO­TUS mifepri­s­tone case could lead to end­less lit­i­ga­tion, in­dus­try says

Last year
Pharma
Law

Apoc­a­lypse or rip­ple? Ahead of first of­fers on price, new re­search pre­dicts IRA im­pact on R&D will be mod­est

Last year
R&D

FDA Com­mis­sion­er Robert Califf high­lights need for ‘cre­ative ap­proach­es’ for rare dis­ease ther­a­pies

Last year

FDA re­jects mo­tion sick­ness drug from De­fend­er Phar­ma

Last year
Pharma

Sen­a­tor turns up heat on in­haler man­u­fac­tur­ers to re­move im­prop­er­ly list­ed Or­ange Book patents

Last year
Pharma

Ex­clu­sive: Eli Lil­ly sup­plied schiz­o­phre­nia drug to un­cer­ti­fied health­care providers, Form 483 shows

Last year
Pharma

Ex­it in­ter­view: FDA leg­end Janet Wood­cock­'s thoughts on the agency and its con­tro­ver­sies

Last year
People

FDA sched­ules March ODAC for Geron's MDS drug fol­low­ing PhI­II da­ta

Last year
R&D

FDA up­dates draft guid­ance on race and eth­nic­i­ty re­port­ing in clin­i­cal tri­als

Last year

GSK shoots for RSV la­bel ex­pan­sion in younger adults in Eu­rope in race against Pfiz­er’s Abrys­vo

Last year
Pharma

FDA fi­nal­izes CAR-T and gene ther­a­py guid­ance, of­fers sup­port for ac­cel­er­at­ed ap­provals

Last year
Cell/Gene Tx

Two new drugs get pos­i­tive rec­om­men­da­tions from EMA com­mit­tee, while two oth­ers get thumbs-down

Last year
Pharma

Com­pe­ti­tion en­force­ment led to fair­er prices, in­no­v­a­tive prod­ucts — EC re­port

Last year
Pharma

Re­mote man­u­fac­tur­ing as­sess­ments: FDA re­vis­es draft guid­ance to in­clude new­ly ex­pand­ed pow­ers

Last year
Manufacturing

As PBMs face threats in Wash­ing­ton, in­dus­try trade group poured mil­lions more in­to lob­by­ing

Last year
Pharma

‘I think we will have the votes’: Sanders gears up to sub­poe­na CEOs of J&J, Mer­ck to tes­ti­fy on drug prices

Last year
Pharma

Fol­low­ing CAR-T safe­ty la­bel changes, FDA of­fi­cials share new de­tails about sec­ondary can­cer cas­es

Last year
Pharma
Cell/Gene Tx

FDA up­dates Gilead­'s la­bel for CAR-T Tecar­tus with new boxed warn­ing for sec­ondary can­cer

Last year
Pharma
Cell/Gene Tx

Phar­ma com­pa­nies to re­main mum on CM­S' ini­tial of­fers next week for the first year of IRA ne­go­ti­a­tions

Last year
Law

CMC con­cerns lead to FDA re­jec­tion of Ther­at­e­ch­nolo­gies’ con­cen­trat­ed ver­sion of lipody­s­tro­phy drug for HIV pa­tients

Last year
Manufacturing

Up­dat­ed: Gilead’s Tecar­tus dropped from list of CAR-Ts with up­dat­ed boxed warn­ings

Last year
Pharma
Cell/Gene Tx

Bi­par­ti­san group of law­mak­ers seeks to reign in phar­ma patent thick­ets with new bill

Last year
Pharma

Up­dat­ed: FDA’s safe­ty re­view on CAR-Ts cul­mi­nates in new boxed warn­ings of sec­ondary can­cer

Last year
Pharma
Cell/Gene Tx

Au­to­lus eyes No­vem­ber for po­ten­tial US ap­proval of Tecar­tus ri­val

Last year
Pharma
Cell/Gene Tx
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