FDA+ channel feed

FDA+ roundup: Fi­nal guid­ance on the fastest on­col­o­gy drug ap­provals; Re­mote in­spec­tions fail to take off

Last year

Up­dat­ed: Eli Lil­ly's tirzepatide breaks in­to obe­si­ty mar­ket with FDA ap­proval

Last year
Pharma

Sen­ate con­firms Mon­i­ca Bertag­nol­li to lead NIH with bi­par­ti­san 62-36 vote

Last year
Pharma

FTC chal­lenges more than 100 drug patents owned by Ab­b­Vie, As­traZeneca, Boehringer and sev­en oth­ers

Last year
Law

'Pull every lev­er': Marks dou­bles down on ur­gency to im­prove gene ther­a­py man­u­fac­tur­ing

Last year
Pharma
Cell/Gene Tx

HHS says Ste­lara may be de­s­e­lect­ed from Medicare ne­go­ti­a­tions, de­pend­ing on biosim­i­lar launch

Last year
Pharma

House Over­sight Com­mit­tee opens probe in­to FDA's han­dling of drug short­ages

Last year
Manufacturing

BIO, PhRMA press FDA for con­crete de­tails on new IT strat­e­gy

Last year
Pharma

FDA hands In­di­a's Nat­co Phar­ma an­oth­er 483, with eight ob­ser­va­tions cit­ed 

Last year
Manufacturing

Phath­om notch­es FDA ap­proval for Vo­quez­na to treat ero­sive GERD

Last year
Pharma

Sen­ate Fi­nance Com­mit­tee seeks to ad­vance bi­par­ti­san PBM re­forms along­side oth­er health bills

Last year
Law

House Re­pub­li­cans threat­en FDA with sub­poe­na over al­leged in­ad­e­quate lab safe­ty over­sight

Last year
Pharma

FDA par­tial­ly halts Nurix Ther­a­peu­tics’ can­cer tri­al as it im­proves man­u­fac­tur­ing process

Last year
Pharma
Manufacturing

Am­gen’s win for a Ste­lara in­ter­change­able biosim­i­lar prompts ques­tions about ‘mean­ing­ful com­pe­ti­tion’ un­der IRA

Last year
Pharma

No­var­tis scores sixth Cosen­tyx ap­proval from FDA, this time to treat hidradeni­tis sup­pu­ra­ti­va

Last year
Pharma

Q&A: PureTech CEO Daphne Zo­har talks biotech in­ter­ests on Capi­tol Hill

Last year
People

Ver­tex doesn’t need to do more test­ing for rogue gene ed­its from sick­le cell ther­a­py tri­al, FDA ad­vi­sors say

Last year
R&D

Up­dat­ed: Eu­ro­pean Com­mis­sion au­tho­rizes No­vavax's up­dat­ed Covid vac­cine

Last year
Pharma
Coronavirus

FDA push­es can­cer drug de­vel­op­ers to in­clude over­all sur­vival da­ta more fre­quent­ly

Last year
Pharma

As Sarep­ta ex­ecs talk up Duchenne con­fir­ma­to­ry tri­al re­sults, in­vestors and an­a­lysts re­main di­vid­ed on how flex­i­ble FDA will be

Last year
R&D

Biden signs sweep­ing ex­ec­u­tive or­der on AI, with changes com­ing for FDA and health­care

Last year
AI

Oph­thalmic drugs face FDA is­sues again, one man­u­fac­tur­er re­spon­si­ble for 26 con­t­a­m­i­nat­ed prod­ucts

Last year
Manufacturing

Sen­ate De­moc­rats urge Biden ad­min­is­tra­tion to re­quire in­sur­ers to cov­er OTC birth con­trol

Last year
Pharma

No­var­tis strikes a $103M deal for blue­bird's PRV — if it wins one

Last year
Pharma
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