FDA+ channel feed

FDA ap­proves Dupix­ent for hives, re­jects new Eylea dos­ing sched­ule

4 weeks ago

GSK kicks off Blenrep re­launch plans with clear­ance from UK reg­u­la­tors

Last month
Pharma

CMS would ab­sorb 340B drug dis­count pro­gram un­der leaked HHS re­or­ga­ni­za­tion pro­pos­al

Last month
Pharma

Phar­ma's wins and loss­es in Trump's sprawl­ing ex­ec­u­tive or­der on drug prices

Last month
Pharma
Law

At ACIP hear­ing, CDC says it's 'scrap­ing' to re­spond to measles out­break; FDA com­ments on No­vavax halt

Last month
Pharma

Click gets FDA au­tho­riza­tion for pre­ven­tive mi­graine dig­i­tal ther­a­peu­tic

Last month
Health Tech

Leqem­bi wins EU au­tho­riza­tion for some Alzheimer's pa­tients, giv­ing Bio­gen, Ei­sai a boost over Lil­ly

Last month
Pharma

CDC vac­cine ad­vi­sors are set to meet this week af­ter two-month de­lay and scruti­ny from Kennedy

Last month
R&D
Pharma

Ab­b­Vie and San­doz agree to drop court spat over Rin­voq patents

Last month
Pharma

FDA's union read­ies ne­go­ti­a­tions with HHS over some fired staff

Last month

San­doz sues Am­gen over nine-year launch de­lay for En­brel biosim­i­lar

Last month
Pharma
Law

Iron­wood to look for al­ter­na­tive paths af­ter FDA asks for an­oth­er Phase 3

Last month
Pharma

Makary wants to re­place an­i­mal test­ing with organoids. It may take a while

Last month
R&D

Bris­tol My­er­s' im­munother­a­py com­bo nets ap­provals in col­orec­tal and liv­er can­cer

Last month
R&D

CD­MOs an­tic­i­pate in­spec­tion bot­tle­necks af­ter mass FDA fir­ings

Last month
Manufacturing

FDA qui­et­ly be­gins re­vers­ing re­turn-to-of­fice man­date for some work­ers

Last month

Biotech CEOs to Cas­sidy: We're al­ready see­ing the ef­fects of FDA's staff cuts

Last month
Pharma

Fir­ings of HH­S' pro­ba­tion­ary work­ers can pro­ceed, ap­peals court says

Last month
Law

Drug pric­ing watch­dog ICER of­fers ways to in­crease obe­si­ty drug ac­cess

Last month
Pharma

House pan­el mulls ways to boost strug­gling US biosim­i­lar mar­ket

Last month
Law

Could Kennedy's FDA cuts trig­ger an ob­scure claw­back pro­vi­sion for in­dus­try user fees?

Last month
Law

Rare dis­ease hub at CDER and CBER faces new re­al­i­ty with staff crunch

Last month
Pharma

‘This is self-in­flict­ed’: Leerink’s David Risinger on the mar­ket shock and hits to bio­phar­ma

Last month
People

RFK Jr. won’t tes­ti­fy be­fore key Sen­ate com­mit­tee this week on HHS over­haul

Last month
Pharma
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