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FDA chief Makary talks ex­pe­dit­ing drug ap­provals, RIFs and the abor­tion pill

Yesterday
R&D
Pharma

On­ly two-thirds of FDA-ap­proved biosim­i­lars have launched, re­port finds

2 days ago
Pharma

Cas­sidy urges con­gres­sion­al re­forms to 340B drug dis­count pro­gram af­ter in­ves­ti­ga­tion

2 days ago
Pharma

Large vac­cine mak­ers stand by their in­vest­ments de­spite US head­winds

3 days ago
Pharma

Top phar­ma com­pa­nies in­creased lob­by­ing spend in first quar­ter of 2025

3 days ago
Pharma
Law

FDA asks No­vavax for post-mar­ket­ing da­ta of its Covid vac­cine, de­lay­ing ap­proval

3 days ago
Pharma
Coronavirus

Re­cent FDA staff cuts to de­lay drug hear­ing de­ci­sion by months, agency tells Van­da

4 days ago
Law

FDA plans to ban phar­ma em­ploy­ees from serv­ing on ad­comms. The im­pact will be lim­it­ed

5 days ago

Makary, in one of first com­ments on FDA pol­i­cy, floats new path­way for rare dis­ease drugs

5 days ago

Alvo­gen unit ap­peals court loss shield­ing Bausch Health's IBS drug from gener­ics

5 days ago
Pharma
Law

FDA ap­proves Dupix­ent for hives, re­jects new Eylea dos­ing sched­ule

6 days ago

GSK kicks off Blenrep re­launch plans with clear­ance from UK reg­u­la­tors

Last week
Pharma

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

Last week
Pharma

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

Last week
Pharma
Law

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

Last week
Pharma

Click gets FDA au­tho­riza­tion for pre­ven­tive mi­graine dig­i­tal ther­a­peu­tic

Last week
Health Tech

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

Last week
Pharma

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

Last week
R&D
Pharma

Ab­b­Vie and San­doz agree to drop court spat over Rin­voq patents

Last week
Pharma

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

Last week

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

Last week
Pharma
Law

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

Last week
Pharma

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

3 weeks ago
R&D

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

3 weeks ago
R&D
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