FDA+ channel feed

FDA won't re­or­ga­nize med­ical prod­uct cen­ters, Makary says in in­ter­view: 'I re­ject­ed that pro­pos­al'

4 weeks ago

FDA de­lays PDU­FA date for small biotech, rais­ing ques­tions about im­pact of agency cuts

4 weeks ago

Vaxart says it can re­sume next-gen Covid work, will screen par­tic­i­pants for oral vac­cine tri­al

4 weeks ago
Pharma
Coronavirus

No­vavax re­sponds to FDA’s tri­al ask, with Covid vac­cine strain up­dates un­der scruti­ny

4 weeks ago
Pharma
Coronavirus

Eu­ro­pean reg­u­la­tors rec­om­mend new drugs from Ver­tex, Am­gen and Jazz 

4 weeks ago
Pharma

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

4 weeks ago
R&D
Pharma

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

4 weeks ago
Pharma

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

4 weeks ago
Pharma

Large vac­cine mak­ers stand by their in­vest­ments de­spite US head­winds

5 weeks ago
Pharma

Top phar­ma com­pa­nies in­creased lob­by­ing spend in first quar­ter of 2025

5 weeks ago
Pharma
Law

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

5 weeks ago
Pharma
Coronavirus

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

5 weeks ago
Law

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

Last month

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

Last month

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

Last month
Pharma
Law

FDA ap­proves Dupix­ent for hives, re­jects new Eylea dos­ing sched­ule

Last month

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
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