Pharma channel feed

FDA asks Covid vac­cine mak­ers to add more my­ocardi­tis da­ta to la­bels

4 weeks ago
FDA+

FDA an­nounces ef­forts to fa­cil­i­tate drug im­por­ta­tion from Cana­da 

4 weeks ago
FDA+
Manufacturing

Te­va, No­var­tis get fresh warn­ings from FTC over Or­ange Book patent list­ings

4 weeks ago
Law

FDA ad­comm nar­row­ly votes against Uro­Gen’s blad­der can­cer drug, calls for RCTs

4 weeks ago
FDA+

RFK Jr. spars with sen­a­tors over re­search cuts, HHS bud­get plan

4 weeks ago
FDA+

Up­dat­ed: Trump ad­min­is­tra­tion re­veals 'most fa­vored na­tion' drug price coun­try tar­gets

4 weeks ago
Law

Pfiz­er joins PD-1xVEGF race with $1.25B up­front to Chi­nese biotech 3SBio

4 weeks ago
Deals
China

Ste­lara biosim­i­lars look to gain trac­tion, helped by re­cent lessons from Hu­mi­ra

4 weeks ago

In­tel­li­a's CRISPR ther­a­py like­ly caus­es 'per­ma­nen­t' gene knock­down in AT­TR amy­loi­do­sis

4 weeks ago
R&D
Cell/Gene Tx

Re­gen­eron plans to buy 23andMe for $256M

4 weeks ago
Deals

Up­dat­ed: FDA ap­proves No­vavax's Covid vac­cine af­ter six-week de­lay, but for a small­er pop­u­la­tion

4 weeks ago
FDA+

HHS can re­quire ap­proval for drug­mak­ers to ap­ply 340B re­bate mod­els, court rules

5 weeks ago
Law

FDA pos­es ef­fi­ca­cy, safe­ty ques­tions over four can­cer drugs ahead of two-day ad­comm

5 weeks ago
FDA+

Amarin calls Hik­ma's drug la­bel ar­gu­ments 'idio­syn­crat­ic,' urges high court to de­cline case

5 weeks ago
Law

Mark Cuban com­pounder joins Trump's new man­u­fac­tur­ing ini­tia­tive

5 weeks ago
Manufacturing

Bio­Marin makes Phase 3 buy, pay­ing $270M for rare dis­ease out­fit In­ozyme

5 weeks ago
Deals

Up­dat­ed: No­vo Nordisk CEO to step down amid stock de­cline, time­line for suc­ces­sor un­known

5 weeks ago
People

RFK Jr. adopts new chikun­gun­ya vac­cine guid­ance; oth­er rec­om­men­da­tions re­main un­der re­view

5 weeks ago
R&D
FDA+

'Go ahead and do it': Top RFK Jr. deputy dares drug­mak­ers that might pull man­u­fac­tur­ing over new price pres­sure

5 weeks ago
Manufacturing

Re­gen­eron scores $400M+ ju­ry win in Am­gen cho­les­terol drug spat

5 weeks ago
Law

Ei­sai says Leqem­bi is head­ed for 'de­mand ex­pan­sion phase' in US

5 weeks ago

New CBER chief Prasad is ready­ing 'mas­sive frame­work' around vac­cines, Makary says

5 weeks ago
FDA+

Bris­tol My­ers CEO says Amer­i­ca’s bio­phar­ma pole po­si­tion is not guar­an­teed

Last month
People

Ex­clu­sive: Drug com­pounder Em­pow­er was built on risky short­cuts, ex-em­ploy­ees and in­spec­tions al­lege

Last month
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