FDA+ channel feed

Re­call re­port: Acel­la pulls thy­roid tablets af­ter a raft of side ef­fect re­ports; mis­la­bel­ing caus­es Pfiz­er's Hos­pi­ra to yank 2 lots of anes­thet­ics

5 years ago
Manufacturing

Biden ad­min­is­tra­tion backs a po­lar­iz­ing pro­pos­al to waive IP for all Covid-19 vac­cines

5 years ago
Pharma
Manufacturing

FDA ex­tends re­search agree­ment with MIT-li­censed or­gan-on-chip sys­tems

5 years ago
Pharma

In quest to meet user fee goals, FDA’s per­for­mance con­tin­ues down­ward trend

5 years ago
Pharma

Opin­ion: Waiv­ing Covid-19 vac­cine IP could save lives, but where is the man­u­fac­tur­ing ca­pac­i­ty?

5 years ago
Opinion

Chemo­Cen­tryx plunges as FDA rais­es ques­tions about rare dis­ease drug ahead of ad­comm

5 years ago
Pharma

Sig­ma-Aldrich hit with $9M fine for mis­lead­ing in­fo dur­ing Mer­ck KGaA merg­er

5 years ago
Deals

ICH plots ma­jor over­haul of good clin­i­cal prac­tice guide­line

5 years ago
R&D

As­traZeneca's big CKD promis­es come to fruition as Farx­i­ga wins ap­proval in pa­tients re­gard­less of di­a­betes sta­tus

5 years ago

Bio­gen won’t ex­plain why FDA slapped down their bid for new Tysabri for­mu­la­tion

5 years ago
Pharma

Bris­tol My­er­s' Op­di­vo scores pri­or­i­ty re­view in com­mon blad­der can­cer, mark­ing lat­est win in PD-1 bat­tle with Keytru­da

5 years ago
Pharma

More in­fo on drug re­view time­lines? HHS and FDA pull Trump HHS’ last-minute pledge

5 years ago
Pharma

FDA hits Leo Phar­ma with a CRL for what the biotech says are ques­tions about the 'de­vice com­po­nen­t' of eczema can­di­date

5 years ago

Mer­ck, Roche and Bris­tol My­ers nab 4 of 6 pos­i­tive ODAC votes for ‘dan­gling’ ac­cel­er­at­ed ap­provals

5 years ago
R&D
Pharma

FDA pan­dem­ic de­lays strike again with Is­raeli mi­cro­cap the lat­est to re­ceive a CRL based on in­spec­tion set­backs

5 years ago

ODAC votes to keep Keytru­da and Tecen­triq ac­cel­er­at­ed ap­provals in blad­der can­cer

5 years ago
Pharma

FDA warns Ac­celeron of pos­si­ble fines for not post­ing re­sults from failed tri­al

5 years ago

With Amy Aber­nethy out, Vid De­sai takes over as FDA’s act­ing CIO

5 years ago

Opin­ion: Mean­ing­ful drug pric­ing re­forms are head­ed nowhere fast

5 years ago
Pharma
Opinion

Tech glitch­es over­shad­ow FDA on­col­o­gy ad­comm as a sol­id ma­jor­i­ty of ad­vis­ers vote to keep Roche's Tecen­triq in mTNBC

5 years ago
R&D

Af­ter fac­ing a 16-month so­journ dur­ing Covid to over­come a stun­ning CRL, lit­tle En­zy­vant says it's back on track — ex­pects mar­ket­ing de­ci­sion lat­er this year

5 years ago
Startups

For tai­lored, sin­gle-per­son an­ti­sense oligonu­cleotides, FDA of­fers guid­ance on non­clin­i­cal test­ing

5 years ago
Cell/Gene Tx

Biden signs two bills to clar­i­fy new chem­i­cal en­ti­ties, ed­u­cate on biosim­i­lars

5 years ago
Pharma

UniQure gets an­oth­er shot with he­mo­phil­ia gene ther­a­py af­ter FDA lifts clin­i­cal hold; Ne­oleuk­in's IL-2 hope­ful al­so cleared

5 years ago
Cell/Gene Tx
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