FDA+ channel feed

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

FDA gives Ax­some speedy re­view for de­pres­sion drug, while oth­er in­di­ca­tions wait in the wings

5 years ago

J&J vac­ci­na­tions re­sume as FDA, CDC con­fi­dent in ben­e­fit-risk pro­file

5 years ago
Coronavirus

ADC Ther­a­peu­tics nabs its first ap­proval as FDA of­fers a quick OK for its DL­B­CL can­cer treat­ment

5 years ago

Roche, Bris­tol My­ers, and Mer­ck prep de­fense for 6 ‘dan­gling’ PD-(L)1 ac­cel­er­at­ed ap­provals, even though they failed con­fir­ma­to­ry tri­als

5 years ago

Shorla Phar­ma scores an ex­pe­dit­ed re­view for its mys­tery can­di­date to treat T-cell ma­lig­nan­cies

5 years ago

How the SCO­TUS de­ci­sion to gut the FTC could help bio­phar­ma com­pa­nies

5 years ago
Pharma
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