FDA+ channel feed

Bio­Marin gene ther­a­py could be on hold 'for sev­er­al quar­ter­s' af­ter FDA man­dates new pre­clin­i­cal tests

4 years ago
R&D
Cell/Gene Tx

Af­ter sell­ing off Tib­so­vo and en­tire can­cer pipeline, Agios nets first ap­proval for new 'an­chor pro­duc­t'

4 years ago

FDA says vol­ume man­u­fac­tur­ing dead­line is not a re­quire­ment af­ter drug­mak­ers lash out

4 years ago
Manufacturing

Ed­i­to­r­i­al: With Califf con­firmed, FDA needs to re­turn to pri­or­i­ties lost to the pan­dem­ic and im­prove its mes­sag­ing

4 years ago

Af­ter an about-face on a PhI­II tri­al, FDA sets up an ad­comm to re­view con­tro­ver­sial ALS drug next month

4 years ago
Pharma

Mi­rati gets a stan­dard re­view for its 'break­through' KRAS drug. And that is caus­ing some hand wring­ing

4 years ago
Bioregnum

In a nail-biter, Rob Califf gets a sec­ond shot at FDA com­mis­sion­er with Sen­ate con­fir­ma­tion

4 years ago
People

FDA hits Leg­end Biotech with clin­i­cal hold on CAR-T just days ahead of BC­MA de­ci­sion

4 years ago

FDA keeps clin­i­cal hold in place on Lari­mar's lead drug with job cuts like­ly on the hori­zon

4 years ago

In a cliffhang­er, Rob Califf clears first hur­dle on path to Sen­ate con­fir­ma­tion as next FDA com­mis­sion­er

4 years ago

De­nali of­fers more clues on clin­i­cal hold, turn­ing over FDA wor­ries on pre­clin­i­cal tox for Alzheimer's drug

4 years ago

Eli Lil­ly and Roche ask CMS not to be lumped in with Aduhelm’s re­stric­tive judg­ment

4 years ago

As Omi­cron rages, FDA clears Eli Lil­ly/Ab­Celler­a's new an­ti­body days af­ter $720M sup­ply deal

4 years ago
Coronavirus

FDA re­jects cit­i­zen pe­ti­tion claim­ing Cas­sa­va ma­nip­u­lat­ed da­ta, but the biotech's woes are not over

4 years ago

FDA ad­vi­sors rec­om­mend against ap­prov­ing Eli Lil­ly’s PD-1, cast­ing shad­ow over fu­ture of Chi­na-made can­cer drugs

4 years ago

Sanofi and Re­gen­eron eye younger pa­tients for Dupix­ent amid ris­ing tide of ri­vals in atopic der­mati­tis

4 years ago
Pharma

Rob Califf pledges 'high pri­or­i­ty' ac­cel­er­at­ed ap­proval re­forms as Sen­ate Fi­nance chair backs his nom­i­na­tion at FDA

4 years ago

FDA+ roundup: Biden's sci­en­tif­ic lead­er­ship in ma­jor flux; Cures 2.0 and ARPA-H to be pack­aged to­geth­er

4 years ago

Ed­i­to­r­i­al: Did Rick Paz­dur's big 'no' on Lil­ly's Chi­na-born PD-1 al­so spell the end for price dis­rup­tion?

4 years ago

Pre­ma­ture birth drug saga drags on as Co­vis ques­tions fair­ness of FDA hear­ing

4 years ago

'Reg­u­la­to­ry flex­i­bil­i­ty is not war­rant­ed': FDA balks at al­low­ing Chi­na-on­ly da­ta for Eli Lil­ly's an­ti-PD-1 an­ti­body

4 years ago
China

FDA ‘re-eval­u­at­ing’ ap­provals for TG Ther­a­peu­tics’ can­cer drug af­ter find­ing pos­si­ble in­creased risk of death

4 years ago

AD­Cs in the pipeline: FDA spells out clin­i­cal phar­ma­col­o­gy musts for spon­sors

4 years ago
R&D

Break­ing with past com­ments, FDA's Richard Paz­dur telegraphs rough road ahead for Lil­ly's Chi­na-de­vel­oped can­cer drug

4 years ago
Pharma
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