FDA+ channel feed

BIO and a string of CEOs is­sue a call for FDA in­de­pen­dence and against sci­ence-by-press-re­lease

5 years ago
Pharma

FDA sends warn­ing let­ter to My­lan over 'i­nad­e­quate' man­u­fac­tur­ing process­es at In­dia plant

5 years ago

Bris­tol My­ers snares an­oth­er ap­proval from the old Cel­gene pipeline, nab­bing an over­looked OK

5 years ago
Pharma

FDA re­leas­es PDU­FA VI pro­gram re­port on com­bi­na­tion prod­ucts

5 years ago

New analy­sis shows in­clisir­an con­sis­ten­cy in LDL-C re­duc­tion as No­var­tis read­ies for FDA de­ci­sion

5 years ago
R&D

FDA drafts rec­om­men­da­tions for study­ing can­cer drugs in pa­tients with CNS metas­tases

5 years ago

Cos­mo spin­out Cas­sio­pea wins FDA ap­proval for new ac­ne drug

5 years ago
R&D

Ex­clu­sive: We asked for bio­phar­ma's opin­ion about the plas­ma EUA. The in­dus­try of­fered a dou­ble-bar­reled re­sponse

5 years ago
Coronavirus

Tri­ci­da 'fore­shad­owed' its CRL — but shares still fall with fear of years-long de­lay

5 years ago
R&D

Trump her­alds a 'his­toric break­through' in the R&D fight against Covid-19 — now comes the in­stant back­lash as the FDA pro­vides a con­tro­ver­sial as­sist

5 years ago
Coronavirus

J&J adds yet an­oth­er mul­ti­ple myelo­ma reg­i­men to the Darza­lex la­bel as Sanofi ri­val jumps in

5 years ago
R&D

No­var­tis gets the green light to start mar­ket­ing its next prospec­tive block­buster. And they're charg­ing a pre­mi­um for con­ve­nience

5 years ago
R&D

In an­oth­er shock­er, FDA re­jects Bio­Marin’s he­mo­phil­ia A gene ther­a­py, de­mand­ing more da­ta on dura­bil­i­ty

5 years ago
R&D

PDU­FA meet­ing airs in­dus­try's take on time­li­ness, qual­i­ty of FDA com­mu­ni­ca­tions

5 years ago

FDA hands Gilead a stun­ning re­jec­tion for block­buster RA can­di­date fil­go­tinib, deal­ing CEO O’Day a ma­jor set­back

5 years ago
R&D

My­lan wins ear­ly FDA OK of a Tec­fidera knock­off, and they're launch­ing with an eye to top­pling Bio­gen's block­buster fran­chise

5 years ago
R&D

As­traZeneca is chang­ing up dos­ing reg­i­mens of its check­point play­er in the face of the pan­dem­ic. The FDA ap­pears ready to make a quick as­sist

5 years ago
R&D

New­ly ar­rived on Nas­daq, Po­sei­da qui­et­ly sig­nals a clin­i­cal hold trig­gered by a pa­tient death in PhI — shares crater

5 years ago
R&D

Ned Sharp­less' 'brain­child' nabs a speedy FDA re­view for small cell lung can­cer drug

5 years ago
R&D

FDA slaps clin­i­cal hold on Ap­plied Ther­a­peu­tics af­ter sav­age fight over short at­tack

5 years ago

FDA ap­proves the third NMOSD drug in 18 months as Roche/Genen­tech beefs up its port­fo­lio of drugs for neu­ro­log­i­cal dis­or­ders

5 years ago
R&D

FDA's ODAC shrugs off ob­jec­tions to Mesoblast's GVHD drug for chil­dren, vot­ing 9-1 in fa­vor and im­prov­ing the odds of an ap­proval

5 years ago

FDA puts up a red light for Pas­sage Bio’s first gene ther­a­py pro­gram, de­lay­ing a pro­gram from James Wilson's group at Penn

5 years ago
R&D

The FDA just ap­proved the third Duchenne MD drug. And reg­u­la­tors still don’t know if any of them work

5 years ago
Pharma
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