FDA+ channel feed

Af­ter 18 years in de­vel­op­ment, As­traZeneca’s CT­LA-4 an­ti­body gets the red car­pet treat­ment at the FDA

4 years ago

FDA plots mul­ti-day hear­ing to re­view 'dan­gling' ac­cel­er­at­ed ap­proval that drug­mak­er re­fus­es to pull

4 years ago

Do pa­tients and physi­cians weigh drug risks dif­fer­ent­ly? FDA re­searchers plan to find out

4 years ago
Pharma
Marketing

Will a biotech ri­val fi­nal­ly shake up Ab­b­Vie's $2B Botox cos­met­ic fran­chise? Re­vance will find out soon

4 years ago

FDA's ODAC votes unan­i­mous­ly that fu­ture PI3K in­hibitors should in­clude ran­dom­ized da­ta for blood can­cers

4 years ago
Pharma

Biotech, aca­d­e­m­ic lead­ers en­cour­age FDA to con­sid­er T-cell as­sess­ment in Covid-19 vac­cine tri­als

4 years ago
Coronavirus

Drugs con­tain­ing nano­ma­te­ri­als: FDA fi­nal­izes 2017 guid­ance with sev­er­al changes

4 years ago

GAO: FDA work­ers feared re­tal­i­a­tion for com­ing clean on po­lit­i­cal in­ter­fer­ence be­hind sci­en­tif­ic de­ci­sions

4 years ago

Up­dat­ed: How Gilead, Re­gen­eron and Genen­tech used po­lit­i­cal con­nec­tions to hur­ry their Covid-19 drugs

4 years ago

Te­va re­ceives CRL for re­for­mu­lat­ed schiz­o­phre­nia drug de­vel­oped with French biotech

4 years ago
R&D

FDA warns pe­di­atric neu­rol­o­gist for fail­ing to check el­i­gi­bil­i­ty of tri­al par­tic­i­pants

4 years ago
Pharma

FDA re­view­ers plot case for ran­dom­ized da­ta on blood can­cer PI3K in­hibitors ahead of ad­vi­so­ry meet­ing

4 years ago
Pharma

FDA lawyer digs in her heels as Mak­e­na ac­cel­er­at­ed ap­proval with­draw­al saga drags on

4 years ago

Ax­some agrees to post-mar­ket­ing com­mit­ments with FDA, sig­nal­ing po­ten­tial OK for long-de­layed de­pres­sion drug

4 years ago

En­her­tu nabs pri­or­i­ty re­view for NSCLC as As­traZeneca and Dai­ichi Sankyo con­tin­ue chart­ing a block­buster course

4 years ago
R&D

De­vel­op­ing non-opi­oid pain drugs: Com­pa­nies ques­tion if FDA is rais­ing the bar

4 years ago
R&D

When OS is the 'ul­ti­mate safe­ty end­point': FDA lead­ers ques­tion sin­gle-arm tri­als amid scruti­ny of PI3K drugs for blood can­cer

4 years ago

TG Ther­a­peu­tics with­draws U2 ap­pli­ca­tion — and its com­po­nen­t's ap­provals — one week be­fore ad­comm

4 years ago
R&D

DOJ in­ves­ti­gat­ing Bausch Health over plaque pso­ri­a­sis drug mar­ket­ing — re­port

4 years ago
Pharma

FDA tweaks and fi­nal­izes bioavail­abil­i­ty study guid­ance, but most­ly ig­nores Pfiz­er and Mer­ck sug­ges­tions

4 years ago

Mer­ck wins break­through ther­a­py des­ig­na­tion for po­ten­tial pneu­mo­coc­cal vac­cine suc­ces­sor

4 years ago
Pharma

Six months af­ter lift­ing hold, FDA wants to re­voke Pro­tag­o­nist's break­through ther­a­py des­ig­na­tion, biotech says

4 years ago

ICER finds blue­bird's po­ten­tial $2.1M gene ther­a­py cost-ef­fec­tive as FDA ad­comm sched­uled for June

4 years ago
Pharma

FDA ad­dress­es bio­phar­ma's di­ver­si­ty prob­lem with new draft guid­ance

4 years ago
Pharma
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