FDA+ channel feed

Con­gres­sion­al in­quiry in­to 'high­ly atyp­i­cal' FDA-Bio­gen ties ends with damn­ing re­port, no reper­cus­sions

3 years ago
Pharma

TG cross­es the fin­ish line in MS, turn­ing U2 com­po­nent in­to stand­alone drug for biotech's sec­ond ap­proval

3 years ago

FDA grants ap­peal for Arde­lyx chron­ic kid­ney dis­ease drug af­ter Ju­ly 2021 re­jec­tion

3 years ago
R&D

FDA is­sues warn­ing let­ter to South Amer­i­can in­gre­di­ent man­u­fac­tur­er over da­ta prob­lems

3 years ago
Manufacturing

Ac­er, Re­lief win FDA ap­proval for rare meta­bol­ic dis­ease af­ter clear­ing in­spec­tion hur­dles

3 years ago
Pharma

FDA re­jects Ipsen rare-dis­ease drug, more da­ta and time need­ed to re­view

3 years ago
R&D

Up­dat­ed: FDA clears first CD20xCD3 bis­pe­cif­ic, giv­ing Genen­tech leg up in a crowd­ed lym­phoma R&D field

3 years ago
R&D
Pharma

FDA qui­et­ly turns Keytru­da ac­cel­er­at­ed ap­proval for less-fre­quent dos­ing in­to full ap­proval

3 years ago
Pharma

Roche's Actem­ra wins ap­proval for hos­pi­tal­ized Covid pa­tients

3 years ago
Pharma
Coronavirus

Gilead wins ap­proval for long-act­ing HIV in­jec­tion af­ter re­solv­ing vial con­cerns

3 years ago

Vir­ginia Rep. Span­berg­er asks FDA, DEA chiefs to re­spond to Adder­all short­ages

3 years ago
Pharma
Manufacturing

CBER's Pe­ter Marks says Covid-19 shots to mir­ror flu shots: Man­u­fac­tur­ers will be in­ter­change­able

3 years ago
Coronavirus

FDA and EMA ac­cept Pfiz­er’s reg­u­la­to­ry sub­mis­sions for ul­cer­a­tive col­i­tis drug

3 years ago
R&D

Cor­rect­ed: Fac­ing decades in prison, two biotech lead­ers charged with wire and se­cu­ri­ties fraud, ly­ing to in­ves­ti­ga­tors

3 years ago
Pharma
Law

Om­nibus spend­ing bill fea­tures fund­ing to bol­ster the sup­ply chain and site in­spec­tions

3 years ago
Pharma
Manufacturing

Ac­cel­er­at­ed ap­proval re­forms make the cut in year-end gov­ern­ment spend­ing bill

3 years ago
Law

En­tra­da hit with clin­i­cal hold on Duchenne drug

3 years ago

FDA re­ports short­ages for two of Eli Lil­ly's di­a­betes drugs will ex­tend in­to next year

3 years ago
Pharma
Manufacturing

Ab­b­Vie adds de­pres­sion in­di­ca­tion to Vray­lar's la­bel months af­ter Gon­za­lez touts $4B+ peak sales po­ten­tial

3 years ago
Pharma

Wall Street still sees an up­side for rare dis­ease drug de­vel­op­ment as FDA looks to fill knowl­edge gaps

3 years ago

FDA ap­proves Fer­ring's new gene ther­a­py for blad­der can­cer

3 years ago
Cell/Gene Tx

FDA sched­ules Covid-19 vac­cine ad­comm to dis­cuss po­ten­tial mod­i­fi­ca­tions and boost­ers

3 years ago

Biden signs stop­gap fund­ing through next week as ne­go­tia­tors prep for larg­er om­nibus bill

3 years ago
Law

What FDA might con­sid­er as de­lay­ing or deny­ing an in­spec­tion: New guid­ance spells out the specifics

3 years ago
Manufacturing
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