FDA+ channel feed

EMA re­views da­ta on risk of neu­rode­vel­op­men­tal dis­or­ders for chil­dren with fa­thers on val­proate drugs

Last year

FDA ap­proves Ipsen's ul­tra-rare dis­ease drug palo­varotene

Last year
Pharma

Fed­er­al ap­peals court re­stricts ac­cess to abor­tion pill, at­tempt­ing to re­vert back to FDA's 2016 re­stric­tions on the drug

Last year
Law

Flori­da adds ne­glect­ed FOIA re­quests to amend­ed law­suit against FDA over drug im­ports

Last year
Pharma

An­oth­er Eylea com­peti­tor pre­pares to en­ter the ring fol­low­ing pos­i­tive PhI­II read­out

Last year
Pharma

Q&A: FDA's Pe­ter Marks ready to en­cour­age more ac­cel­er­at­ed ap­provals for rare dis­eases

Last year
People

FDA fi­nal­izes 2014 guid­ance on in­formed con­sent in tri­als, with more up­dates com­ing soon

Last year

Bio­con fa­cil­i­ty in Malaysia found to have is­sues once again by the FDA

Last year
Pharma
Manufacturing

FDA pro­mo­tions watch­dog de­liv­ers first warn­ing let­ter of the year to As­traZeneca over Breztri mar­ket­ing

Last year
Pharma
Marketing

Re­vance touts first ther­a­peu­tic in­di­ca­tion for Botox ri­val Daxxi­fy in cer­vi­cal dys­to­nia

Last year
Pharma

Pfiz­er cel­e­brates ac­cel­er­at­ed win for po­ten­tial mul­ti­ple myelo­ma block­buster

Last year
Pharma

FDA ex­tends re­view on Val­ne­va chikun­gun­ya vac­cine by three months

Last year

FDA hands ap­proval to Janssen's BR­CA-pos­i­tive prostate can­cer com­bo tablet

Last year
Pharma

No­vo Nordisk buck­les down on lob­by­ing ef­forts, inch­ing to­ward CMS cov­er­age of obe­si­ty treat­ments

Last year
Pharma

Last re­sort: On­copep­tides for­mal­ly chal­lenges FDA's with­draw­al of can­cer drug's ac­cel­er­at­ed ap­proval

Last year

FDA lays out post­mar­ket­ing ap­proach­es for da­ta col­lec­tion from un­der­rep­re­sent­ed groups

Last year
Pharma

J&J re­ceives fifth FDA nod for treat­ing mul­ti­ple myelo­ma, with boxed warn­ing and REMS in tow

Last year
R&D
Pharma

Galera Ther­a­peu­tics to cut 70% of staff in wake of re­jec­tion for ra­dio­ther­a­py com­pli­ca­tion treat­ment

Last year
Pharma

Genen­tech, Blue­print tout full ap­proval for Gavre­to in rare type of lung can­cer

Last year
Pharma

FDA+ roundup: FDA con­tin­ues to loosen stan­dard of ev­i­dence for nov­el drug ap­provals — JA­MA re­search let­ter

Last year
R&D

DOD taps Val­isure to car­ry out drug qual­i­ty re­views amid gener­ic short­ages, con­cerns

Last year
Manufacturing

Hos­pi­tal groups ask Con­gress to re­form 340B pro­gram, crack down on con­tract phar­ma­cy re­stric­tions

Last year
Pharma

Sage sug­gests job and pipeline cuts af­ter FDA re­jec­tion of ma­jor de­pres­sion pill

Last year
People
Pharma

FDA ap­proves sec­ond ge­o­graph­ic at­ro­phy drug but caps use pe­ri­od, as Astel­las’ Iver­ic looks to spar with Apel­lis

Last year
Pharma
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