FDA+ channel feed

As­traZeneca dis­putes IRA’s or­phan drug pro­vi­sions in lat­est le­gal chal­lenge to the law

Last year
Pharma
Law

FDA ap­proves San­doz’s na­tal­izum­ab biosim­i­lar, like­ly putting a damper on Bio­gen’s Tysabri sales

Last year
Pharma

CMS’ Medicare ne­go­ti­a­tion list is com­ing next week. Here’s what to ex­pect

Last year
Pharma

FDA ad­vi­so­ry com­mit­tee will meet next month to dis­cuss Intar­ci­a's di­a­betes drug

Last year
Pharma

Biden awards $24M to de­vel­op mR­NA tech tar­get­ing can­cer, oth­er dis­eases

Last year
R&D
Pharma

FDA warns Ama­zon and Wal­mart over sale of un­ap­proved prod­uct

Last year
Pharma

Op­er­a­tion Warp Speed re­dux: HHS awards $1.4B to de­vel­op next-gen Covid-19 drugs and vac­cines

Last year
Pharma

CMS lays out how se­niors can pay for drugs on a month­ly ba­sis in 2025 and be­yond

Last year
Pharma

Ful­crum’s sick­le cell hold re­solved, and tri­al will now fo­cus on more se­vere pa­tients

Last year
R&D

Pfiz­er's ma­ter­nal RSV vac­cine ap­proved to help pro­tect new­borns

Last year
Pharma

Spring­Works fix­es 'mi­nor da­ta han­dling er­ror' af­ter March Form 483 for tri­al site linked to up­com­ing PDU­FA

Last year

Slynd birth con­trol drug­mak­er Ex­eltis hit with FDA let­ter over mis­lead­ing so­cial me­dia pro­mo­tion

Last year
Marketing

FDA sets Oc­to­ber ad­comm to dis­cuss full ap­proval for Am­gen’s Lumakras to treat sec­ond-line lung can­cer

Last year
Pharma

FDA puts par­tial hold on Gilead’s CD47 hope­ful in AML

Last year
R&D

FDA ap­proves high dose of Re­gen­eron's eye treat­ment Eylea in quick bounce­back from June re­jec­tion

Last year
Pharma

FDA ap­proves Re­gen­eron's an­ti­body for rare im­mune dis­ease, re­solves man­u­fac­tur­ing is­sues for afliber­cept

Last year
Pharma

AARP, in am­i­cus brief, ar­gues that CMS ne­go­ti­at­ing drug prices is in the pub­lic in­ter­est

Last year
Pharma

DOJ plans to take mifepri­s­tone chal­lenge to the Supreme Court

Last year
Pharma
Law

FDA is­sues rare no­tice of non­com­pli­ance for not re­port­ing clin­i­cal tri­al re­sults

Last year

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
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