FDA+ channel feed

FDA ap­proves Dai­ichi Sanky­o's new first-line AML drug quizar­tinib with boxed warn­ing for heart dis­or­ders

Last year

Af­ter sev­en pa­tient deaths, ADC gets par­tial hold and de­cides to stop Zyn­lon­ta tri­al

Last year
R&D

Hori­zon adds 'se­vere hear­ing im­pair­men­t' warn­ing to block­buster's la­bel

Last year

FTC cau­tions against re­ly­ing on its past PBM ad­vo­ca­cy as in­dus­try push­es back

Last year
Pharma

De­spite Dem op­po­si­tion, House com­mit­tee ad­vances pan­dem­ic pre­pared­ness bill sans drug short­age pro­vi­sions

Last year
Pharma

House Re­pub­li­cans ques­tion FDA's progress on phar­ma in­spec­tions in In­dia and Chi­na

Last year
Manufacturing
Law

CMS pro­pos­es new cov­er­age pol­i­cy for Alzheimer's-re­lat­ed PET scans

Last year
Pharma

In­gre­di­ent man­u­fac­tur­er Cen­taur gets FDA warn­ing over records, sub­stan­dard clean­ing

Last year
Pharma
Manufacturing

Man­u­fac­tur­ers, in­dus­try groups com­ment on FDA’s con­trol over ni­trosamines in drug prod­ucts

Last year
Pharma
Manufacturing

Af­ter year­long de­lay, FDA com­pletes in­spec­tion for No­var­tis, BeiGene's an­ti-PD-1 drug from Chi­na

Last year
R&D

Bi­par­ti­san group of sen­a­tors seeks to elim­i­nate in­ter­change­abil­i­ty des­ig­na­tion for biosim­i­lars

Last year
Law

FDA ap­proves an­oth­er RSV op­tion, this time it's Sanofi and As­traZeneca’s an­ti­body drug for in­fants

Last year
Pharma

FDA cites clean­ing, main­te­nance is­sues at Catal­ent fa­cil­i­ty re­spon­si­ble for Re­gen­eron’s drug re­jec­tion

Last year
People
Manufacturing

House green­lights psy­che­del­ic re­search in NDAA, drug short­age and PBM re­forms to come

Last year
Pharma

GAO of­fers 11 new poli­cies to im­prove re­gen­er­a­tive med­i­cine de­vel­op­ment in new re­port

Last year
Pharma

CMS pro­pos­es cov­er­age for pre-ex­po­sure pro­phy­lax­is reg­i­mens to pre­vent HIV

Last year
Pharma

FDA ap­proves first over-the-counter birth con­trol pill, ex­pect­ed to hit shelves in 2024

Last year
Pharma

FDA drafts new guid­ance on man­u­fac­tur­ing cell and gene ther­a­pies, post­mar­ket tri­al non­com­pli­ance

Last year
Cell/Gene Tx

FDA's top can­cer lead­ers want to shift how com­pan­ion di­ag­nos­tics are reg­u­lat­ed

Last year

Duke re­ceives $50M FDA award to es­tab­lish new re­search cen­ter

Last year

Take­da pulls dengue vac­cine ap­pli­ca­tion af­ter FDA re­quests more da­ta

Last year
Pharma

Xspray Phar­ma hand­ed CRL from US reg­u­la­tors seek­ing more in­for­ma­tion about leukemia treat­ment

Last year
Manufacturing

New pro­vi­sion­al, time-lim­it­ed drug ap­proval path­way: House and Sen­ate rein­tro­duce bi­par­ti­san bill

Last year
Law

No more FDA ad­comm votes? Re­forms brew as new re­search high­lights de­cline in meet­ings

Last year
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