FDA+ channel feed

In­tas Phar­ma­ceu­ti­cal­s' In­di­an fa­cil­i­ty hit with FDA warn­ing let­ter, placed on im­port alert

Last year
Manufacturing

FDA to make de­ci­sion about Karuna's schiz­o­phre­nia drug by next Sep­tem­ber

Last year
R&D

FDA opens re­view of CAR-T safe­ty af­ter iden­ti­fy­ing 19 cas­es of post-treat­ment blood can­cer

Last year
Pharma
Cell/Gene Tx

Aldeyra's dry eye drug gets a re­jec­tion from the FDA

Last year

Spring­Works Ther­a­peu­tics ready to launch new­ly-ap­proved desmoid tu­mor treat­ment af­ter three-month de­lay

Last year
Pharma

Marks: FDA open to us­ing sin­gle-arm stud­ies for ac­cel­er­at­ed ap­proval of rare dis­ease gene ther­a­pies

Last year
Cell/Gene Tx

FDA to SCO­TUS: Set­ting the mifepri­s­tone reg­u­la­tions clock back to 2016 is 'un­jus­ti­fied'

Last year
Law

FDA warns Genen­tech clin­i­cal in­ves­ti­ga­tor work­ing on pre­ven­tive flu an­tivi­ral tri­al

Last year

FDA warns Cipla's al­buterol in­haler plant af­ter thou­sands of com­plaints

Last year
R&D
Manufacturing

Im­prop­er Or­ange Book list­ings harm com­pe­ti­tion, FTC says in am­i­cus brief to an­titrust suit

Last year
Pharma
Law

Bernie Sanders in­vites CEOs of J&J, Mer­ck, Bris­tol My­ers to tes­ti­fy on drug pric­ing

Last year
People
Pharma

As­cendis Phar­ma's hy­poparathy­roidism drug scores Eu­ro­pean ap­proval af­ter re­fil­ing in the US

Last year
Pharma

New FDA rule for phar­ma ad­ver­tise­ments re­quires side ef­fects to be ex­plained clear­ly

Last year
Marketing

Sen­ate De­moc­rats press As­traZeneca, Sanofi on RSV an­ti­body short­age

Last year
Pharma

Bris­tol My­ers and 2sev­en­ty bio say FDA de­layed CAR-T ther­a­py de­ci­sion

Last year
Cell/Gene Tx

Pfiz­er, Astel­las clinch ex­pand­ed ap­proval for Xtan­di in ear­li­er line of prostate can­cer

Last year
R&D
Pharma

Biden taps Van­der­bilt’s Kim­ryn Rath­mell to suc­ceed Bertag­nol­li as the NI­H's can­cer chief

Last year
People
Pharma

Mer­ck notch­es 38th ap­proval for Keytru­da, sev­enth in­di­ca­tion for gas­troin­testi­nal can­cer

Last year
Pharma

As­traZeneca lands FDA ap­proval for AKT in­hibitor in bio­mark­er-de­fined breast can­cer sub­set

Last year
Pharma

Slew of House De­moc­rats urge FDA, HHS to pre­serve ac­cess to miso­pros­tol, methotrex­ate

Last year
Pharma

'Well un­der­way': FDA calls for faster con­fir­ma­to­ry tri­als for ac­cel­er­at­ed ap­provals

Last year
Pharma

FDA's Janet Wood­cock to re­tire in ear­ly 2024

Last year
People

FDA hands down ap­proval for Bris­tol My­er­s' lung can­cer drug from Turn­ing Point buy­out

Last year
Pharma

In a world first, Ver­tex, CRISPR win UK ap­proval for CRISPR-edit­ed ther­a­py to treat sick­le cell dis­ease, be­ta-tha­lassemia

Last year
Cell/Gene Tx
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