Cell/Gene Tx channel feed

FDA widens Sarep­ta’s Duchenne gene ther­a­py la­bel to old­er boys in sig­nif­i­cant ex­pan­sion of use

Last year
Pharma
FDA+

In­ter­na­tion­al so­ci­ety crit­i­cizes Utah law for per­mit­ting un­ap­proved stem cell ther­a­pies

Last year
Pharma
FDA+

FDA loosens side ef­fect re­port­ing re­quire­ments for some CAR-T ther­a­pies

Last year
Pharma
FDA+

Up­dat­ed: Taysha teas­es ear­ly gene ther­a­py da­ta for Rett syn­drome

Last year
R&D

Au­toim­mune CAR-T da­ta dump: Kyver­na, Ca­balet­ta shares fall af­ter un­veil­ing ear­ly-stage re­sults

Last year
R&D

Ul­tragenyx to seek ac­cel­er­at­ed ap­proval for rare dis­ease gene ther­a­py

Last year
FDA+

Pfiz­er’s Duchenne mus­cu­lar dy­s­tro­phy gene ther­a­py fails Phase 3 tri­al

Last year
R&D

BioN­Tech co-founder Özlem Türe­ci on ‘hip’ AD­Cs and the pow­er of com­bo ther­a­pies

Last year
People
R&D

Up­dat­ed: What the first five par­tic­i­pants for FDA's Op­er­a­tion Warp Speed for rare dis­eases are tack­ling

Last year
FDA+

In­tel­lia plots Phase 3 study and a 2026 FDA sub­mis­sion af­ter CRISPR ther­a­py cuts swelling at­tacks by 98%

Last year
R&D

Io­vance's TIL ther­a­py plus Keytru­da show durable treat­ment ef­fect in melanoma, but ac­cess re­mains a ques­tion

Last year
R&D

Adap­ti­m­mune taps Gala­pa­gos to de­cen­tral­ize man­u­fac­tur­ing of sol­id tu­mor T cell ther­a­py

Last year
Deals
Manufacturing

Ul­tragenyx touts Phase 3 win for gene ther­a­py in rare glyco­gen stor­age dis­or­der

Last year
R&D

Bris­tol My­er­s' CAR-T ther­a­py Breyanzi adds new ap­proval in man­tle cell lym­phoma

Last year
Pharma
FDA+

Flush with cash, No­vo Nordisk Foun­da­tion now plans to rein­vest some GLP-1 prof­its in­to re­gen­er­a­tive med­i­cines

Last year
R&D

Ori Biotech, Cy­ti­va sep­a­rate­ly un­veil tech to ac­cel­er­ate cell ther­a­py pro­duc­tion

Last year
Manufacturing

New York start­up rais­es $33M for fer­til­i­ty treat­ment based on George Church’s stem cell re­search

Last year
Financing

FDA de­tails new 'plat­form tech­nol­o­gy' process that could ac­cel­er­ate cell and gene ther­a­py ap­provals

Last year
FDA+

Sec­ond en­gi­neered B cell ther­a­py en­ters the clin­ic, promis­ing to do in he­mo­phil­ia B what gene ther­a­pies can't

Last year
R&D
FDA+

Re­NA­gade is ac­quired by RNA ri­val a year af­ter megaround-backed launch

Last year
Deals

Mer­ck KGaA makes $600M bet to boost man­u­fac­tur­ing for vi­ral vec­tors

Last year
Deals
Manufacturing

FDA's Marks, Wood­cock talk reg­u­la­to­ry flex­i­bil­i­ty for new rare dis­ease drugs

Last year
FDA+

Evotec ends gene ther­a­py busi­ness, shuts down fa­cil­i­ty in Aus­tria

Last year
Pharma
Manufacturing

Bris­tol My­er­s' CAR-T ther­a­py Breyanzi adds fol­lic­u­lar lym­phoma to list of ap­provals

Last year
Pharma
FDA+
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