FDA+ channel feed

ICER push­es back on FDA's po­ten­tial con­ver­sion of Sarep­ta's gene ther­a­py to full ap­proval

Last year
Pharma
Cell/Gene Tx

FDA asks for more da­ta on Dupix­ent in COPD in move that could de­lay a de­ci­sion

Last year
R&D
Pharma

FDA de­ci­sion on Sarep­ta’s Duchenne gene ther­a­py could come ear­li­er than ex­pect­ed

Last year
R&D
Cell/Gene Tx

Sen­a­tor al­leges GSK is shirk­ing its com­mit­ment to low­er in­haler costs

Last year
Pharma

Neu­ro­crine wins ap­proval of In­grez­za 'sprin­kle' for­mu­la­tion for pa­tients with trou­ble swal­low­ing

Last year
Pharma

FTC tar­gets more drug patents, go­ing af­ter obe­si­ty, di­a­betes and asth­ma med­ica­tions

Last year
Pharma

FDA asks for pub­lic in­put on ad­vi­so­ry com­mit­tee re­forms

Last year
Pharma

Unit­ed­Health CEO re­veals cy­ber­at­tack ori­gins ahead of Change Health­care hear­ings

Last year
Health Tech

FDA con­verts Pfiz­er's Tiv­dak to full ap­proval in cer­vi­cal can­cer

Last year
Pharma

FDA fi­nal­izes long-await­ed rule to bring lab tests un­der its purview

Last year
Pharma
Diagnostics

No­vo Nordisk's once-week­ly in­sulin will face FDA ad­comm in May, fol­low­ing re­view ex­ten­sion

Last year
Pharma

Prime Med­i­cine re­ceives FDA clear­ance to run first prime edit­ing clin­i­cal tri­al

Last year
R&D
Cell/Gene Tx

FDA ap­proves X4 Phar­ma­ceu­ti­cal­s' pill for ul­tra-rare im­mun­od­e­fi­cien­cy dis­ease

Last year
Pharma

CHMP rec­om­mends eight new drug ap­provals, six la­bel ex­pan­sions

Last year
Pharma

FDA green­lights la­bel up­date to Gilead­'s Bik­tarvy to in­clude more da­ta in preg­nant peo­ple

Last year
Pharma

Sanders press­es phar­ma lead­ers to change stance on Pan­dem­ic Ac­cord pro­pos­als

Last year
Pharma

Up­dat­ed: FDA ap­proves Pfiz­er’s he­mo­phil­ia B gene ther­a­py, with $3.5M price tag

Last year
Pharma
Cell/Gene Tx

In rare move, Colom­bia is­sues com­pul­so­ry li­cense for HIV med­i­cine in ef­fort to ex­pand ac­cess

Last year
Pharma

FDA re­vis­es guid­ance on biosim­i­lar pro­mo­tion­al la­bels and ad­ver­tis­ing

Last year
Marketing

FDA's bi­o­log­ics chief Pe­ter Marks pre­views ac­cel­er­at­ed ap­proval guid­ance

Last year
R&D
Pharma

No­var­tis brings Lu­tathera to ado­les­cents with rare can­cer in first for ra­di­oli­gand class

Last year
Pharma

FDA gives ac­cel­er­at­ed ap­proval to Day One’s tar­get­ed treat­ment for most com­mon brain tu­mor in kids

Last year
Pharma

FDA ap­proves Im­mu­ni­ty­Bio's blad­der can­cer ther­a­py com­bo

Last year

FDA hands CRL to Abeon­a's rare skin dis­ease cell ther­a­py

Last year
Manufacturing
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