FDA+ channel feed

Ozem­pic la­bel ex­pand­ed to in­clude re­duced risk of wors­en­ing kid­ney dis­ease

3 months ago
Pharma

One Feb­ru­ary FDA ad­comm meet­ing is de­layed, an­oth­er can­celed

3 months ago

Semaglu­tide, tirzepatide com­pounder hit with FDA warn­ing let­ter 

3 months ago
Manufacturing

The RFK ques­tion: Trump's HHS nom­i­nee splits bio­phar­ma be­fore mo­ment of truth

3 months ago
People

Sarep­ta shares two-year DMD study da­ta that could in­form Eu­ro­pean ap­proval de­ci­sion

3 months ago
R&D
Pharma

Trump blog: Fed­er­al agen­cies must give jobs back to fired pro­ba­tion­ary work­ers, judge rules

3 months ago
Pharma
In Focus

Ei­sai and Bio­gen win ap­proval for once-month­ly Leqem­bi main­te­nance dos­ing

3 months ago
Pharma

Up­com­ing PDU­FA dates may be en­snared by Trump's pause at HHS, an­a­lyst says

4 months ago

As an­oth­er Trump term gets un­der­way, phar­ma ad­vi­sors get com­fort­able with un­cer­tain­ty

4 months ago
Pharma

Te­va, Astel­las plan to par­tic­i­pate in IRA drug price ne­go­ti­a­tions

4 months ago
Pharma

As­traZeneca ex­ec stress­es Calquence's patent life ahead of next Medicare ne­go­ti­a­tions

4 months ago
Pharma

Van­da los­es con­sti­tu­tion­al fight over FDA's drug talks with com­peti­tors

4 months ago
Pharma
Law

RFK Jr. says he’ll di­vest in­ter­ests in CRISPR Ther­a­peu­tics if con­firmed for HHS chief

4 months ago
Law

J&J's Spra­va­to wins ex­pand­ed la­bel for de­pres­sion as sin­gu­lar treat­ment

4 months ago
Pharma

Sanofi says no sup­ply in­ter­rup­tions af­ter land­ing FDA warn­ing let­ter for US site

4 months ago
Manufacturing

Ex­it­ing Medicare di­rec­tor ex­pects cur­rent law to guide next price ne­go­ti­a­tions

4 months ago
People
Pharma

FDA ap­proves As­traZeneca and Dai­ichi Sankyo’s ADC for breast can­cer de­spite lack of sur­vival ben­e­fit

4 months ago
R&D

De­part­ing FDA com­mis­sion­er: 'We're los­ing the bat­tle on mis­in­for­ma­tion'

4 months ago
People

FDA re­jects Atara's cell ther­a­py for rare trans­plant com­pli­ca­tion, stock craters

4 months ago
Cell/Gene Tx

Eli Lil­ly's Omvoh earns FDA ap­proval for Crohn's dis­ease

4 months ago
Pharma

FDA ex­plains why it re­ject­ed Van­da's stom­ach drug in late 2024

4 months ago

HHS in­spec­tor gen­er­al rais­es con­cerns over three FDA ac­cel­er­at­ed ap­provals

4 months ago

BIO CEO plans to join FDA mod­ern­iza­tion ad­vi­so­ry board un­der Trump ad­min­is­tra­tion

4 months ago

FDA ad­comm votes to sup­port Seik­a­gaku's her­ni­at­ed disc in­jec­tion

4 months ago
Pharma
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