FDA+ channel feed

EMA safe­ty com­mit­tee ramps up warn­ing against use of top­i­ra­mate dur­ing preg­nan­cy

4 weeks ago
Pharma

Lil­ly, No­vo, Sanofi face pres­sure from law­mak­ers to clar­i­fy low-cost in­sulin pro­grams

4 weeks ago
Pharma

FDA aims to bet­ter in­cen­tivize qual­i­ty drug man­u­fac­tur­ing in new pro­gram

4 weeks ago
Manufacturing

Bot­u­lism risk: FDA de­liv­ers warn­ing let­ter to Gadal Labs for site mak­ing OTC pe­di­atric drugs 

4 weeks ago
Manufacturing

De­mo­c­rat law­mak­ers call on FDA to take steps to pre­vent mis­use of Or­ange Book

4 weeks ago
Pharma

FDA+ roundup: FDA is­sues fi­nal guid­ance on use of re­al-world ev­i­dence

4 weeks ago
R&D
Pharma

FDA re­ject­ed Out­look Ther­a­peu­tic­s' Lu­cen­tis ri­val, and the com­pa­ny's stock plunged

4 weeks ago
Pharma

Af­ter de­lay, Abeona aims for fall FDA sub­mis­sion for rare skin con­di­tion cell ther­a­py

4 weeks ago
R&D

Eye drop pro­duc­er KC Phar­ma­ceu­ti­cals re­ceives FDA warn­ing let­ter

4 weeks ago
Manufacturing

Bris­tol My­ers se­cures FDA la­bel ex­pan­sion for ane­mia drug Re­blozyl

4 weeks ago
Pharma

Great Britain ap­proves sub­cu­ta­neous Tecen­triq weeks ahead of ex­pect­ed US de­ci­sion

4 weeks ago
Pharma

Geor­gia law­mak­ers send let­ter to FDA over con­tin­ued can­cer drug short­age

4 weeks ago
Manufacturing

Up­dat­ed: US se­lects first 10 drugs sub­ject to Medicare price ne­go­ti­a­tions

4 weeks ago
Pharma

FDA to hold off on en­forc­ing some parts of ma­jor sup­ply chain law un­til 2024

4 weeks ago
Pharma

FDA pub­lish­es On­copep­tides’ with­draw­al ap­peal for Swedish biotech’s can­cer drug Pepax­to

5 weeks ago
Pharma

As­traZeneca dis­putes IRA’s or­phan drug pro­vi­sions in lat­est le­gal chal­lenge to the law

5 weeks ago
Pharma
Law

FDA ap­proves San­doz’s na­tal­izum­ab biosim­i­lar, like­ly putting a damper on Bio­gen’s Tysabri sales

5 weeks ago
Pharma

CMS’ Medicare ne­go­ti­a­tion list is com­ing next week. Here’s what to ex­pect

Last month
Pharma

FDA ad­vi­so­ry com­mit­tee will meet next month to dis­cuss Intar­ci­a's di­a­betes drug

Last month
Pharma

Biden awards $24M to de­vel­op mR­NA tech tar­get­ing can­cer, oth­er dis­eases

Last month
R&D
Pharma

FDA warns Ama­zon and Wal­mart over sale of un­ap­proved prod­uct

Last month
Pharma

Op­er­a­tion Warp Speed re­dux: HHS awards $1.4B to de­vel­op next-gen Covid-19 drugs and vac­cines

Last month
Pharma

CMS lays out how se­niors can pay for drugs on a month­ly ba­sis in 2025 and be­yond

Last month
Pharma

Ful­crum’s sick­le cell hold re­solved, and tri­al will now fo­cus on more se­vere pa­tients

Last month
R&D
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