FDA+ channel feed

Two new drugs get pos­i­tive rec­om­men­da­tions from EMA com­mit­tee, while two oth­ers get thumbs-down

Last year
Pharma

Com­pe­ti­tion en­force­ment led to fair­er prices, in­no­v­a­tive prod­ucts — EC re­port

Last year
Pharma

Re­mote man­u­fac­tur­ing as­sess­ments: FDA re­vis­es draft guid­ance to in­clude new­ly ex­pand­ed pow­ers

Last year
Manufacturing

As PBMs face threats in Wash­ing­ton, in­dus­try trade group poured mil­lions more in­to lob­by­ing

Last year
Pharma

‘I think we will have the votes’: Sanders gears up to sub­poe­na CEOs of J&J, Mer­ck to tes­ti­fy on drug prices

Last year
Pharma

Fol­low­ing CAR-T safe­ty la­bel changes, FDA of­fi­cials share new de­tails about sec­ondary can­cer cas­es

Last year
Pharma
Cell/Gene Tx

FDA up­dates Gilead­'s la­bel for CAR-T Tecar­tus with new boxed warn­ing for sec­ondary can­cer

Last year
Pharma
Cell/Gene Tx

Phar­ma com­pa­nies to re­main mum on CM­S' ini­tial of­fers next week for the first year of IRA ne­go­ti­a­tions

Last year
Law

CMC con­cerns lead to FDA re­jec­tion of Ther­at­e­ch­nolo­gies’ con­cen­trat­ed ver­sion of lipody­s­tro­phy drug for HIV pa­tients

Last year
Manufacturing

Up­dat­ed: Gilead’s Tecar­tus dropped from list of CAR-Ts with up­dat­ed boxed warn­ings

Last year
Pharma
Cell/Gene Tx

Bi­par­ti­san group of law­mak­ers seeks to reign in phar­ma patent thick­ets with new bill

Last year
Pharma

Up­dat­ed: FDA’s safe­ty re­view on CAR-Ts cul­mi­nates in new boxed warn­ings of sec­ondary can­cer

Last year
Pharma
Cell/Gene Tx

Au­to­lus eyes No­vem­ber for po­ten­tial US ap­proval of Tecar­tus ri­val

Last year
Pharma
Cell/Gene Tx

For clin­i­cian-ad­min­is­tered drugs, re­searchers find no as­so­ci­a­tion be­tween price in­creas­es and OOP cost in­creas­es

Last year

FDA high­lights pri­or­i­ty re­view vouch­ers re­deemed as reau­tho­riza­tion lingers in Con­gress

Last year
Pharma

No­var­tis' TV ad for breast can­cer drug Kisqali draws un­ti­tled let­ter from FDA

Last year
Pharma
Marketing

J&J wins full ap­proval for blad­der can­cer drug

Last year
Pharma

De­San­tis, John­son raise flags around Covid boost­ers as FDA main­tains that they're safe and ef­fec­tive

Last year
Pharma

As­traZeneca's rare blood dis­or­der pill ap­proved in Japan

Last year
Pharma

As­traZeneca, Boehringer In­gel­heim, GSK de­fend patent list­ings as Klobuchar amps up pres­sure

Last year
Pharma

The Supreme Court could over­turn the Chevron doc­trine. Here’s how that could hurt the FDA

Last year
Pharma
Law

Sat­suma's nasal mi­graine can­di­date re­ject­ed by FDA over CMC is­sues 

Last year
Manufacturing

FDA+ roundup: Sen. Tillis goes af­ter Biden ad­min­is­tra­tion for sup­port­ing march-in rights

Last year
Pharma

On­col­o­gy drugs lead 2023 new med­i­cines in Eu­rope — EMA re­port

Last year
Pharma
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