FDA+ channel feed

CBO: Con­gres­sion­al ac­tion on drug prices will make R&D spend­ing less at­trac­tive

5 years ago
Pharma

Scoop: Fer­ring, Black­stone’s $570M gene ther­a­py ven­ture has im­plod­ed af­ter CMC is­sues stymied a once high-pro­file quest

5 years ago
Manufacturing

Trou­ble brew­ing for Proven­tion? Shares crater af­ter FDA says their teplizum­ab drug pro­file does­n't match that from for­mer own­er Eli Lil­ly

5 years ago

FDA in­spec­tion of Emer­gent’s Bal­ti­more site in 2020 rais­es new ques­tions

5 years ago
Manufacturing

Se­ries of JAK in­hibitor de­lays may sig­nal an up­com­ing FDA ad­comm

5 years ago
Pharma

For­mer In­di­v­ior med­ical lead who pled guilty to false opi­oid mar­ket­ing now seeks FDA hear­ing to es­cape de­bar­ment

5 years ago
Pharma

Re­call re­port: A-S pulls near­ly 200,000 ac­eta­minophen bot­tles off shelves; Apo­tex yanks AD­HD med

5 years ago
Pharma
Manufacturing

PDU­FA VII ne­go­ti­a­tions near fin­ish line with plans to re­vamp CBER and staff up

5 years ago
Pharma

Eye­ing stan­dard of care sta­tus in 3rd-line TNBC, Gilead nails down full OK for Trodelvy with a slight­ly broad­er la­bel

5 years ago
Pharma

EMA finds link be­tween ‘very rare’ but some­times fa­tal blood clots and As­traZeneca vac­cine

5 years ago
Coronavirus

FDA and EMA sig­nal an op­por­tu­ni­ty to har­mo­nize ad­vanced ther­a­py reg­u­la­tions

5 years ago
Cell/Gene Tx

FDA push­es eczema de­ci­sion for Eli Lil­ly's Olu­mi­ant, Pfiz­er's abroc­i­tinib back 3 months — rais­ing more ques­tions for the JAK class

5 years ago
Pharma

Fi­bro­Gen shares take a beat­ing as CEO re­veals safe­ty da­ta ma­nip­u­la­tion for its block­buster con­tender rox­adu­s­tat

5 years ago
R&D

Can em­ploy­ers man­date Covid-19 vac­cines un­der emer­gency au­tho­riza­tions? It’s com­pli­cat­ed

5 years ago
Coronavirus

Eu­ro­pean Com­mis­sion preps for ma­jor over­haul of phar­ma leg­is­la­tion

5 years ago
Pharma

MHRA kicks off new ac­cel­er­at­ed drug ap­proval path­way with ‘in­no­va­tion pass­ports’

5 years ago
Pharma

FDA un­veils top 5 pri­or­i­ties for re­work­ing its Covid-19 re­sponse mov­ing for­ward

5 years ago
Coronavirus

An­oth­er day, an­oth­er de­lay: FDA push­es back a sec­ond re­view for Ab­b­Vie's Rin­voq, this time in atopic der­mati­tis

5 years ago

Su­per­nus bat­tles back from CRL, scor­ing the FDA's ap­proval for non-stim­u­lant AD­HD med Qel­bree

5 years ago

Aca­dia preps for bat­tle as the FDA re­jects a po­ten­tial block­buster ap­pli­ca­tion

5 years ago

Why the Biden ad­min­is­tra­tion might not want to be con­tent with just an act­ing FDA com­mis­sion­er

5 years ago
Pharma

Bris­tol My­ers faces $1B+ tax fight af­ter ac­ci­den­tal dis­clo­sure re­veals al­leged off­shore patents scheme — re­port

5 years ago
Pharma

In high­ly un­usu­al op-ed, 3 ad­u­canum­ab ad­comm mem­bers again call on FDA to re­ject Bio­gen's Alzheimer's drug

5 years ago

Sanofi keeps nip­ping at J&J's heels as Sar­clisa notch­es new FDA ap­proval in mul­ti­ple myelo­ma

5 years ago
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