FDA+ channel feed

Crunch time for FDA user fees as reau­tho­riza­tion looks to hitch a ride on short-term spend­ing bill

3 years ago

Re­tir­ing Re­pub­li­can sen­a­tor lam­basts Biden ap­pointees' re­sponse to mon­key­pox out­break

3 years ago
Law

Still leery about an­i­mal deaths, FDA lifts a full hold on Friedre­ich’s atax­ia drug — but there’s a big con­di­tion

3 years ago

Gov­ern­ment-paid ex­perts help­ing in­dus­try at the ta­ble with FDA? Agency spells out guardrails

3 years ago

New gener­ics save pa­tients bil­lions per year, ac­cord­ing to FDA re­port

3 years ago
Pharma

Form 483 un­masks man­u­fac­tur­ing is­sues at Alvotech be­fore its CRL, and one for Au­robindo too

3 years ago
Pharma
Manufacturing

Biotech-backed non­prof­it joins with FDA to stan­dard­ize process for sub­mit­ting in vit­ro phar­ma­col­o­gy da­ta

3 years ago

'Re­al­ly in­clude every­one in the tri­al': A Q&A with the pro­to­col chair of the PhI­II mon­key­pox an­tivi­ral study

3 years ago
R&D
Pharma

Im­ple­ment­ing 'Right-to-Try': FDA sig­nals like­li­hood of on­ly min­i­mal man­u­fac­tur­er par­tic­i­pa­tion

3 years ago
Pharma

FDA sched­ules joint ad­vi­so­ry com­mit­tee meet­ing to con­sid­er first over-the-counter birth con­trol pill

3 years ago
Pharma

Bio­Marin says PhI­II gene ther­a­py study par­tic­i­pan­t's can­cer is un­re­lat­ed to ther­a­py

3 years ago
Cell/Gene Tx

FDA hires new vac­cine di­rec­tor, a year af­ter two se­nior lead­ers quit in protest

3 years ago
Coronavirus

Biden turns to biotech for his in­au­gur­al ARPA-H di­rec­tor

3 years ago
People

Man­u­fac­tur­ers sound off on FDA drug re­port­ing guid­ance, point­ing to chal­lenges and rec­om­men­da­tions

3 years ago
Pharma
Manufacturing

Col­orado to seek FDA ap­proval by fall on Cana­di­an drug im­ports

3 years ago
Pharma

Am­gen's Neu­las­ta gains an­oth­er biosim­i­lar com­peti­tor as sales slip

3 years ago

Ad­comm votes 7-2 in fa­vor of Amy­lyx's ALS drug on sec­ond take. But first the co-CEOs had to make a pledge

3 years ago
Pharma

On the heels of un­prompt­ed EMA re­view of Covid drug, FDA sched­ules ad­comm for po­ten­tial EUA

3 years ago
Coronavirus

Form 483 re­veals spore con­t­a­m­i­na­tion at a South Ko­re­an man­u­fac­tur­ing site last year

3 years ago
Pharma
Manufacturing

In­te­gral Mol­e­c­u­lar's off-tar­get pro­tein bind­ing ar­ray nabs first spot in FDA pi­lot to speed new drug de­vel­op­ment tools

3 years ago
R&D

Eight years lat­er, FDA re­vis­es draft guid­ance on pe­di­atric clin­i­cal phar­ma­col­o­gy stud­ies

3 years ago

As­traZeneca ex­pands its block­buster Imfinzi fran­chise with new ap­proval in bil­iary tract can­cer

3 years ago
Pharma

Up­dat­ed: Athi­ra plots an Alzheimer's come­back af­ter scan­dal, PhII fail — and hints at pos­si­ble ac­cel­er­at­ed ap­proval pitch

3 years ago
R&D

Af­ter se­ri­ous side ef­fect, Sarep­ta and FDA re­align on next-gen Duchenne drug with tri­al hold lift­ed

3 years ago
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