FDA+ channel feed

With piv­otal da­ta on its Covid-19 an­ti­body in hand, As­traZeneca pre­pares for a mad dash to the FDA

4 years ago
Coronavirus

FDA ap­proves Mirum Phar­ma's first treat­ment for rare pe­di­atric bile duct dis­ease

4 years ago
Pharma

FDA+ guid­ance roundup: Ben­e­fit-risk as­sess­ments, RWE to sup­port reg­u­la­to­ry de­ci­sion-mak­ing, and more

4 years ago

Ab­b­Vie clos­es in on Bio­haven with new mi­graine pre­ven­tion OK for oral CGRP drug

4 years ago
Pharma

FDA calls for re­peat bioe­quiv­a­lence stud­ies af­ter un­cov­er­ing 'in­valid' da­ta from two In­di­an CROs

4 years ago
Outsourcing

Tur­moil at CBER: Pe­ter Marks grabs con­trol of FDA's Of­fice of Vac­cines ahead of 2 key ca­reer leader de­par­tures

4 years ago
Coronavirus

Seiz­ing Aduhelm prece­dent, Bio­gen, Ei­sai get the ball rolling on an­oth­er ac­cel­er­at­ed Alzheimer's ap­proval

4 years ago

Af­ter pump­ing the brakes on their An­gel­man syn­drome study, Ul­tragenyx and GeneTx are back in the race

4 years ago

New ARIA cas­es dog Bio­gen's Aduhelm launch in an­oth­er po­ten­tial blow to block­buster hopes — an­a­lyst

4 years ago

CDC di­rec­tor over­rules ad­vi­sors on boost­ers, rec­om­mend­ing third shots for at-risk work­ers

4 years ago

FDA's can­cer drug ad­vi­sors will re­view 2 more dan­gling ac­cel­er­at­ed ap­provals for mul­ti­ple myelo­ma, leukemia

4 years ago

Fol­low­ing con­tro­ver­sial Aduhelm ap­proval, DC-based neu­rol­o­gy cen­ter bans Bio­gen rep­re­sen­ta­tives from its of­fices — re­port

4 years ago
Pharma

Mitch Mc­Connell, top Re­pub­li­cans ques­tion Biden on get­ting ahead of FDA on Covid-19 boost­ers

4 years ago
Coronavirus

In­cyte's rux­oli­tinib scores its sec­ond ap­proval in two days, this time in chron­ic graft-ver­sus-host dis­ease

4 years ago

The FDA ob­jects to biotech bil­lion­aire Bob Dug­gan’s PhI­II plans — and he’s not budg­ing

4 years ago

FDA+ roundup: Bs­U­FA III ready for show­time, court tells FDA to re-work com­pound­ing plan, new guid­ance up­dates and more

4 years ago

In­cyte nabs ap­proval of top­i­cal rux­oli­tinib in atopic der­mati­tis, but gets slapped with JAK warn­ing

4 years ago

When ef­fi­ca­cy is bor­der­line: FDA needs to get more con­sis­tent on close-call drug ap­provals, agency-fund­ed re­search finds

4 years ago

Ver­ri­ca hits an­oth­er bump in the road with CMO re­lat­ed let­ter from FDA

4 years ago
Manufacturing

FDA hands ac­cel­er­at­ed nod to Seagen, Gen­mab's so­lo ADC in cer­vi­cal can­cer, but com­bo stud­ies look even more promis­ing

4 years ago

Ex­elix­is pulls a sur­prise win in thy­roid can­cer just days ahead of fi­nal Cabome­tyx read­out

4 years ago
R&D

Skin tu­mors in mice force Pro­tag­o­nist to halt lead pro­gram, crush­ing stock

4 years ago

The biggest ques­tions fac­ing gene ther­a­py, the XLMTM com­mu­ni­ty, and Astel­las af­ter fourth pa­tient death

4 years ago
Cell/Gene Tx

Take­da scores a win for a rare type of lung can­cer, gear­ing up for a show­down with J&J

4 years ago
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