Regulatory channel feed

Once fu­ri­ous over No­var­tis’ da­ta ma­nip­u­la­tion scan­dal, the FDA now says it’s noth­ing they need to take ac­tion on

10 hours ago
Regulatory

As­traZeneca gets a green light on Imfinzi for small-cell lung can­cer — set­ting the stage for a bat­tle with Roche's ...

Yesterday
Pharma
Regulatory

FDA ends CSR pi­lot, plots new ap­proach for dis­clos­ing study re­ports

4 days ago
Regulatory

EMA of­fers method­olog­i­cal con­sid­er­a­tions for tri­als dur­ing Covid-19 pan­dem­ic

5 days ago
Coronavirus
Regulatory

Kept on hold at the FDA, Ipsen scraps a key tri­al and re­vamps R&D path for its trou­bled $1B-plus rare dis­ease drug

5 days ago
R&D
Regulatory

Bris­tol My­ers bags a long-await­ed FDA OK for ozan­i­mod — but the pan­dem­ic will keep it off the mar­ket

5 days ago
Pharma
Regulatory

Af­ter crit­ics lam­bast­ed Gilead for grab­bing the FDA's spe­cial rare drug sta­tus on remde­sivir, they're giv­ing it back

6 days ago
Coronavirus
Pharma

FDA is­sues an­oth­er safe­ty alert re­lat­ed to fe­cal trans­plants, as da­ta sug­gest coro­n­avirus lingers in poop

6 days ago
Coronavirus
Regulatory

BeiGene scram­bles to find new Abrax­ane sup­pli­er as Chi­nese in­spec­tors or­der halt on im­ports, cit­ing Bris­tol My­ers ...

6 days ago
China
Regulatory

The first big hur­dle on the Cel­gene CVR ar­rives to­day. Can Bris­tol My­ers clear a low bar in the mid­dle of a pan­dem­ic?

6 days ago
Regulatory

BP­CIA turns 10: Near­ly 100 drugs be­come bi­o­log­ics

Last week
Regulatory

No sur­prise: Af­ter near unan­i­mous ad­comm, FDA re­jects Eli Lil­ly bid to bring Jar­diance to type 1 pa­tients

Last week
R&D
Regulatory

J&J pitch­es its S1P1 MS drug in­to the reg­u­la­to­ry ring as the com­pe­ti­tion heats up fast

Last week
R&D
Regulatory

FDA un­veils guid­ance for Covid-19 tri­als

Last week
Coronavirus
Regulatory

Con­tract man­u­fac­tur­er: FDA has halt­ed do­mes­tic phar­ma in­spec­tions

2 weeks ago
Coronavirus
Regulatory

FDA of­fers Roche an emer­gency OK for coro­n­avirus test­ing tech — eas­ing a crit­i­cal log­jam

3 weeks ago
Coronavirus
Regulatory

Taint­ed do­na­tions from stool bank reignite safe­ty con­cerns about poop trans­plants

3 weeks ago
R&D
Regulatory

A one-time biotech uni­corn gets slaugh­tered as lead pro­gram is scrapped, high­light­ing lin­ger­ing trou­ble

3 weeks ago
R&D
Regulatory

Coro­n­avirus: WHO de­clares pan­dem­ic, EMA meet­ings go vir­tu­al

3 weeks ago
Regulatory

FDA drafts guid­ance on al­ter­nate elec­tron­ic for­mats, an­nounces sup­port for new da­ta stan­dards

3 weeks ago
Regulatory

Af­ter hit­ting big in mul­ti­ple myelo­ma, J&J, Gen­mab now have a new 'break­through' in NSCLC to boast about

3 weeks ago
Regulatory

Tiny Treve­na re­turns to FDA in sec­ond bid for con­tro­ver­sial opi­oid painkiller

4 weeks ago
Regulatory

FDA re­quires boxed warn­ing for Sin­gu­lair and its gener­ics

4 weeks ago
Pharma
Regulatory

In­di­vid­u­al­ized ther­a­pies: CBER di­rec­tor dis­cuss­es chal­lenges, reg­u­la­to­ry ap­proach

4 weeks ago
Regulatory
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