Regulatory channel feed

An­oth­er record year for gener­ic drug ap­provals but ques­tions on com­pe­ti­tion re­main

48 minutes ago
Regulatory

De­spite wor­ries trig­gered by im­bal­ance of deaths, Sh­ionogi's an­tibi­ot­ic clears FDA pan­el vote

1 hour ago
Regulatory

Pa­tient ex­pe­ri­ence da­ta: Sanofi re­searchers call for more con­sis­ten­cy from FDA

2 days ago
Pharma
Regulatory

In re­ver­sal, NICE backs Rubra­ca af­ter Clo­vis agrees to a price cut

6 days ago
Pharma
Regulatory

Rare dis­ease clin­i­cal tri­als: FDA awards $15M in grants

Last week
R&D
Regulatory

FDA ap­proves drug for rare con­di­tion that trig­gers in­tense pain from light ex­po­sure

Last week
R&D
Regulatory

Is FDA too lax with its drug ap­proval stan­dards? Se­nior FDA of­fi­cials dis­cuss

Last week
Regulatory

Dif­ferin mak­er Gal­der­ma wins FDA ap­proval for a new retinoid for ac­ne

Last week
Pharma
Regulatory

Gilead scores PrEP ap­proval for De­scovy — kick­ing off mar­ket­ing push be­fore Tru­va­da gener­ics swarm

Last week
Pharma
Regulatory

In an un­usu­al move, ICER re­scinds draft re­port on JAK drugs for rheuma­toid arthri­tis to re­vise its mod­el­ing ap­proach

2 weeks ago
Pharma
Regulatory

When can RWE trans­late in­to cred­i­ble ev­i­dence? EMA of­fi­cials dis­cuss

2 weeks ago
Regulatory

Trump will pick Stephen Hahn as his next FDA com­mis­sion­er — re­ports

3 weeks ago
People
Regulatory

For­mer FDA chief Califf is set to work full time for Al­pha­bet

3 weeks ago
People
Regulatory

Pa­tient-fo­cused drug de­vel­op­ment: New FDA draft guid­ance delves in­to what’s im­por­tant

3 weeks ago
Regulatory

J&J's em­bat­tled In­vokana gets a boost as FDA ex­pands la­bel

3 weeks ago
Pharma
Regulatory

FDA clears short­er treat­ment reg­i­men for Ab­b­Vie's hep C treat­ment, Mavyret. Will pa­tients ben­e­fit?

3 weeks ago
Pharma
R&D

An­oth­er big bio­phar­ma merg­er runs in­to an­oth­er snag at the FTC. What now?

3 weeks ago
Bioregnum
Deals

OND re­or­ga­ni­za­tion moves for­ward

3 weeks ago
Regulatory

Re­pub­li­cans re­buke Pelosi drug pric­ing bill

3 weeks ago
Pharma
Regulatory

FDA en­dors­es Bavar­i­an Nordic's mon­key­pox vac­cine, mark­ing world's first ap­proval

4 weeks ago
R&D
Regulatory

No­var­tis ac­cus­es 2 AveX­is founders of al­ter­ing da­ta, stonewalling probe — but ex-CSO blasts back

4 weeks ago
Cell/Gene Tx
Pharma

Em­bat­tled AM­AG braces for Oc­to­ber FDA Mak­e­na ad­com, but it need not wor­ry — an­a­lyst

4 weeks ago
R&D
Regulatory

GW Phar­ma's cannabis-de­rived epilep­sy med­i­cine makes the cut in the Eu­ro­pean Union

4 weeks ago
Regulatory

FDA puts the brakes on a rare dis­ease biotech’s PhI­II as reg­u­la­tors wait for an up­date — shares crum­ble

4 weeks ago
R&D
Regulatory
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