Regulatory channel feed

FDA lifts hold on Abeon­a's but­ter­fly dis­ease ther­a­py, paving way for piv­otal study

1 hour ago
R&D
Regulatory

While No­var­tis com­bats gener­ic on­slaught in the courts, FDA ap­proves first Gilenya copy­cats

3 days ago
Pharma
Regulatory

The fu­ture of Ipsen’s new $1.3B drug is in doubt as safe­ty fears force the FDA to slam the brakes on late-stage ...

3 days ago
R&D
Regulatory

Sen­ate com­mit­tee backs Stephen Hahn as the next FDA com­mis­sion­er

6 days ago
People
Regulatory

FDA fi­nal­izes guid­ance on adap­tive tri­al de­signs

6 days ago
Regulatory

FDA to Lex­i­con: Yeah, that's still gonna be a no from us

6 days ago
Regulatory

FDA ap­proves 5 new cost­ly drugs well ahead of PDU­FA dates

Last week
Pharma
Regulatory

Make that 2 new sick­le cell dis­ease block­buster hope­fuls OK’d by the FDA in just a few days

Last week
R&D
Regulatory

Roche, PTC will now get an FDA de­ci­sion on their SMA drug in 6 months — fac­ing off with Bio­gen, No­var­tis

2 weeks ago
R&D
Regulatory

Aque­s­tive nabs FDA OK for oral film ver­sion of gener­ic ALS drug

2 weeks ago
Pharma
Regulatory

FDA re­leas­es 81 prod­uct-spe­cif­ic guid­ances

3 weeks ago
Pharma
Regulatory

New epilep­sy com­pa­ny on the block wins FDA ap­proval for made-in-Ko­rea drug to treat fo­cal seizures

3 weeks ago
R&D
Regulatory

Five drugs, in­clud­ing two No­var­tis ther­a­pies, win EMA en­dorse­ment

4 weeks ago
R&D
Regulatory

EMA fi­nal­izes clin­i­cal de­vel­op­ment guide­line for new gout treat­ments

4 weeks ago
Regulatory

In a first, FDA green-lights use of a Chi­nese built can­cer ther­a­py — and more are com­ing

4 weeks ago
China
Regulatory

Amarin emerges from an ex­pert pan­el re­view with a clear en­dorse­ment for Vas­cepa and high odds of suc­cess when the FDA ...

4 weeks ago
Regulatory

Ahead of FDA de­ci­sion on BTK drug, Am­gen-part­nered BeiGene is one step clos­er to Chi­na OK for PD-1

4 weeks ago
China
Regulatory

FDA to re­voke or­phan des­ig­na­tion for opi­oid ad­dic­tion drug Sublo­cade

4 weeks ago
Pharma
Regulatory

De­cry­ing 'ar­bi­trary and capri­cious' ac­tion, Re­genxBio sues FDA over clin­i­cal holds on gene ther­a­py

4 weeks ago
Cell/Gene Tx
Regulatory

HHS is tak­ing Gilead to court, seek­ing dam­ages for in­fring­ing gov­ern­ment HIV patents

Last month
Pharma
Regulatory

Re­genxBio runs in­to par­tial hold for an­ti-VEGF gene ther­a­py as FDA in­ves­ti­gates de­liv­ery de­vice

Last month
Cell/Gene Tx
Regulatory

FDA re­names and re­struc­tures on­col­o­gy of­fice

Last month
Regulatory

Is FDA do­ing enough to bring biosim­i­lars to mar­ket? Ex­perts dis­cuss

Last month
Pharma
Regulatory

Make room for poop trans­plants, even if a stool-based ther­a­py is even­tu­al­ly ap­proved — in­sist doc­tors and pa­tients ...

Last month
Regulatory
1234 Next page Last page