FDA+ channel feed – Endpoints News

FDA+ channel feed

Beam's base-edited allogeneic CAR-T gets FDA go-ahead after four-month wait

3 years ago

FDA rejects Y-mAbs’ neuroblastoma drug after taking issue with clinical trial design

3 years ago

Rigel Pharma scores FDA approval for leukemia, kicking off showdown with Servier in IDH1

3 years ago

Updated: FDA remains silent on orphan drug exclusivity after last year's court loss

3 years ago

FDA approves Rebyota, Ferring's poop-based drug to fight C. diff infection

3 years ago

Argenx purchases $100M+ FDA priority review voucher from bluebird bio

3 years ago

Lexicon slams FDA over hearing denial following a CRL for its SGLT2 inhibitor candidate

3 years ago

UK regulator warns of severe eye reactions following use of Sanofi and Regeneron's Dupixent

3 years ago

Viatris withdraws accelerated approval for topical antimicrobial 24 years later

3 years ago

FDA rejects Crinetics' current PhII design for hyperinsulinism drug

3 years ago

Updated: Roche pulls PD-L1 blockbuster's accelerated approval in bladder cancer

3 years ago

Industry groups, CVS pick apart FDA's proposed pathway for generics to carve out OTC indications

3 years ago

Fourth accelerated approval in Duchenne? Sarepta gets priority review for gene therapy amid FDA scrutiny

3 years ago

Spectrum implodes after a harsh public slapdown and now a CRL from Richard Pazdur

3 years ago

Suspended California cell therapy manufacturing site hit with FDA warning letter over major quality concerns

3 years ago

FDA preps for DMD drug generics as Sarepta has yet to finish its confirmatory trial

3 years ago

CSL lands FDA approval for hemophilia B gene therapy, sets $3.5M list price

3 years ago

The accelerated approval pathway is evolving in plain sight, with or without congressional help

3 years ago

Days after reporting PhIII failure, GSK pulls BCMA drug from US market — but it's not giving up entirely yet

3 years ago

Anti-abortion groups file suit against FDA in Texas, demands agency revoke approval for abortion pill

3 years ago

FDA hits Iovance with one more delay for TIL therapy, extending BLA filing until 2023

3 years ago

Updated: Provention prices drug to delay type I diabetes at $193K as FDA nod kicks off US launch with Sanofi

3 years ago

Takeda touts positive first-line leukemia results — but isn't quite ready to reveal the hard data

3 years ago

Lilly wins FDA approval for second interchangeable insulin biosimilar

3 years ago

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