Praxis Precision Medicines Wins FDA Breakthrough Status for Elsunersen in Rare Epilepsy
Phase 2 data showed 77% seizure reduction and sustained benefits up to 1 year.
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EB613 Set to Become First Once-Daily Oral Tablet for Osteoporosis as Entera Bio Advances to Phase 3
Entera Bio receives positive FDA feedback on its pivotal Phase 3 trial design for EB613, the potential first once-daily oral tablet to stimulate bone formation in postmenopausal women with osteoporosis.
No Efficacy or Safety Issues: Achieve Life Sciences Gets FDA CRL for Cytisinicline
Achieve Life Sciences received an FDA Complete Response Letter for its cytisinicline NDA due to manufacturing issues at a former facility. No efficacy or safety deficiencies were identified.
Breakthrough LSD-Derived Drug DT120 Shows Dramatic Antidepressant Effect in Phase 3 Trial
Definium’s DT120 pill showed strong fast and lasting depression relief in Phase 3, with good safety and big symptom cuts.
FDA Aligns with REGENXBIO on Accelerated Approval Pathway for NAVSUNLI Gene Therapy in Hunter Syndrome
FDA reverses course and agrees to review existing data for NAVSUNLI gene therapy in Hunter syndrome.
AbbVie Bolsters Immunology Pipeline with $10.9 Billion Apogee Acquisition
The acquisition would add a longer-acting alternative to Dupixent for inflammatory diseases.