DiagnaMed Granted FDA Orphan Drug Designation for Molecular Hydrogen to Treat Amyotrophic Lateral Sclerosis
"Receiving orphan drug designation from the FDA is a significant milestone for DiagnaMed and validates the promise of molecular hydrogen as a potential treatment for ALS. We are excited to partner ...
NeuroSense’s ALS drug PrimeC shows success in phase 2b, eyes final trial
PrimeC has been given an ‘Orphan Drug’ status by the FDA (Food and Drug Administration) and EMA (European Medicines Agency).
Business Wire5h
Protagonist and Takeda Announce Positive Topline Results from Phase 3 VERIFY Study of Rusfertide in Patients with Polycythemia Vera
Protagonist Therapeutics, Inc. (“Protagonist”) (NASDAQ:PTGX) and Takeda (TSE:4502/NYSE:TAK) today announced positive topline results for the Phase 3 V ...
FierceBiotech7d
5 Market Access Mistakes That Can Derail Your EU Orphan Drug Launch
| Avoid common pitfalls in EU orphan drug market access—learn how local expertise can help navigate pricing, reimbursement, ...
Revive Therapeutics Announces LOI to Acquire DiagnaMed’s Molecular Hydrogen Program
TORONTO, March 3, 2025 – Revive Therapeutics Ltd. (“Revive” or the “Company”) (OTCQB: RVVTF) (CSE: RVV) (FRANKFURT:31R), a specialty life sciences company focused on the research and development of ...
Cure Today21h
First Patient With Small Cell Lung Cancer Dosed With Peluntamig
The first patient with small cell lung cancer has been dosed in a trial of peluntamig (PT217) combined with chemotherapy.
labiotech3d
Rare Disease Day: seven drugs awaiting approval in 2025
As we observe Rare Disease Day today, let us take a look at seven drugs poised to be approved to address rare diseases in ...
Faron Pharmaceuticals Oy: Inside Information: FDA Grants Orphan Drug Designation for Bexmarilimab in MDS
Faron Pharmaceuticals Ltd | Company announcement | March 03, 2025 at 14:00:00 EET Inside Information: FDA Grants Orphan Drug Designation for Bexmarilimab in MDS Key highlightsOrphan Drug Designation f ...