Spravato gets FDA Advisory Committee approval
FDA advisory committees have jointly voted in favour of approving Janssen’s Spravato nasal spray CIII for adults living with treatment-resistant depression.
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Tag: NDA
Shield files Feraccru with the FDA
The UK’s Shield Therapeutics has successfully submitted an application to market iron deficiency therapy Feraccru in the US.
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Acacia’s PONV drug under US review
US regulators have accepted for review Cambridge, UK-based Acacia Pharma’s application for post-operative nausea and vomiting (PONV) drug Baremsis.
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- Kahimmune Therapeutics enters licensing agreement with Gustave Roussy and SATT Paris-Saclay
- IBSA UK&I launches Perovial for the treatment of acute Peyronie’s disease
- En Carta Diagnostics’ EC Pocket Lyme test receives FDA Breakthrough Device Designation
- ALK’s EURneffy receives positive CHMP opinion for emergency anaphylaxis treatment in children
- CERo reports encouraging early data from phase 1 trial of CER‑1236
