Nda

Single tablet treatment on the horizon for pulmonary arterial hypertension

31-May-2023 By Liza Laws

Patients with pulmonary arterial hypertension (PAH) may be able to take a single tablet instead of multiple types if a new drug is approved.

Hutchmed 's rare gastric cancer drug accepted for review in China

20-Apr-2023 By Liza Laws

A drug to treat a rare cancer that grows where the esophagus and stomach join has been accepted for review by the China National Medical Products Administration (NMPA).

Oral film to treat acute migraines to be launched across the US after FDA approval

18-Apr-2023 By Liza Laws

A drug to treat acute migraines has been given approval for a new drug application (NDA) by the US Food and Drug Administration (FDA).

Migraine treatment ‘on track’ for NDA after site qualification

25-Jun-2019 By Maggie Lynch

Zosano completes site qualification batches for its subcutaneous investigational migraine treatment and readies itself for NDA submission by the end of year.

Second CRL given to Acacia after ‘continuing deficiencies’

07-May-2019 By Maggie Lynch

Acacia Pharma receives a second CRL from the US FDA regarding its NDA, after GMP deficiencies during API production were revealed again.