MHRA renews EAMS scientific opinion for Puldysa in DMD
The drug has been available in the UK through EAMS since June 2017.
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Tag: Marketing Authorisation Application
Santhera submits MAA to EMA for Puldysa
The company is seeking conditional marketing authorisation (CMA) for patients with DMD who are not using glucocorticoids.
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Novo Nordisk files for EU approval of Ozempic in type II diabetes
Patients treated with oral semaglutide demonstrated greater HbA1c reductions and weight loss.
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EMA confirms path for Diurnal’s Chronocort despite trial failure
The company is on track to submit a Marketing Authorisation Application in the fourth quarter of 2019.
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- AI system aims to uncover Alzheimer’s earlier and take on diagnostic delays
- Quell launches chill phase 1/2 trial for novel cartreg therapy
- Bioxytran reports positive phase 1b/2a results for antiviral ProLectin‑M
- FDA approves once‑weekly Sogroya for wider paediatric use
- SolasCure trial shows faster healing with Aurase Wound Gel
