FDA Priority Review granted for GSK’s Zejula
There are around 7,500 new ovarian cancer cases in the UK every year.
Read More
Tag: New Drug Application
J&J submits sNDA for Invokana after premature end to clinical trial
If approved, the drug will be the only therapy in nearly 20 years to reduce the risk of end-stage kidney disease.
Read More
Biogen & Alkermes get NDA for MS drug
The FDA has accepted the New Drug Application (NDA) for Biogen & Alkermes’ Diroximel Fumarate in multiple sclerosis (MS).
Read More
- FDA approves new high dose Spinraza regimen for SMA
- Viridian reports positive results from elegrobart phase 3 trial
- Cure Parkinson’s convenes expert panel to assess £2 million combination therapy funding call
- Kygevvi approved in Europe as first treatment for TK2d
- Tozorakimab shows significant benefit in two major COPD trials
