PDUFA for NDA – First Review 26 September
10 Approvals To Watch Out For In Q3
After a quiet July, August and September are shaping up to be busy on the approvals front. Already this month, the US FDA has approved Adaptimmune’s Teclera for synovial sarcoma, Phathom’s Voquezna for gastro-esophageal reflux disease and Servier’s Voranigo for gliomas. Here, Scrip takes a look at ten other approvals for novel products in the offing for the third quarter.
More from New Products
Pipeline Watch is a weekly snapshot of selected late-stage clinical trial events and approvals announced by pharmaceutical and biotech companies at medical and industry conferences, in financial and company presentations, and in company releases and statements.
• By
The small interference RNA therapeutic can be used by patients regardless of inhibitor status.
• By
The company is planning to launch oxylanthanum carbonate for chronic kidney disease patients on dialysis with hyperphosphatemia.
• By
After a long wait for patients, Vykat has become the first drug approved for Prader-Willi syndrome symptoms, opening the market up for Soleno and future challengers.
More from Scrip
• By
Pharma executives and investors are waiting with bated breath to find out if President Trump will include drugs in a new round of tariffs to be announced on 2 April.
• By
After failing a Phase II monotherapy study in early Parkinson’s, Cerevance will focus on adjunctive therapy without abandoning the monotherapy concept.
• By
The firm has lofty ambitions for the aldosterone synthase inhibitor to treat hypertension and kidney disease.