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news.FDA accepts CCP-07 new drug application for full review
This triggers a milestone payment from Vernalis to Tris. The FDA has set a Prescription Drug User Fee Act ("PDUFA") target date for conclusion of its review of
This triggers a milestone payment from Vernalis to Tris. The FDA has set a Prescription Drug User Fee Act ("PDUFA") target date for conclusion of its review of
Myasthenia Gravis caused by antibodies to the muscle-specific kinase (MuSK-MG) is a rare disease that is estimated to inflict 5-8% of all myasthenia gravis patients (equating to an
The Wellbutrin SR brand and generic had US sales of approximately $109.6 million MAT for the most recent twelve months ending in July 2016 according to IMS Health. Dr. Reddy’s
During recent conversations between Dynavax and the FDA, the Agency communicated decisions to enable compliance with the current Prescription Drug User Fee Act (PDUFA) date of December 15,
On 1 July 2016, Aeterna Zentaris signed an exclusive license agreement with affiliates of Orient EuroPharma Co., Ltd for its lead anti-cancer compound, Zoptrex, for the initial indication
The combination of Galenica's Vifor Pharma business unit with Relypsa will create a significant player in cardio-renal care in the US and further strengthen Vifor Pharma's growing international
Arcus raised an additional $70m in equity capital from Taiho Ventures, GV, Invus, DROIA Oncology Ventures and Stanford University, together with its Series A investors, including The Column
The study met its co-primary endpoints and showed a statistically significant and clinically meaningful improvement in overall survival (OS) compared with docetaxel chemotherapy in people with locally advanced
INTEGA, financially backed by Knight Therapeutics (TSX:GUD) and Bloom Burton Healthcare Lending Trust, owns the Canadian distribution rights for a number of well-known and established skin care brands,
This indication is approved under accelerated approval, and continued approval may be contingent upon verification of clinical benefit in subsequent trials. The approval is based on results from