FDA grants priority review to Pfizer and Astellas’ sNDA for XTANDI
The regulator has provided a prescription drug user fee act (PDUFA) date of fourth quarter this year for the review. The sNDA is being reviewed under two initiatives
The regulator has provided a prescription drug user fee act (PDUFA) date of fourth quarter this year for the review. The sNDA is being reviewed under two initiatives
These therapies include an immunomodulatory agent, a proteasome inhibitor, and an anti-CD38 antibody. Talvey recently received the US Food and Drug Administration’s approval for the same indication in
MAb-AR20.5 is an IgG1k type murine monoclonal antibody that attaches specifically to the circulating and tumour-associated antigen (MUC1) expressed on pancreatic cancer cells. It is said to become
The regulator has provided the Prescription Drug User Fee Act (PDUFA) date of 20 December this year for the review. Currently approved under accelerated approval, TARPEYO is developed
The Series B round was co-led by Redmile Group and Bain Capital Life Sciences. It saw participation of new and existing investors including RA Capital Management, Samsara BioCapital,
As per the terms of the deal, Sprint will receive $3m as upfront payment. Day One will also reimburse Sprint for pre-clinical research and development expenses. Additionally, Sprint
The regulatory agency has granted priority review for this NDA with Prescription Drug User Fee Act (PDUFA) target action date of 22 February next year. It earlier granted
Lilly signed the definitive agreement to acquire Versanis Bio in July this year. At the time of the deal announcement, its terms specified that shareholders of Versanis were
Stockholders of Chinook will receive $40.00 in cash per share, a total of $3.2bn, from Novartis. Upon achieving certain regulatory milestones, they will further receive $4.00 in cash
In June this year, the therapy, in combination with Genentech’s Tecentriq received FDA fast track designation (FTD) for the treatment of extensive-stage small cell lung cancer (ES-SCLC) patients.