The FDA approval was based on the pooled data from two pivotal studies: the EMERALD trial and NI-0501-06.

Ogsiveo (nirogacestat) is approved by the Food and Drug Administration (FDA) for adults with progressing desmoid tumours requiring systemic treatment. The European Medicines Agency’s (EMA) Committee ...

German contract development and manufacturing organisation Vetter Pharma has commenced construction of a new $285m clinical manufacturing facility in Des Plaines in the US state of Illinois with a ...

Modella AI has signed a multi-year agreement with AstraZeneca for expediting AI-driven oncology clinical development.

Proposals for drug exclusivities and feeble measures to combat drug shortages are unlikely to boost innovation, say some ...

A new podcast from industry experts MarketScan explains why social determinants of health are critical to patient care.

The approval comes amid speculation that AstraZeneca CEO Pascal Soriot is considering delisting its UK stock market listing for the US.

Brii Biosciences and Joincare Pharmaceutical have signed a licence and technology transfer agreement for BRII-693 for MDR/XDR infections.

The FDA has approved Takeda’s new immunoglobulin therapy, Gammagard liquid ERC [immune globulin infusion (human)], to treat ...

Via its affiliate CB Biotechnology, US-headquartered Future Pak will purchase shares in Theratechnologies for $3.01 each plus a contingent value right (CVR) of $1.19 on the achievement of future ...

Lynozyfic has the potential to be administered monthly, giving it an advantage over J&J and Pfizer’s marketed products.

Torrent has signed definitive agreements to acquire stake in JB Pharma at an equity valuation of Rs256.89bn ($3bn) on a fully ...