The U.S. Food and Drug Administration’s (FDA’s) evolving guidance on Computer Software Assurance and AI/ML-Based Software ...

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

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

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

Biocon Biologics’ Denosumab biosimilars, Vevzuo and Evfraxy, have received marketing authorisation in the European Union (EU).

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

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

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

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

As the pharma sector braces for sector-specific tariffs from President Trump, what could the impact look like on supply ...

Vetter Pharma, has begun the construction of a new clinical manufacturing facility in Des Plaines, Illinois, US.

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 ...