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 ...

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

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

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

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

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.

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

Sanofi's antibody riliprubart has received orphan drug designation from Japan's MHLW for its potential to treat CIDP.

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

Scientific experts are concerned about what role vaccines will play in US public health strategy under the Trump ...