Health Canada has issued a Notice of Compliance (NOC) for AstraZeneca’s HER2-directed antibody drug conjugate (ADC) Enhertu.

The FDA's draft guidance is supposed to cut the cost and time-associated burden of biosimilar development, despite a mixed ...

While Pfizer called the bid “reckless”, Metsera disagrees, stating that it will review the “superior proposal”.

With tighter regulations around biopharma manufacturing and the emergence of advanced therapies, cleanroom design is being ...

Eli Lilly will invest over $1.2bn into its manufacturing site in Puerto Rico, as it aims to assemble a robust supply chain ...

Two of the world’s largest pharmaceutical companies, Pfizer (New York, US) and Roche (Basel, Switzerland), have unveiled more ...

Seres is set to receive up to $3.6m in further non-dilutive funding from the international non-profit partnership, CARB-X.

Dewpoint Therapeutics has received the US FDA's ODD for DPTX3186, a small-molecule condensate modulator for treating gastric ...

MSD has received US Food and Drug Administration (FDA) approval for an updated indication of Winrevair (sotatercept-csrk) for ...

Eli Lilly and NVIDIA will build a new supercomputer to accelerate drug discovery and shorten development cycles.

GSK now owns the global development and commercialisation rights to Empirico's COPD-targeting (siRNA) oligonucleotide, ...

Despite ADX-629 meeting all its endpoints in a Phase II trial, Aldeyra is culling the asset as part of a pipeline ...