FDA has at least eleven PDUFA dates on its November calendar, 10 of which are for new products. First up is PD-1 x VEGF ...

Gilde’s Impact Council as a multi-stakeholder diligence engine — Former regulators, HTA leaders, payers, clinicians, and ...

For more than a decade, it has been clear that U.S. clinical trials are too slow, too costly, and too far removed from the ...

Only about 5% of rare diseases have an approved therapy, and this is unlikely to change without novel development processes.

The growing trend of co-development, co-commercialization deals may get cut in its prime if the COINS Act is finalized as ...

Two-thirds of China-to-West NewCo deals since 2023 have included a disclosed equity component. Treasury’s proposed ...

Antibody-drug conjugates accounted for more first-in-human studies than any other modality at ESMO 2026, highlighting their ...

STING agonists, drugs that trigger an immune alarm inside cells, have repeatedly failed in clinical trials despite shrinking ...

Gilead is adding to its flegdling oral autoimmune pipeline through a deal with a $1.3 billion upfront payment for a Phase I ...

A proposed U.S. Treasury rule could push China-to-West NewCo deals away from equity-based payments to Chinese licensors, reinforcing some U.S.

One combined protocol can de-risk FDA acceptance of foreign data, capture the U.S. safety and PK evidence regulators want, ...