While both drugmakers face looming patent cliffs, analysts say joining forces could help Bristol Myers Squibb replenish its ...

In briefing documents published Monday ahead of an advisory committee meeting for deramiocel, the FDA disagreed with Capricor ...

The FDA's rebuff of Replimune comes a day after the agency similarly called into question the Phase 3 trial for Capricor’s ...

With so many unknowns, Biogen is carefully eyeing its next-gen Alzheimer’s treatment diranersen as a high-risk, high-reward ...

When signing a biotech licensing deal in China, experts say that pharma’s patent attorneys need to understand the ...

As biologics, biosimilars and GLP-1s drive demand for sterile drug products, CMOs and CDMOs are investing in fill-finish, lyophilization, inspection and packaging capacity to keep pace with a dynamic ...

Recent advances in ADC development have led to increasing diversity in antibody, linker and payload design. Successful drug ...

UniQure is ready to put its Huntington’s disease gene therapy through an advisory committee meeting—even as the broader rare disease space has been put on edge by recent FDA scrutiny of assets by ...

Foundayo clocked $98 million in sales in Q2, the first quarter it was available, compared to Novo’s $355 million for the same sales period. After entering the obesity market and soundly stealing ...

A legal dispute between the FDA and Eli Lilly over whether the highly anticipated obesity candidate retatrutide is indeed a biologic has come to a head as the company prepares to submit the medicine ...

The FDA has been trying to mend fences with rare disease drug developers and patient groups since the departure of former Commissioner Marty Makary three months ago. But advisory committee meetings ...

Seven months after launching with $16 million in seed financing, Jennifer Doudna’s Aurora Therapeutics is pivoting away from its lead indication, phenylketonuria, owing to growing competition in the ...