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

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

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

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 ...

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

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

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 ...

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 ...

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 ...

The additional cuts, which will primarily occur between 2027 and 2029, will cost some $6 billion as the pharma tries to ride out a post-COVID headache while facing stiff patent headwinds for major ...

If AstraZeneca and Bristol Myers Squibb were to successfully become one company, analysts say it could reset the current deal environment, which has picked up greatly in the first half of the year.