The FDA's rebuff of Replimune comes a day after the agency similarly called into question the Phase 3 trial for Capricor’s ...
In briefing documents published Monday ahead of an advisory committee meeting for deramiocel, the FDA disagreed with Capricor ...
When signing a biotech licensing deal in China, experts say that pharma’s patent attorneys need to understand the ...
With so many unknowns, Biogen is carefully eyeing its next-gen Alzheimer’s treatment diranersen as a high-risk, high-reward ...
Axiom Biosciences is thinking outside of the box, betting on a public debut in Hong Kong to raise capital and grow into a ...
Novartis will continue to be on the lookout for bolt-on deals below $2 billion, CEO Vas Narasimhan said Tuesday on the pharma ...
Eighteen companies have gone public this year so far, putting 2026 on pace to record the highest number of IPOs since the ...
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 ...
Recent advances in ADC development have led to increasing diversity in antibody, linker and payload design. Successful drug ...
The FDA’s Cellular, Tissue and Gene Therapies advisory committee voted 10 to 3 in favor of Replimune’s immunotherapy for advanced melanoma in combination with Bristol Myers Squibb’s Opdivo, but trial ...
After an FDA advisory committee voted 9-3 on Wednesday against recommending Capricor Therapeutics’ Duchenne muscular dystrophy cardiomyopathy drug for approval, stakeholders allege an “ulterior motive ...
The investment will expand Resilience’s U.S. capacity to make the KwikPen device Eli Lilly uses to deliver its injectable diabetes and obesity medicines. Eli Lilly is expanding its partnership with ...
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