Two weeks into his tenure leading the FDA’s biologics center, Vinay Prasad has made his mark with a new framework for ...

The FDA's Oncologic Drugs Advisory Committee voted 8 to 1 against whether Genentech's pivotal trial is applicable to the US ...

The gene editing company CRISPR Therapeutics surprisingly struck a deal with China-based biotech Sirius Therapeutics to ...

FDA chief Marty Makary and new CBER Director Vinay Prasad said that future Covid-19 vaccine approvals will focus on adults ...

Under the program that was first announced by President Trump last week, the US would target prices based on benchmarks from ...

Biotech execs express concerns over FDA changes, NIH cuts, and Trump's tariffs. Industry confidence low amid poor funding ...

Pfizer is dishing out $1.25 billion upfront and up to $4.8 billion in milestone payments to Shenyang-based 3SBio for the ...

A longevity startup called Retro Biosciences is working on personalized blood disorder therapies thanks to a partnership with ...

Regeneron has a long history with its gene-sequencing efforts, which likely provides some hints as to why the biotech saw the ...

Boehringer Ingelheim claimed two Phase 3 wins for its PDE4 inhibitor in fibrotic lung diseases, but some Wall Street analysts said the candidate’s “modest” efficacy and limited combination potential ...

Regeneron is acquiring 23andMe through a court-supervised sale, following 23andMe's bankruptcy filing and recent struggles.

CellCentric raises $120M Series C for p300/CBP inhibitor inobrodib in multiple myeloma, plans Phase 2/3 trial for accelerated ...