Seres Therapeutics, the biotech company that pioneered one of the first microbiome drugs, a pill containing bacterial spores ...

Back in 2019, as part of a program focused on improving documentation and communications for drug approvals, the FDA made a ...

Avadel Pharmaceuticals is still waiting on an answer from the FDA on whether its once-nightly narcolepsy drug Lumryz will be ...

Welcome to Endpoints News’ manufacturing briefs, where we bring you essential news on new builds, collaborations, recalls and ...

Eli Lilly is rapidly increasing its presence in Ireland with a $1 billion expansion to bolster its biologic drug production ...

To in­crease the pace of rare dis­ease drug ap­provals, the FDA should em­brace non­tra­di­tion­al da­ta, de­ploy new forms ...

Manchester, UK-based F2G has patched together another $100 million in funding a little over a year after receiving a CRL for ...

While it’s put more em­pha­sis on be­com­ing an “im­munol­o­gy pow­er­house” in re­cent quar­ters, Sanofi still shows signs ...

The FDA has approved Johnson & Johnson’s IL-23 blocker Tremfya to treat ulcerative colitis, a boost to the pharma’s hopes ...

In what's shaping up to be another slow year for biotech IPOs — better, however, than the 2022 and 2023 doldrums — Jim Healy is somewhat of an outlier. Only four biotechs from this year's IPO class ...

Debiopharm and ITM announced a licensing deal for a ​​radiopharmaceutical treatment that’s being investigated in several cancers. Debiopharm, which is based in Switzerland, is eligible for upfront, ...

Charles River Laboratories is cutting around 3% of its total workforce in “response to current trends,” a company spokesperson told Endpoints News in an email. The Wilmington, MA-based company is ...