Union City, Calif.-based Fibralign announced that it has enrolled the first patient in a European clinical trial evaluating its BioBridge Collagen Matrix as a preventative treatment for secondary ...

Amgen has returned global rights to the investigational immuno-oncology drug, MP0310, ending its licensing agreement with Molecular Partners. The companies entered into the collaboration and licensing ...

SpringWorks unveiled some good news this week with positive topline data supporting its investigational antitumor drug nirogacestat in patients with progressing desmoid tumors.

The FDA’s collaboration with the U.S. Patent Trade Office (USPTO) to bring down barriers that delay generics is off to a good start, according to FDA Commissioner Robert Califf, who points to drug ...

CurvaFix has received FDA’s 510(k) clearance for an updated version of its CurvaFix IM implant for smaller patients with fractures of the pelvis. Based on surgeon feedback, the company redesigned the ...

Spanish drugmaker SOM Biotech has received an Orphan Drug designation from the FDA for SOM3355 (bevantolol hydrochloride), an experimental drug for treating a movement disorder in patients with ...

AstraZeneca is selling off limited rights to its former blockbuster statin drug Crestor to Grünenthal for $320 million upfront and possible future milestone payments of up to $30 million.

The FDA hit Medakit Holdings with a warning letter after finding it sold an unapproved COVID-19 serology test on its website.

A federal court has entered a consent decree against Qualgen — an Oklahoma outsourcing facility that has had multiple, previous run-ins with the FDA — prohibiting the compounder from distributing ...

The FDA has granted a priority review for Purdue’s abbreviated new drug application for nalmefene prefilled syringes for complete or partial reversal of opioid overdose.

Fresenius Medical Care has received 510(k) clearance from the FDA for its VersiPD Cycler, a portable peritoneal dialysis system. The cart-mounted system, which features a large touchscreen and ...

Women with breast or ovarian cancer had fewer hot flashes, less psychiatric distress and better quality of life after using XRHealth’s virtual reality (VR)-artificial intelligence (AI)- based ...