Genentech Inc. won regulatory approval Tuesday to market an eye implant that can be refilled every six months with an already ...

Lately, one of America's leading pharmaceutical companies can't catch a break from Wall Street. Shares of Vertex ...

Going forward, we may see more instances in which insurers deny or (temporarily) severely restrict coverage of accelerated ...

Amid the uproar over the firing of 18 inspectors general, a report offering a coda to the aducanumab approval episode has ...

Supernus Pharmaceuticals' FDA approval for ONAPGO in Parkinson's Disease offers optimism despite past challenges, with a ...

Securing FDA clearance or approval is a major accomplishment for medical device and pharmaceutical companies, but it’s not ...

The FDA has granted orphan drug designation (ODD) and RPDD to Arbor Biotechnologies' ABO-101, to treat primary hyperoxaluria ...

The proposed guidance aims to provide a framework for the approval of personalised mRNA-based cancer vaccines.

The U.K. is continuing to shape up regulation, adding reform of its accelerated drug approval process and its draft guidance on personalized mRNA cancer vaccines to new clinical trial regulations that ...

Trump's pick for HHS secretary who endured confirmation hearings last week—has repeatedly criticized industry ties to the FDA ...

APAC offers stability in an increasing challenging global geopolitical environment for clinical stage drug development.

EBR Systems is super confident the US medical gatekeeper will approve Wise, the world's first wireless pacemaker device.