The FDA approval of the siRNA drug Redemplo caps off a tumultuous 12 months for Arrowhead, whose partnership with Sarepta caused its own stock to drop during the gene therapy maker’s safety troubles ...

A week into his tenure as head of the FDA’s Center for Drug Evaluation and Research, experts agree that Rick Pazdur is the “ideal fit” to stabilize the agency. And, according to one ex-FDA official, ...

Winrevair yielded significant and meaningful clinical benefits for patients with combined post- and precapillary pulmonary ...

Only one clinical-stage asset from the ProfoundBio acquisition remains in development: The antibody-drug conjugate Rina-S, in ...

Nxera, which formerly went by Sosei, will also reprioritize its pipeline to focus on obesity, metabolic and endocrine ...

With positive data from the Phase III HERIZON-GEA-01 study, Zymeworks and Jazz Pharmaceuticals will file an approval ...

Top Trump administration officials have taken issue with Marty Makary’s management style, pointing to infighting between his ...

The industry’s ability to generate a return on billions of dollars of investment rests on a heavily regulated supply chain ...

BioSpace’s annual Best Places to Work list demonstrates a company’s desirability in the recruitment marketplace. Each organization’s merits are considered with particular emphasis on culture, career ...

Halda Therapeutics is developing oral assets for prostate and lung cancer. The deal comes after Johnson & Johnson set an ...

The companies have yet to disclose how many programs they plan to collaborate on or what indications they will prioritize.

Sarepta must also run a post-marketing study for Elevidys to better assess the risk of serious liver injury in patients dosed ...