United Therapeutics has linked a once-daily drug candidate to a 55% drop in the risk of clinical worsening in a phase 3 trial ...

By using a mobile app and patient portal called MyQuest, “adult users can prompt the tool to define test names and medical ...

The FDA has liberated the second of two Intellia Therapeutics clinical trials that were put on hold last October following a report of serious liver toxicity that later led to death.

Shares of uniQure plummeted more than 40% in premarket trading Monday after the company confirmed the FDA has rejected its current data package for AMT-130, a highly anticipated gene therapy for ...

BioAtla is laying off 70% of its workforce as the antibody biotech mulls whether to sell off its remaining assets. | BioAtla is laying off 70% of its workforce as the antibody biotech mulls whether to ...

Lynk Pharmaceuticals has reported another phase 3 win in China for its next-gen JAK inhibitor, this time hitting skin clearance goals among patients with eczema. | Lynk Pharmaceuticals has reported ...

The Swiss drugmaker reported a phase 3 win for fenebrutinib over Sanofi's Aubagio in RMS in November. In that study, Roche linked its drug candidate to a 59% reduction in the annualized relapse rate ...

Aardvark Therapeutics has seen its share price halve in value after the company paused a phase 3 study of its lead metabolic asset over heart-related data.

A panel of physicians, biotech leaders and patient advocates took aim at the FDA during a Senate hearing Thursday on how the ...

BioNTech and partner DualityBio are accelerating the development of their B7-H3 antibody-drug conjugate into a phase 3 trial for metastatic castration-resistant prostate cancer (mCRPC). | BioNTech and ...

Asahi Kasei has unveiled plans to acquire Aicuris in a deal worth 780 million euros ($920 million), marking the latest in a ...

The FDA slammed ExThera with a warning letter for deviating from the regulatory agency’s guidelines by promoting and selling ...