Regulatory
The WHO reports it’s too early to tell if the monkeypox outbreak could become a pandemic, but believe there is a window of opportunity to control the cases.
The FDA has decided to extend the Prescription Drug User Fee Act (PDUFA) review date for TG Therapeutics’s ublituximab until December 2022.
On June 5, the FDA is expected to decide the fate of Acer Therapeutics’ experimental treatment for Urea Cycle Disorders (UCDs), ACER-001. CEO Chris Schelling spoke with BioSpace.
Antios Therapeutics received a clinical hold on its Hepatitis B virus (HBV) combinatorial therapy from the U.S. Food and Drug Administration on Wednesday.
Vanda has again taken legal action against the FDA over its supposed failure to grant tradipant Fast Track designation. In its complaint, Vanda is challenging the FDA’s decision to deny the designation.
If approved, etranacogene dezaparvovec would be the first gene therapy treatment for hemophilia B.
The American Society of Clinical Oncology and the Association of Community Cancer Centers are combining their efforts to increase racial and ethnic diversity in clinical trials.
Based on topline data, Pfizer stated that three doses of the COVID-19 vaccine met all immunobridging criteria required for EUA. The FDA’s advisory committee will meet June 15 to discuss the matter.
Sunday night, U.S. health authorities announced that they may have found the third documented case of monkeypox in a patient in South Florida.
Alnylam Pharmaceuticals shared 18-month results from its phase III Helios-A clinical study demonstrating that vutrisiran improves clinical cardiac symptoms in patients with hATTR.
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