Company Anticipates Submitting for U.S. Accelerated Approval in H1 2026 - WALTHAM, Mass., Jan. 21, 2025 (GLOBE NEWSWIRE) -- Dyne Therapeutics, Inc. (Nasdaq: DYN), a clinical-stage neuromuscular diseas ...

The challenge is that unlike clinical outcomes and drug tolerability ... chart review studies, there are some exceptions. The need for informed consent can prolong study timelines as well as ...

Donald Trump, who overcame impeachments, indictments and assassination attempts, will be sworn in Monday as the 47th U.S. president. Watch the events and get updates throughout the day.

As seen with the resolution of FY 2024 appropriations in March 2024, the compressed timeline for FY 2025 appropriations ... development by agencies, or under review by the Office of Management ...

Donald Trump, who overcame impeachments, indictments and assassination attempts, was sworn in Monday as the 47th U.S.

The U.S. State Department, Bureau of Consular Affairs offers a chart defining different types of visas ... the USCIS released an interim Final Rule informing the Department of Labor to review the ...

The FDA granted priority review for belzutifan for treating advanced pheochromocytoma and paraganglioma, with a PDUFA date set for May 26, 2025.

Merck (MRK) announced the U.S. FDA has accepted for priority review a supplemental new drug application seeking approval of Welireg, Merck’s ...

Merck & Co. has won U.S. Food and Drug Administration priority review for its application seeking expanded use of its Welireg oral cancer drug in patients with rare tumors that form in and around the ...

The regulatory agency will review MSD’s new drug application (NDA) for Welireg under a Priority Review, with a Prescription Drug User Fee Act (PDUFA) target action date of 26 May 2025.

A Prescription Drug User Fee Act target date of May 27, 2025 has been assigned to the application. The Food and Drug Administration (FDA) has accepted for Priority Review the New Drug Application ...

Priority review for Welireg is based on data from the Phase II LITESPARK-015 trial, which showed promising response rates in patients with advanced, unresectable, or metastatic pheochromocytoma and ...