Capricor Therapeutics is expected to release data from the phase 3 HOPE-3 trial in Q3'25, thus presenting a potential path ...

The trove of more than 200 letters is part of a pledge of transparency from the agency, with the intention to increase public ...

The FDA published a database of letters sent to drugmakers during the review process of medications that provide information on the agency's initial feedback or requirements for more data. These ...

Capricor Therapeutics (NASDAQ:CAPR) shares fell Friday after the company announced it received a complete response letter from the U.S. Food and Drug Administration for its Biologics License ...

The U.S. Food and Drug Administration has published more than 200 complete response letters, or decision letters, sent as ...

The letters, many of which were already available online, detail why the regulators initially declined to approve some drugs.

MISSISSAUGA, ON, June 23, 2025 /CNW/ – Edwards Lifesciences Corporation today announced the company’s EVOQUE tricuspid valve replacement system has received Health Canada’s approval for the ...

Tautges suggested that the board was approving a template for letters stating that a project meets fire flow requirements. Lewis asked Bertram if having the board approve the letter’s formatting would ...

Dear Editor: Environmental justice once again passes Beloit by, this time in the form of the DNR’s latest decision to issue permitting approval allowing Alliant Energy to build out seven "natural gas" ...

Agreement on a new fire protection contract last week means local residents can rest assured they will continue to have high-level safety services into the future. This was a monumental win for our ...