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 (CAPR) shares fell Friday after the company announced it received a complete response letter from the FDA for its Biologics License Application for Deramiocel.

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

The FDA has published more than 200 complete response letters, sent as replies for applications submitted from 2020 to 2024.

As the controversial powerline fight continues, the developers have begun sending out letters to residents about surveys starting, however the letter raises mor ...

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

Obesity is associated with financial hardship and food insecurity, according to a research letter published online June 24 in ...

RHOBH alum Yolanda Hadid opens up about the special person in her life amid her many life and relationship changes. Read on for details.

The Board of Supervisors voted to send the Department of Homeland Security a letter clarifying that Tehama County is not a sanctuary jurisdiction.

Opinion Letters to the Editor Letters: Will a prison-bound Michael Madigan send a message to those in positions of trust?

Emerging and fugitive contaminants (EFCs) can be introduced into the food chain through plants, particularly crop plants, and have threatened food safety and human health. The method for determination ...

Letter Fire initially started 10:04 p.m. June 8 in Plumas County. Since its discovery eight days ago, it has burned 11.1 acres. The fire crew managed to contain the fire entirely as of Monday ...