Replimune shares extended their losses, plummeting 56% after the U.S. Food and Drug Administration (FDA) rejected its melanoma drug, RP1. This decision led to a significant market reaction for the biotechnology company.

MacroGenics announced that the U.S. Food and Drug Administration (FDA) has removed a partial clinical hold on its lead development program.

Dianthus's stock rose after the U.S. Food and Drug Administration (FDA) agreed to proposed changes for the company's lead program.

FDA Unveils New Platform For Tracking Side Effects Authored by Zachary Stieber via The Epoch Times (emphasis ours), The Food and Drug Administration on March 11 made public a new, consolidated platform for tracking side effects experienced by people following receipt of vaccines and drugs. The U.S. Food and Drug Administration (FDA) in White Oak, Md., on June 5, 2023. Madalina Vasiliu/The Epoch Times Officials are folding a number of existing platforms into the Adverse Event M...

A key US Senator has launched an investigation into the Food and Drug Administration (FDA) regarding its denials of drugs for rare diseases.

A Wall Street Journal opinion piece raises questions about the leadership and decision-making authority within the Food and Drug Administration (FDA).

Telix Pharmaceuticals saw its stock increase after its imaging agent for brain cancer received a review designation from the U.S. Food and Drug Administration (FDA).

The U.S. Food and Drug Administration (FDA) has stated that Amgen's drug Tavneos has been linked to cases of liver injuries and deaths, as reported by the Wall Street Journal.

Sanofi has announced that its drug Venglustat has been granted Breakthrough Therapy Designation by the U.S. Food and Drug Administration (FDA).

Inovio Pharmaceuticals Inc. (NASDAQ: INO) announced that it has submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for its investigational DNA medicine INO-3107 for the treatment of recurrent respiratory papillomatosis (RRP).

The U.S. Food and Drug Administration (FDA) is reportedly planning to ease testing requirements for biosimilar drugs, a move aimed at making it easier and faster to bring these less expensive alternatives to market.

The Philippine Food and Drug Administration (FDA) has placed major retail chains Landers Superstore and S&R Membership Shopping under scrutiny after inspections revealed unregistered and improperly labeled products.

Boston Scientific has announced that its Asurys Fluid Management System has received clearance from the U.S. Food and Drug Administration (FDA).

The U.S. Food and Drug Administration (FDA) has confirmed that Amgen's drug Tavneos is linked to cases of liver injuries and deaths, as reported by the Wall Street Journal.

The U.S. Food and Drug Administration (FDA) has granted approval for Denali Therapeutics' new therapy designed to treat a genetic disorder in children.

MANILA, Philippines—The Food and Drug Administration (FDA) on Wednesday said the controlled destruction of infant formula products, earlier recalled by Nestlé Philippines, began this week, marking…

The U.S. Food and Drug Administration (FDA) plans to offer bonus payments to its staffers who successfully complete speedy drug reviews, aiming to accelerate the approval process for new medications.

FDA Dropping Requirement For 2 Studies For New Drug Approvals Authored by Zachary Stieber via The Epoch Times (emphasis ours), The Food and Drug Administration (FDA) will approve many new drugs based on one trial moving forward, agency leaders have said. FDA Commissioner Dr. Marty Makary in Washington on July 29, 2025. Saul Loeb/AFP via Getty Images The FDA has typically required two studies from companies seeking approval for most new drugs, although in recent years it has ap...