Replimune Seeks Third FDA Approval Attempt After Executive Departure
Replimune is pursuing a third attempt at FDA approval following the departure of Makary.
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Replimune is pursuing a third attempt at FDA approval following the departure of Makary.

The US Food and Drug Administration (FDA) is experiencing significant leadership turmoil, with a top drug regulator departing and claiming she was fired. This departure is part of a broader shakeup within the agency's drug and biologics divisions.
Replimune's stock surged following the resignation of FDA Commissioner Makary. Separately, Alibaba's stock also saw a significant increase after the release of its latest earnings report.

A former private prison official has been appointed as the new acting director for U.S. Immigration and Customs Enforcement (ICE). This appointment has drawn attention due to his previous experience in the private prison sector.
Former President Trump has suggested relocating American troops from Germany to Poland, a proposal that Warsaw has indicated it would welcome. This potential move has led to concerns among NATO allies regarding a possible broader reduction of US military presence in Europe.
The head of the Food and Drug Administration (FDA), Dr. Makary, has defended the agency's decisions to reject certain drug applications, following recent criticism.
An article from the Wall Street Journal delves into what is being termed 'President Trump’s Marty Makary Problem', suggesting a specific issue or challenge involving the two figures.

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...

A report by the Brownstone Institute alleges that the US Food and Drug Administration (FDA) has covered up child deaths linked to Covid vaccines, citing former FDA Commissioner Dr. Marty Makary.

Dr. Marty Makary resigned as FDA commissioner on Tuesday, with a White House official confirming that his resignation was submitted via text message. This event has sparked discussion about the appropriateness of resigning through text.

Dr. Marty Makary's resignation from his position at the Food and Drug Administration is reportedly widening an existing leadership gap within the U.S. Department of Health and Human Services. This departure adds to ongoing concerns about leadership stability.
The departure of Makary from the FDA has given the biotech industry hope that a period of perceived 'circus' or instability at the agency is now over.

The Trump administration has appealed a US court decision that deemed its 10% tariff measures illegal, adding to economic uncertainty. This comes amidst other developments including a planned firing of the FDA head and monitoring of Hantavirus cases.

U.S. Food and Drug Administration Commissioner Marty Makary has defended the agency's drug approval decisions in an interview, following a wave of backlash.

A mother of a son with Duchenne muscular dystrophy is urging FDA Commissioner Makary to prioritize and accelerate the approval process for treatments for rare diseases, citing the impact of delays on families.

FDA chief Marty Makary addresses the contentious period for the agency, marked by significant staff and budget cuts, and discusses changes to vaccine policy and the use of compounded GLP-1s.

A second high-ranking FDA official has departed the organization in less than a week, with acting drug chief Dr. Tracy Beth Høeg claiming she was fired. This follows the resignation of Commissioner Makary.
An article discusses the need for a reset at the FDA, suggesting that the successor to Marty Makary should learn from his previous mistakes.

Marty Makary, the head of the Food and Drug Administration (FDA), has resigned from his position under pressure, having faced criticism from both sides of the political aisle.

Donald Trump is preparing for a significant summit with Chinese President Xi Jinping, where trade, Taiwan, and rare metals are expected to be key topics. This comes as his administration faces scrutiny over its stance on Iran and potential troop withdrawals from Germany.

Operation Stork Speed, part of the Trump administration's "Babies First" approach, seeks to enhance the safety, availability, and quality of infant formula, addressing parental concerns.
A report describes an environment of paranoia, turmoil, and backlash within the Food and Drug Administration (FDA) during the tenure of Marty Makary.
The Wall Street Journal published an opinion piece titled "Dr. Makary and Mr. Hyde at the FDA," offering commentary on the Food and Drug Administration.

The U.S. Food and Drug Administration has reversed its earlier decision and will now review Moderna's application for its modified influenza vaccine.