Marty Makary

Regenxbio announced it will submit its Duchenne muscular dystrophy gene therapy for accelerated approval, despite the FDA previously requesting an additional trial. The FDA appears to be reversing recent rejections of gene therapies, including a Hunter syndrome treatment reconsidered after key officials, Marty Makary and Vinay Prasad, left the agency.

Federal health officials announced a pilot program to accelerate early-stage clinical trials by six to 12 months, aiming to boost U.S.-based research and counter Chinese dominance. The initiative, part of a 2027 fiscal budget proposal, was supported by former FDA Commissioner Marty Makary and endorsed by Health Secretary Robert F. Kennedy Jr. in a Fox News op-ed.

The FDA will reconsider approving Regenxbio’s gene therapy for a rare childhood brain disorder, mucopolysaccharidosis type II (MPS II), after initially rejecting it four months ago. This follows recent FDA reversals, including allowing UniQure to resubmit a gene therapy application for Huntington’s disease previously rejected by former commissioner Marty Makary.

The FDA has reversed its opposition to UniQure's experimental Huntington’s disease treatment AMT-130, allowing the company to file for U.S. approval. UniQure plans to submit a marketing application in Q3 for accelerated approval, citing a three-year analysis of early-stage study data as acceptable to the FDA, despite previous objections from former agency officials.

The FDA approved Sanofi's teplizumab for children aged 8 and older with stage 3 diabetes. The drug underwent a speedy review program but the agency missed its decision deadline of April 21. Sanofi requested to withdraw the drug from the program after Tracy Beth Høeg, a former top drug regulator, disagreed with a staff approval decision.

The FDA has approved bemotrizinol, a sunscreen ingredient used abroad for decades, for use in the U.S. after it met safety and effectiveness standards. The ingredient will initially be sold as Parsol Shield by DSM Nutritional Products, with other manufacturers allowed to use it after an 18-month exclusivity period.

RevMed’s experimental pancreatic cancer drug, daraxonrasib, is available through an expanded access program but remains unapproved. The FDA’s voucher program led by Marty Makary may undergo changes.

The FDA is reviewing a drug approval program initiated by former commissioner Marty Makary after receiving mixed feedback, and has launched a safety study of the mifepristone abortion pill, potentially leading to distribution restrictions under the Trump administration. Antiabortion groups and Republican lawmakers supported the study, which is expected to take six months.

Leaders at the FDA held a listening session on the Commissioner’s National Priority Voucher program, which offers expedited drug reviews for companies aligning with vague national priorities. While some speakers supported the program, most urged the FDA to pause it and restart through standard regulatory processes due to concerns about political interference.

Eli Lilly is threatening to cut off price discounts from 340B hospitals that fail to submit required claims data, aiming to prevent duplicate discounts. The FDA is set to hold a closed-door meeting with rare disease advocates to discuss regulatory challenges for drug approvals.

The FDA relaxed oversight on wellness wearables, allowing products to market blood pressure and glucose readings without approval if labeled for wellness. Companies like Oura and Samsung have launched new features, while startups like Pin Pulse raise funds for similar devices. Experts warn of unproven technology risks despite potential benefits for hypertension awareness.

FDA senior officials were unexpectedly informed of new guidelines allowing unauthorized e-cigarettes and nicotine pouches to enter the U.S. market without full regulatory vetting. The policy bypassed standard procedures and internal consultation with tobacco enforcement experts, sparking confusion about its authorization and implementation.

Moderna's experimental mRNA flu vaccine (MFLUSIVA) will undergo FDA advisory panel review on June 18. This development follows the departure of former FDA head Marty Makary and signals a return to more stable regulatory processes for drug reviews.

FDA Commissioner Marty Makary was ousted along with Tracy Beth Høeg (CDER leader) and Katherine Szarama (CBER acting director), leaving three crucial FDA positions with only acting leadership. The simultaneous removal of these three high-ranking officials is characterized as an unprecedented ideological purge that has created significant instability within the agency.

Dr. Tracy Beth Høeg, former acting director of the FDA's Center for Drug Evaluation and Research, claimed she was fired, becoming the second high-ranking official to depart the FDA this week. Her departure follows that of former FDA Commissioner Dr. Marty Makary. Høeg will be replaced by her former deputy, Dr. Mike Davis.

Marty Makary resigned as FDA Commissioner, leaving a vacancy at the agency's top position. This comes after a year of significant changes, including an announcement about Covid-19 vaccine recommendations. The resignation follows a period of challenges for the agency's drug and biologics divisions.

Dr. Tracy Beth Hoeg, an FDA official, has been removed from her role leading the agency's drug program and will be replaced by Dr. Mike Davis. Hoeg was involved in scrutinizing the safety of COVID-19 vaccines and antidepressants. Her departure is the latest in an ongoing shake-up at the FDA.

The FDA is experiencing turmoil as top regulators, including Dr. Tracy Beth Høeg and Katherine Szarama, have left their positions, with Høeg claiming she was fired. The agency now lacks permanent leaders in key roles. This shake-up follows the resignation of Marty Makary.

The U.S. Food and Drug Administration is reorganizing its top drug and biologics regulators after the departure of former commissioner Marty Makary. This change occurs days after Makary's exit. The shuffle affects key leadership positions.

President Donald Trump's stance on flavored vapes has sparked backlash from some influencers and federal officials, including a response from FDA Commissioner Marty Makary. The discussion took place during a press conference at the White House. This event occurred in 2025.

Tracy Beth Høeg, acting director of the FDA's drug center, is leaving the agency, and Michael Davis will take over as acting director. This change comes after Commissioner Marty Makary resigned. The FDA is facing a leadership vacuum.

The FDA is easing restrictions on unauthorized vapes and scrapping a proposed ban on minors using tanning beds, which may weaken federal efforts to protect teens from unhealthy habits. The moves benefit the vaping industry, with the FDA authorizing its first fruit-flavored vaping products for adults. This decision has been met with opposition from public health experts and organizations.

The FDA's decision to withhold approval of a new skin cancer treatment has been met with criticism from doctors and patients, with some citing concerns about the agency's changed culture under Commissioner Marty Makary. The treatment, called RP1, had shown promise in prolonging the lives of some patients. The FDA's decision has raised questions about the agency's standards and processes.

The Supreme Court preserved women's access to the abortion pill mifepristone, rejecting lower-court restrictions while a lawsuit continues. The court's order allows women to continue obtaining the drug at pharmacies or through the mail without an in-person visit to a doctor. Access is likely to remain uninterrupted until next year as the case plays out.

The FDA is searching for its next leader. Marty Makary recently departed from the FDA. The full story about the hunt for the next FDA leader can be found on STAT+.

Dr. Marty Makary resigned as FDA commissioner on Tuesday via text message. A White House official confirmed the resignation to CNBC. The unusual method of resignation raises questions about professional protocol.

The Trump administration is searching for a new FDA commissioner after Marty Makary's resignation. The ideal candidate should rebuild trust with agency staff and focus on food policy and drug-approval reforms. This search follows three years of declining overdose deaths, sparking cautious optimism.

Kyle Diamantas is the new acting commissioner of the Food and Drug Administration, expected to bring stability to the agency. He previously served as the FDA's top food regulator. His appointment follows Marty Makary's resignation.

Marty Makary's resignation from the FDA may alleviate some pressure, but the next head will face similar challenges, including political interference and funding cuts. The new chief will have to navigate these issues while balancing demands related to healthcare. Makary's departure is a result of his embattled tenure as a health leader in the Trump administration.

The pharmaceutical industry is calling for stability and predictability from the next FDA commissioner after a tumultuous period. The CEO of PhRMA, Steve Ubl, and Bristol Myers Squibb CEO Chris Boerner emphasized the need for a stable FDA to ensure certainty in drug development. The industry is also pushing back against President Trump's 'most favored nation' pricing policy.

The Trump administration is searching for a new FDA commissioner after Marty Makary's resignation, seeking someone to rebuild trust and focus on food policy and drug-approval reforms. The search process is expected to take several weeks. The Senate's schedule and other confirmations may delay the appointment.

FDA Commissioner Marty Makary resigned, with President Trump thanking him for his work. Anti-abortion groups had previously called for Makary's removal over his stance on medication abortion access. Kyle Diamantas will serve as acting commissioner.

Marty Makary is resigning as FDA commissioner and Kyle Diamantas will step in as acting commissioner. This change occurs after President Trump confirmed Makary's resignation. The news impacts the leadership of the FDA.

US Food and Drug Administration Commissioner Marty Makary is resigning, with Kyle Diamantas stepping in as acting commissioner. Eli Lilly's weight loss pill Foundayo was found to have patients regain an average of 2-11 pounds after switching from injectable medications. The FDA has been marked by personnel drama and controversy over political pressure.

FDA Commissioner Marty Makary resigned and Kyle Diamantas will step in as acting commissioner. The resignation comes after speculation and criticism of Makary's performance. Matt Herper has expressed a strongly negative opinion of Makary's tenure.

Marty Makary's departure from the FDA creates uncertainty and may not solve organizational upheaval. The Senate will need to confirm another commissioner while considering other nominees. Makary's exit follows internal criticism and complaints about unpredictable regulatory decisions.

FDA Commissioner Marty Makary resigned amid pressure from anti-abortion groups criticizing his stance on medication abortion access. President Trump praised Makary's work and announced Kyle Diamantas as the acting commissioner. Makary's departure follows recent exits of other senior Trump administration officials.

Marty Makary stepped down as FDA Commissioner due to pressure and rumors about his job security, with Kyle Diamantas taking over as the agency's top food regulator. President Trump acknowledged Makary's difficulties in the role. The transition occurs ahead of Trump's trip to China.

Marty Makary resigned as Commissioner of the Food and Drug Administration after the Trump administration forced approval of fruity e-cigs, days after news broke that the White House had planned to fire him. Trump confirmed the resignation on social media, praising Makary's work at the FDA. Makary's resignation was effective immediately.

Marty Makary is considered the worst FDA commissioner in 25 years due to his lack of understanding of the agency's role and functions. He allowed senior leadership to leave, weakened standards, and ignored experienced staffers. Despite this, he had some positive efforts in areas like artificial intelligence in drug development.