MATTHEW PERRONE Health Writer, Author at The Rapid City Post

In this undated photo provided by the U.S. Food and Drug Administration, Vinay Prasad smiles for a portrait. (U.S. FDA via AP)

FDA vaccine chief leaving agency after less than 3 months

July 30, 2025

Dr. Vinay Prasad is stepping down as the Food and Drug Administration’s top vaccine regulator after a brief tenure. A spokesperson for the Department of Health and Human Services says Prasad did not want to be a distraction and is leaving to spend more time with his family. Prasad, a longtime critic of the FDA’s leniency in drug approvals, joined the agency in May. He has faced scrutiny over his handling of a gene therapy for a form of muscular dystrophy. In recent weeks he became a target of conservative activists, who noted his past comments criticizing Trump.

Sarepta will resume gene therapy shipments after FDA review of recent patient death

July 28, 2025

Shares of drugmaker Sarepta Therapeutics surged in afterhours trading Monday after the company said it would resume shipping its gene therapy. The company’s stock has been under pressure for weeks after a series of patient deaths prompted federal regulators to request a pause on the drug’s use. Elevidys is the first gene therapy approved in the U.S. for Duchenne’s muscular dystrophy, the fatal muscle-wasting disease that affects boys. The Food and Drug Administration said late Monday it recommended resuming shipments for some patients after reviewing the situation. The review included the conclusion that the recent death of an 8-year-old boy was unrelated to the company’s therapy.

FILE - The Food and Drug Administration seal is seen at the Hubert Humphrey Building Auditorium in Washington, Tuesday, April 22, 2025. (AP Photo/Jose Luis Magana, File)

Sarepta shares slide again as drugmaker bows to FDA pressure to pause gene therapy

July 22, 2025

Sarepta Therapeutics is pausing shipments of its gene therapy for muscular dystrophy following several patient deaths that have attracted attention from regulators. The company said late Monday it would comply with a Food and Drug Administration request to halt distribution of Elevidys. The decision comes just days after the company rebuffed FDA regulators in an extremely unusual decision. Elevidys is the first gene therapy approved in the U.S. for Duchenne’s muscular dystrophy. The fatal muscle-wasting disease affects boys and young men, resulting in early death. Company shares continued to slide in early trading Tuesday morning.

FDA names former pharmaceutical company executive to oversee US drug program

July 21, 2025

The Food and Drug Administration named a longtime pharmaceutical executive to run the agency’s drug program. Dr. George Tidmarsh is the founder and former CEO of several drugmakers. He was named Monday to run the FDA’s center for drugs, which employees nearly 6,000 staffers. His appointment comes a month after the center’s acting director announced her retirement. As the agency’s top drug regulator, Tidmarsh would be tasked with following through on a number of commitments by the Trump administration. That includes reviewing the 25-year-old approval of the abortion pill mifepristone.

Gene therapy maker Sarepta tells FDA it won’t halt shipments despite patient deaths

July 19, 2025

Drugmaker Sarepta Therapeutics says it won’t comply with a request from U.S. regulators to halt all shipments of its gene therapy. The Food and Drug Administration made the request Friday after the confirmation of a third death receiving one of its treatments for muscular dystrophy. The company’s decision not to comply is highly unusual. The FDA says officials met with Sarepta executives and requested the halt in sales. Sarepta says in a statement that its scientific review showed no new safety concerns for younger patients with Duchenne’s muscular dystrophy. The company said it plans to keep the drug, Elevidys, available for those patients.

FDA requires updated warning about rare heart risk with COVID shots

June 25, 2025

U.S. health officials have expanded warnings about a rare heart side effect associated with the two leading COVID-19 vaccines. The Food and Drug Administration announced the update Wednesday, providing more detail about the problem and the number of people who may be affected. Pfizer and Moderna have added the information to their labels and pamphlets for patients. Myocarditis, a type of heart inflammation that is usually mild, emerged as a rare effect with the first COVID-19 shots, mainly in boys and young men. Earlier vaccine labeling advised doctors about the issue. The new warning covers a larger group.

FILE - Food and Drug Administration (FDA) commissioner Marty Makary speaks during a news conference at the Hubert Humphrey Building Auditorium in Washington, April 22, 2025. (AP Photo/Jose Luis Magana, file)

FDA to offer faster drug reviews to companies promoting ‘national priorities’

June 17, 2025

The Food and Drug Administration says it will begin offering faster reviews to new medicines that align with Trump administration priorities for Americans’ health. The new program announced Tuesday aims to review select drugs in just one to two months. It was announced by FDA Commissioner Marty Makary, who has promised “faster cures” since arriving at the agency in April. Makary says the FDA will begin offering special vouchers to drugmakers who are “aligned with U.S. national priorities.” The FDA already has a variety of programs designed to speed up drug reviews, but they all have fairly strict medical criteria.

FILE - The U.S. Food and Drug Administration campus in Silver Spring, Md., is photographed, Oct. 14, 2015. (AP Photo/Andrew Harnik, File)

Second patient death reported with gene therapy for muscular dystrophy

June 16, 2025

Shares of Sarepta Therapeutics have plunged again after the drugmaker reported a second death in connection with its gene therapy for muscular dystrophy. The biotech drugmaker said Sunday it was pausing shipments of the drug for patients who are no longer able to walk. The one-time treatment is the first gene therapy approved in the U.S. for the rare muscle-wasting condition. The company has faced scrutiny since its accelerated approval in 2023. Sarepta says it will pause a study of the therapy and assemble an expert panel to recommend new safety protocols for taking the drug.

This photo provided by the FDA in January 2024 shows bottles of Neptunes Fix Elixir, a product labeled to contain tianeptine. (FDA Office of Regulatory Affairs, Health Fraud Branch via AP)

‘Gas station heroin’ is technically illegal and widely available. Here are the facts

June 14, 2025

Health officials want you to think twice before buying brightly colored energy shots and supplements often sold at gas stations, convenience stores and smoke shops. The products are sometimes called “gas station heroin,” and contain tianeptine. That’s an antidepressant that can be addictive and carries the risk of serious side effects. U.S. poison control centers have reported a steady rise in calls linked to the drug for more than a decade. The drug has never been approved by the FDA for any medical condition in the U.S. and cannot legally be added to foods and beverages or sold as a dietary supplement. About a dozen states have prohibited or restricted tianeptine.

MATTHEW PERRONE Health Writer.

FDA vaccine chief leaving agency after less than 3 months

Sarepta will resume gene therapy shipments after FDA review of recent patient death

Sarepta shares slide again as drugmaker bows to FDA pressure to pause gene therapy

FDA names former pharmaceutical company executive to oversee US drug program

Gene therapy maker Sarepta tells FDA it won’t halt shipments despite patient deaths

FDA requires updated warning about rare heart risk with COVID shots

FDA to offer faster drug reviews to companies promoting ‘national priorities’

Second patient death reported with gene therapy for muscular dystrophy

‘Gas station heroin’ is technically illegal and widely available. Here are the facts

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