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FDA, drug review

Former biotech executive appointed to lead FDA drug office

George Tidmarsh, a Stanford University physician who founded Horizon Pharma and later ran La Jolla Pharma, was named head of the Center for Drug Evaluation and Research.

The Associated Press on MSN · 1d

FDA names former pharmaceutical company executive to oversee US drug program

FDA Commissioner Marty Makary announced that Dr. George Tidmarsh, a cancer and pediatric specialist, will direct the agency’s Center for Drug Evaluation and Research, which regulates the safety and effectiveness of all U.S. drugs.

Politico · 1d

Makary ally named to key FDA drug post

Dr. George Tidmarsh, a Stanford pediatrics adjunct professor and former pharmaceutical executive, is FDA Commissioner Marty Makary’s pick to be the nation’s top drug regulator.

FDA, Sarepta and Ohio

The Columbus Dispatch on MSN · 22h

Sarepta Therapeutics laying off dozens in Ohio, won't comply with FDA request to halt therapy

After the FDA request, Cambridge, Massachusetts-based Sarepta said in a statement that it will continue to ship the therapy to ambulatory people but maintain a halt it implemented June 15 for non-ambulatory patients after reporting to the FDA a case of acute liver failure in a patient who could not walk.

Hoodline · 3d

Sarepta Therapeutics Announces Layoff of 493 Employees, Including 80 in Ohio, Amid FDA Scrutiny and Stock Decline

Sarepta Therapeutics lays off 493 workers amid FDA probe, stock drop, and concerns over its gene therapy treatment, Elevidys.

Fierce Pharma · 2d

Sarepta stands behind Elevidys after FDA requests gene therapy be pulled from market

As the controversy over the safety of Sarepta Therapeutics’ gene therapies comes to a head, the biotech is standing firm behind its approved Duchenne muscular dystrophy (DMD) treatment. | As the controversy over the safety of Sarepta Therapeutics’ gene therapies comes to a head,

BioSpace6h

Sarepta’s Wild Week, CDER’s New Leader, FDA Rejections, Manufacturing Billions

Sarepta Therapeutics faces serious FDA action after news broke of a third patient death, the FDA gets a new top drug ...

16don MSN

FDA Layoffs Could Compromise Safety of Medications Made at Foreign Factories, Inspectors Say

For years, inspectors have uncovered dirty equipment, contaminated supplies and fraudulent testing records in some overseas factories — serious safety and quality breaches that can sicken or kill ...

STAT16d

Inside the staff exodus and tanking morale that threaten Makary’s FDA

WASHINGTON — The steady erosion of experienced staff at the Food and Drug Administration is slowly compromising the agency’s ...

BioSpace7d

FDA Layoffs, 200 Rejection Letters, User Fees and Priority Vouchers, Bad Week for Rare Disease

Around 3,500 FDA employees received termination emails; FDA Commissioner Marty Makary suggests lowering industry user fees ...

Becker's Hospital Review15d

Drug inspectors warn of slower checks following FDA layoffs

Cuts at the FDA are slowing inspections of overseas drug manufacturers, prompting concerns from former and current employees that medication safety could be at risk, ProPublica reported July 7. Dozens ...

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