The US Food and Drug Administration (FDA) granted approval for a second treatment for metabolic dysfunction-associated ...

Darzalex Faspro's supply and availability remain unaffected, and no new clinical studies were requested by the FDA.

PTC Therapeutics has not provided substantial evidence that vatiquinone is effective in treating children and adults with Friedreich’s ataxia, the FDA told the company in a complete response letter, ...

A report by the Queensland Productivity Commission recommended the state should opt out of the National Construction Code's ...

The regulatory body determined that PTC Therapeutics’ New Drug Application for vatiquinone did not provide sufficient ...

PTC Therapeutics yesterday revealed that the US Food and Drug Administration (FDA) has issued a Complete Response Letter (CRL ...

"We are, of course, disappointed by the FDA's decision to not approve vatiquinone," said Matthew Klein, PTC's chief executive, who noted that the FDA is seeking another 'adequate and well-controlled' ...

The US Food and Drug Administration (FDA) has rejected PTC Therapeutics’ new drug application (NDA) for vatiquinone in ...

Lexeo Therapeutics Inc. (NASDAQ:LXEO) is one of the best IPO stocks to buy according to Wall Street analysts. Earlier on July ...

Today, the FDA issued a complete response letter (CRL) for vatiquinone (PTC Therapeutics), delaying its potential approval as a treatment for Friedreich ataxia amid efficacy concerns.

The original NDA submission included data from the registration-directed phase 3 MOVE-FA trial as well as 2 long-term studies evaluating vatiquinone in FA.

The U.S. Food and Drug Administration has denied approval for PTC Therapeutics' oral medication for a rare genetic disorder ...