CHMP upheld earlier opinions that Translarna is not of significant benefit to DMD due to nonsense mutations; European ...

Leerink Partners analyst Joseph Schwartz has maintained their neutral stance on PTCT stock, giving a Hold rating on October 11. Joseph ...

After hitting a wall with the FDA last year, Novo Nordisk has picked up backing from European drug reviewers for its novel ...

PTC Therapeutics (PTCT) announced that the Committee for Medicinal Products for Human Use of the European Medicines Agency has ...

PTC Therapeutics has suffered another setback in its bid to keep its Duchenne muscular dystrophy drug Translarna on the market in Europe. PTC on Friday said the European Medicines Agency's Committee ...

The first bispecific antibody to win regulatory approval is about to make a comeback 10 years after being taken off the market in Europe for commercial reasons. Catumaxomab, then called Removab, and ...

EMA re-confirms non-renewal of conditional marketing authorisation of Duchenne muscular dystrophy medicine, Translarna: Amsterdam, The Netherlands Monday, October 21, 2024, 10:00 ...

In draft guidance published on Friday, it emerged NICE does not recommend PTC Therapeutics’ Translarna (ataluren) for the treatment of Duchenne muscular dystrophy (DMD) caused by a nonsense ...

"CHMP again based its decision on the results of the primary analysis subpopulation of Study 041 instead of the totality of evidence for Translarna. That evidence includes data across three ...

European regulators have for the fourth time issued a negative opinion on PTC's Translarna. Elsewhere, Amylyx read out data ...

Last week’s significant news included Denmark-based CNS drugmaker Lundbeck reaching agreement to acquire US firm Longboard ...

PTC Therapeutics, Inc. (NASDAQ: PTCT) announced today that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency has maintained its negative opinion on the renewal ...