Despite getting a renewed green light from the FDA, Homology Medicines is putting the brakes on its phase 2 trial of a gene therapy for phenylketonuria (PKU) and shifting resources…

A federal court judge in Delaware has ruled in favor of Exela Pharma Sciences on all counts in a patent dispute over Eton Pharmaceuticals’s abbreviated new drug application (ANDA) to…

The FDA has accepted Glaxo Smith Kline’s New Drug Application for momelotinib, just months after the behemoth snapped up the investigational myelofibrosis drug and the company that developed it —…

The FDA issued a warning letter to Verde Cosmetics of Northridge, Calif., for failing to conduct microbiological testing of its topical drugs and lacking adequate cleaning procedures. Source: Drug Industry…

Blueprint Medicines has enough pivotal data in hand to seek a new indication for Ayvakit (avapritinib) as a treatment for nonadvanced systemic mastocytosis and plans to file a supplemental new…

The FDA has approved Bluebird Bio’s Zynteglo (betibeglogene autotemcel) for the treatment of adult and pediatric patients with beta-thalassemia who require regular red blood cell transfusions. Source: Drug Industry Daily

With the announcement of a failed phase 3 breast cancer trial hot on the heels of a negative phase 2, Sanofi has decided to pull the plug on amcenestrant, an…

Piling more criticism on the already-embattled Emergent Biosolutions, the FDA has issued a warning letter citing significant sterility issues at the company’s Camden facility in Baltimore, Md., and stating that…

Drug and biologics manufacturers submitting electronic individual case safety reports (ICSR) and ICSR attachments to the FDA Adverse Event Reporting System database should follow a new technical guide the agency…

Merck and Orna Therapeutics announced that they are joining in a new partnership to advance development of the Cambridge, Mass., startup company’s RNA and lipid nanoparticle delivery platform to treat…