The number of drug units impacted by recalls in the second quarter of 2022 was slashed by more than half — from 435.3 million units recalled in Q1 to 20.6…

Astellas Pharma got an FDA green light last week when the agency accepted its New Drug Application (NDA) for fezolinetant — potentially the first-ever nonhormonal drug for hot flashes associated…

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 —…

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…

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…

It’s not just academia- and industry-funded trials that are lacking in transparency; a recent audit by the Office of Inspector General (OIG) has found that the National Institutes of Health…

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…