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Merck announced yesterday that it is discontinuing its phase 3 nonsmall-cell lung cancer trial of Keytruda (pembrolizumab) in combination with Bristol Myers Squibb’s (BMS) Yervoy (ipilimumab), citing an unfavorable benefit-risk profile. Read More
An FDA inspection of Romark Global Pharma’s Manati, Puerto Rico drug manufacturing facility revealed problems with contamination of drug products and equipment. Read More
The FDA issued warning letters to four topical drug manufacturers in Mexico for using unapproved ingredients in their hand sanitizer products. Read More
FDA investigators cited five drug facilities for failures ranging from late field reports to lax control of data, complaint handling and training. Read More
The FDA issued warning letters to three drug manufacturing facilities for failures in their current good manufacturing practices, including lax environmental monitoring and inadequate process validations. Read More
Owen Biosciences, an over-the-counter drug manufacturer in Baton Rouge, La., has been sent a Form 483 inspection report from the FDA detailing observations about good manufacturing practices at the company’s facility. Read More
Over the counter (OTC) drugmaker Cosmax USA may have distributed batches of its product contaminated with dangerous bacteria, the FDA said in a warning letter to the Ridgefield Park, N.J. company. Read More
UCSF Radiopharmaceutical Facility drew a lengthy inspection report from the FDA for failing to fully investigate out-of-specification results and other quality lapses. Read More
Shilpa Medicare of Karnataka, India, drew a warning letter from the FDA for multiple violations found during an inspection of its sterile drug manufacturing facility. Read More
Generics manufacturer KVK-Tech was slapped with another warning letter from the FDA over violations at a Newtown, Pennsylvania facility, its second of the year. Read More
The FDA cited MasterPharm following an inspection of its South Richmond Hill, N.Y. plant that revealed numerous violations of current good manufacturing practices. Read More