We use cookies to provide you with a better experience. By continuing to browse the site you are agreeing to our use of cookies in accordance with our Cookie Policy.
CP Pharmaceuticals, a subsidiary of drug manufacturer Wockhardt Limited received a warning letter that inspection of its facility revealed significant GMP violations. Read More
Antera Therapeutics has drawn FDA scrutiny for marketing and selling Aralyte, a kit of capsules filled with liquid peanut protein, as a preventative treatment to keep children from developing peanut allergies. Read More
The FDA rejected Spectrum Pharmaceuticals’ Qapzola, a treatment for non-muscle invasive bladder cancer, the company said following receipt of a CRL. Read More
The FDA’s new Inspection Protocol Project is expected to increase the likelihood of a drug manufacturing facility undergoing a pre-approval inspection from the current 30 percent to a target of 50 percent. Read More
Nicox, an international ophthalmic R&D company, announced it received a complete response letter related to its NDA for its cetirizine eye drop formulation AC-170. Read More
Syntese has received a Form 483 after an inspection revealed sanitation, quality and laboratory control issues at the Denmark-based API maker. Read More
UK-based Wallace Cameron International has not fulfilled its registration obligations to continue manufacturing and exporting drugs to the United States, the FDA said. Read More
A pharmaceutical company in Beijing has received a warning letter from the FDA after barring investigators from the facility as well as falsifying and back-dating records. Read More