A generics maker in the U.K. had its manufacturing certification pulled after regulators found data-reporting issues.
The FDA has classified the ongoing recall by drug wholesaler Truxton of 18 lots of phenobarbital and amitriptyline tablets as Class I and Class II recalls.…
Clinical care experts and patient advocacy organizations call attention to why better patient understanding shapes the best integrated approach to orphan drug…
The FDA slapped Foshan Flying Medical with a warning letter for inadequate testing, validation and training issues at its plant in Guangdong, China.
The FDA bit into homeopathic pharmaceutical manufacturer Homeolab USA over belladonna-treated teething products that CVS took off the shelf last year.
Brought to you by the publisher of FierceBiotech and FiercePharma, the Fierce Innovation Awards Life Sciences Edition identify and showcase outstanding…
The FDA has warned of potential contamination of a number of brands of drugs and dietary supplements manufactured by PharmaTech.
German regulators have pulled the manufacturing certificate for Dr. Reddy’s formulation plant in India.
The Biocon sterile manufacturing plant that got spanked by European and FDA regulators earlier this year has taken another whipping by the FDA.
The FDA has slapped an Italian sterile manufacturer with a warning letter pointing to the contamination hazards tied to its highly manual processes.
Baxter Pharmaceutical is voluntarily recalling sodium chloride dextrose units due to a lack of assurance of sterility and the possibility of leakage.
Mylan and Biocon have hit a stumbling block that will delay potential approval of their biosimilar of Roche’s Herceptin in Europe.