Topic: FDA warning letter
The FDA hit New Jersey-based CMO Tris Pharma with a warning letter, citing significant violations.
Celltrion remains optimistic it will get U.S. approval for its two biosimilar drugs, Rituxan and Herceptin, by the end of the year.
The FDA issued a warning letter to Labocont Industrial following an inspection last year and cited the company for failing to make fixes.
6 Dimensions makes a slew of biotech investments; Sun Pharma wins FDA nod for Ilumya; China plans 'zero tariff' policy on cancer drugs.
The FDA has issued India's Malladi Drugs & Pharmaceuticals a warning letter and banned its products from the U.S. until it can vastly improve.
The FDA has issued a warning letter to French drug testing lab Quali-Controle, saying some of its testing methods are unvalidated.
China FDA will take a new form; Celltrion's manufacturing issues might be worse than Teva hoped; Wuxi NextCODE and Google Cloud partner up.
The FDA issued a warning letter to Nan San Pharmaceutical for failing to conduct appropriate laboratory testing and marketing misbranded products.
Merck gets half of Lenvima's sales in $5.8 billion deal; Juno and WuXi's CAR-T JV got $90 million; FDA approved Taiwanese firm's HIV drug.
The FDA issued a warning letter to Chinese OTC drugmaker Zhejiang Ludao Technology, citing data integrity and product testing issues.