Topic: FDA warning letter
The FDA slapped a warning letter on an Indian drugmaker after first banning its products for failing some basic FDA manufacturing standards.
Yinghua Biochemical and Pharmaceutical Co. was issued a warning letter by the FDA for data integrity issues and problems with its quality unit.
Shire nixed Takeda's $60 billion-plus buyout offer, Hanmi ditched lung cancer hopeful olmutinib, Grail is looking for $1 billion before Hong Kong IPO.
McCallum was hit with a warning letter from the FDA for testing issues with its products and failing to keep appropriate records.
The FDA issued a warning letter to Hong Kong-based over-the-counter drugmaker Luen Wah Medicine, citing the company for not testing the identity and strength of each active ingredient in its products.
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.