Topic: FDA warning letter
Analysts are handicapping Teva's chance of getting its migraine drug candidate approved next week given issues at the plant that will produce it.
ADMA Biologics has its ducks in order to move forward with specialized plasma products that were sidelined by manufacturing issues.
The FDA's promo police are back in action with their fourth untitled letter of the year—and it's a second for Ascend Therapeutics.
Opdivo is priced in China at half its U.S. cost; Novartis names new chief for scandal-hit Korea unit; GSK's Indian consumer unit attracts new buyers.
A warning letter says a Japanese API maker admitted to the FDA that it had manipulated data during its API testing.
The FDA has banned products from a Chinese API maker after an inspection found serious problems in its manufacturing processes.
Former China FDA chief resigns over vaccine scandal; Astellas buys gene therapy specialist Quethera; FDA found problems at valsartan maker Huahai.
The FDA this month issued the Apotex Research Private plant in India a warning letter, its third in four years.
An FDA inspector didn’t have to spend long to discover that a Canadian API maker was failing to meet FDA standards.
A reinspection of Celltrion's South Korea plant resulted in another Form 483, but not a serious one.