Topic: FDA warning letter
China fines vaccine scandal-hit Changsheng $1.3 billion; Merck and Samsung bail on a Lantus biosim; Taiho grows VC fund to sixfold.
The FDA OPDP slapped a warning letter on Mannkind for failing to mention Afrezza's risks.
The FDA, which banned products from a South Korean sterile manufacturer last spring, has now followed up with a warning letter.
The FDA said it uncovered a second and unexpected cancer-causing impurity in three batches of the blood pressure medicine valsartan that were sold by Torrent Pharmaceuticals.
India’s Sun Pharmaceuticals, which is working to shift its focus to novel and specialty drugs, has won FDA approval of a new treatment for glaucoma.
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.