Topic: Form 483

Daiichi and AZ's Enhertu as well as and Astellas and Seattle Genetics' Padcev won FDA nods as China approved rivals to Prevnar and Gardasil.

After years of criticism from the FDA, Sun’s Halol plant still can’t get through an FDA inspection without the agency finding some deficiency.

Catalent has been picked to manufacture BeiGene's immuno-oncology drug.

Amgen pays $2.7 billion for a 20.5% stake in BeiGene. AstraZeneca tightens its ties to China as China approves a controversial Alzheimer's drug.

India’s Aurobindo, which has yet to close its $1 billion deal to buy 300 Sandoz products in the U.S., continues to rack up FDA issues.

Aurobindo and Glenmark are cited by the FDA. Takeda inks IBD discovery pact with Prometheus. Ascletis recruits Novartis veteran as CSO.

India’s Aurobindo, which has been racking up FDA actions right and left, acknowledged Monday a recent agency inspection resulted in a Form 483. 

After some recalls of defective creams, India's Glenmark has received a warning letter for the plant where they were manufactured.

Novartis is putting the quality teams at gene therapy biotech AveXis under parental control after being embarrassed by a data manipulation scandal.

BeiGene rebuffs claims that it inflated drug sales records; Sumitomo Dainippon pays $3 billion upfront for five "vants"; Genentech settles with JHL Biotech.