Endo says it has dropped its $190 million buyout of sterile injectables company Somerset Therapeutics as approvals from India became uncertain.
The FDA keeps rolling through the Indian manufacturing plants of Dr. Reddy’s Laboratories, and the Form 483s keep falling out.
The power struggle at Sinovac has taken another unusual turn with the company's move to implement a "poison pill" defense.
The FDA has made another trip to the key Aurobindo sterile manufacturing facility in India and has again found it lacking.
Chinese authorities have approved Fosun subsidiary Henlius' Rituxan copycat, the country's first biosimilar.
FDA Commissioner Scott Gottlieb, M.D., again turned to Twitter to defend the quality of the U.S. drug supply and the agency’s record of keeping it safe.
GSK sells Indian vaccine subsidiary to Bharat; Dr. Reddy's rides a turbulent week; Sandoz sells more U.S. generics.
Just days after bad news about manufacturing wreaked havoc with Dr. Reddy’s shares, the drugmaker was able to report something positive.
After the buy, Bharat Biotech will be able to make 25 million doses of rabies vaccine each year, its chairman said.
AZ's China sales jumped 25% in 2018; Pfizer Japan recalls valsartan drugs made with Mylan's API; resistance might hurt Shionogi and Roche's…