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Signa, a Mexican subsidiary of Canadian generic drugmaker Apotex, has received an FDA warning letter for failure to correct manufacturing problems for active pharmaceutical ingredients (API) that were later released into the U.S. market. Read More
Gilead Sciences said it is buying a 49.9 percent stake in Tizona Therapeutics, a company developing first-in-class cancer immunotherapies, for $300 million in a transaction expected to close in the third quarter of this year. Read More
HHS and the Department of Defense have signed their largest deal to date under Operation Warp Speed — a $1.95 billion contract with Pfizer and BioNTech for large-scale production and nationwide delivery of 100 million doses of their COVID-19 vaccine. Read More
The FDA has slapped Eosera with a Form 483 after finding the over-the-counter (OTC) ear-care product manufacturer failed to validate drug products and properly investigate bacterial contamination. Read More
Acadia Pharmaceuticals’ Nuplazid (pimavanserin) failed to meet its primary endpoint in two phase 3 clinical trials evaluating it for major depressive disorder. Read More
Clinical research on human drugs that contain cannabis can be conducted legally as long as the amount of the substance in the investigational product is within limits set by a new FDA draft guidance. Read More