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Despite the serious challenges the FDA faced in responding to the COVID-19 pandemic in 2020, the agency ended the year approving more novel drugs than in four of the five previous years. Read More
India on Sunday granted emergency use approval for the COVID-19 vaccine co-developed by AstraZeneca (AZ) and Oxford University — formerly known as AZD1222 but now called COVID-19 Vaccine AstraZeneca — along with a separate vaccine, Covaxin, developed by Bharat Biotech. Read More
On Wednesday, the UK authorized AstraZeneca’s (AZ) and Oxford University’s COVID-19 vaccine for emergency use, characterized as a rapid temporary regulatory approval, becoming the first country to do so as the nation contends with a new contagious strain of the virus leading to a spike in cases. Read More
The blockbuster drug is the first poly (ADP ribose) polymerase (PARP) inhibitor approved in Japan for treating three specific types of cancer. Read More
The FDA has given the green light for the first generic version of glucagon for injection, a drug that’s long been approved for treating severe hypoglycemia (very low blood sugar) that may occur in diabetes patients. Read More
AstraZeneca’s (AZ) and Oxford University’s coronavirus vaccine may earn its first authorization this week if the UK or India moves to clear it as anticipated, but it’s unlikely to see emergency clearance in the EU until at least February, a European Medicines Agency (EMA) official said. Read More