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A single dose of the Pfizer/BioNTech vaccine significantly lowers asymtopmatic SARS-CoV-2 infections, which means it also reduces the risk of transmission from asymtopmatic individuals, a new UK study has shown. Read More
The Biden administration has secured 100,000 doses of Eli Lilly’s combination monoclonal antibody (mAB) treatment to be delivered through March 31, with an option to buy an additional 1.1 million doses through November of this year. But will hospitals and outpatient centers even use them? Read More
In a 219-212 vote along party lines on Saturday, the House of Representatives passed the massive $1.9 trillion COVID-19 relief bill that includes $500 million in extra funding for the FDA and the elimination of Medicaid drug pricing rebate caps starting in 2023. Read More
The FDA granted an Emergency Use Authorization (EUA) for a third COVID-19 vaccine Saturday, clearing Johnson & Johnson’s (J&J) single shot following unanimous support from its vaccines advisory panel. Read More
The European Commission (EC) has agreed on a common framework for the use and validation of rapid antigen tests and COVID-19 test results that EU member states will mutually recognize, as well as a standardized dataset to be included in test result certificates. Read More
Merck plans to acquire Massachusetts-based Pandion Therapeutics for an estimated $1.85 billion to broaden its portfolio of autoimmune disease therapies. Read More
The FDA sent letters to two companies Feb. 17, withdrawing part of the approvals it had granted them for their hemophilia products last year in response to their supplementary biologics license applications, due to the agency overlooking a pediatric exclusivity designation that is still in effect. Read More
A new UK study has found that statins did not have any overall effect on muscle symptoms in patients who had previously reported them when taking the medications, suggesting that statins may not responsible for the muscle pains associated with taking them. Read More
The European Medicines Agency (EMA) has issued new guidance outlining requirements for drug manufacturers that modify their COVID-19 vaccines to protect against several emerging variants to SARS-CoV-2. Read More
The FDA has announced that it is working on guidance for states and for compounders on compounding drugs during the COVID-19 pandemic to protect patients from “unsafe, ineffective and poor-quality compounded drugs, while preserving access for patients.” Read More
The FDA has approved Pfizer’s and BioNTech’s request for a revised Emergency Use Authorization (EUA) permitting their COVID-19 vaccine to be stored at normal pharmaceutical freezer temperatures. Read More