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As U.S. vaccinations against COVID-19 gain momentum, health officials are using new tools to gather postmarket safety data, including a new early warning system called V-Safe. Read More
The FDA announced that it is developing guidance 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
Like other parts of the FDA, the Center for Drug Evaluation and Research had to scramble last year to address COVID-19 while not losing sight of its other important tasks, according to its latest annual report on Drug Safety Priorities. Read More
In just over four months, drug manufacturers will experience a change in the FDA’s online adverse event report system to help the agency figure out what stage the product the adverse event is associated with has reached. Read More
New treatments for cancer, hereditary angioedema and spinal muscular atrophy may be available to European patients soon, as the European Medicines Agency’s Committee for Medicinal Products for Human Use (EMA/CHMP) recommended that the agency approve six new drugs, including two biosimilars and one generic, at its four-day meeting last week. 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
Federal assessment of the API supply chain “will complement the ongoing work to secure supply chains needed to combat the COVID-19 pandemic,” the White House said. 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
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