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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
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
Significantly more hospitalized COVID-19 patients aged 70 and up were alive and free of respiratory failure after treatment with GlaxoSmithKline’s (GSK) investigational monoclonal antibody otilimab in a phase 2 clinical trial, the company said Thursday. Read More
As Teva Pharmaceuticals tries to convince the full U.S. Court of Appeals for the Federal Circuit to reconsider its earlier judgment that it has to pay $235.5 million in damages to GlaxoSmithKline (GSK) for patent infringement, oral arguments this week left it unclear whether the final decision will be any different. Read More
President Biden signed an executive order Wednesday mandating a review of the U.S. supply chain for critical goods, including materials needed for manufacturing COVID-19 products — fulfilling a promise he made on the campaign trail. Read More
Senate hearings for HHS Secretary nominee Xavier Becerra, California’s attorney general, concluded Wednesday in the Senate Finance Committee, where Becerra was questioned by senators — and at times heatedly by Republican lawmakers — on a range of healthcare issues including drug pricing, drug shortages and intellectual property protections. Read More
The FDA has published a briefing document ahead of Friday’s advisory panel meeting showing that agency staff have found the promising, single-shot Johnson & Johnson COVID-19 vaccine safe and effective enough for Emergency Use Authorization (EUA). Read More