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Bristol Myers Squibb (BMS) has reported positive findings from two late-stage clinical trials of deucravacitinib, its experimental treatment for moderate-to-severe plaque psoriasis. Read More
As work continues on remedying a host of concerning issues at Emergent BioSolutions’ Bayview, Md., facility, Health Canada has reported that the 1.5 million AstraZeneca (AZ) doses it received from the site were up to par for safety and quality. Read More
The Biden administration has decided to begin sharing its AstraZeneca (AZ) vaccine supply with the rest of the world while the shots go unused in the U.S., as the government also begins delivering supplies of raw materials needed to make the vaccine in COVID-ridden India. Read More
The FDA on Friday amended its Emergency Use Authorization (EUA) for the Johnson & Johnson COVID-19 vaccine to reflect the risk of rare blood clots and said vaccinations could resume immediately, based on recommendations by a Centers for Disease Control and Prevention (CDC) advisory committee. Read More
Biogen has been gearing up for a U.S. rollout of its controversial, closely-watched Alzheimer’s drug candidate aducanumab despite lingering questions about its chances of FDA approval that will finally be put to rest by the agency’s June 7 target date. Read More
The European Medicine Agency’s Committee on Medicinal Products for Human Use (CHMP) recommended eight drugs for approval at its April meeting, including two generics. Read More
The European Medicines Agency (EMA) has approved the scale-up of manufacturing of messenger RNA-based COVID-19 vaccines from Pfizer/BioNTech and Moderna to increase supply to the EU, which now appears to be strongly favoring mRNA vaccines over viral vector-based products from AstraZeneca and Johnson & Johnson. Read More
Hiring and retention of FDA talent needed for PDUFA VII reviews were a focus of several meetings of a PDUFA finance subgroup, according to recently posted FDA meeting summaries from January and February. Read More