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An independent expert panel of the FDA voted 7-2 Tuesday to allow Roche’s Tecentriq (atezolizumab) to remain approved for treating PD-L1-positive unresectable locally advanced or metastatic triple-negative breast cancer (TNBC) alongside nab-paclitaxel as further trial data are generated. Read More
Exela Pharma Sciences drew a warning letter from the FDA for inadequate procedures for reporting adverse events and other lapses observed during an agency inspection of its drug outsourcing facility in Lenoir, North Carolina. Read More
The European Medicines Agency (EMA) has released new guidance on the use of good manufacturing practices (GMPs) in the production of biological starting materials for advanced therapy medicinal products (ATMPs). 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
Public Citizen says “the agency was aware of evidence from a major clinical trial that raised substantial doubts about whether the drug provides clinically meaningful benefit.” Read More