FDA approval was swiftly followed by CDC advisory committee recommendation of the XBB.1.5. variant-based vaccines for all people aged 6 months and older.
Following an efficient one-two regulatory punch by the US Centers for Disease Control & Prevention and the US FDA, 2023-2024 COVID-19 vaccines based on the Omicron variant XBB.1.5 will be available later in the week with a recommendation for use by everyone 6 months of age and older.
The FDA approved and authorized the Moderna and Pfizer/BioNTech 2023-2024 COVID-19 vaccines on 11 September, conveniently one day before the...
Upcoming FDA user fee goal dates include novel products from a busy lung cancer pipeline, a single-dose passive immunization against RSV for infants, what could be the first oral HAE acute treatment, and a first-in-class HAE preventive antibody.
The Pink Sheet's list of EU centralized approvals of new active substances has been updated to include two new products, one of which is Vyjuvek, Krystal Biotech's advanced therapy for treating dystrophic epidermolysis bullosa.
The European Medicines Agency has OKd 10 new medicines for EU-wide approval, including a CAR-T therapy for treating acute lymphoblastic leukemia. Two drugs were, however, rejected.
In the infrequent cases when EU authorization precedes US FDA approvals of new products, biologics manufacturing issues are usually to blame, a Pink Sheet analysis found.
The European Medicines Agency says that a regulatory reliance pilot that it is supporting to speed up assessments of post-approval changes appears to be accelerating evaluation timelines in non-EU countries.
The Pink Sheet's list of EU centralized approvals of new active substances has been updated to include two new products, one of which is Vyjuvek, Krystal Biotech's advanced therapy for treating dystrophic epidermolysis bullosa.
The first 100 days of the Trump Administration were notable for an extraordinary decline in the number of public meetings hosted by the US Food and Drug Administration. But the schedule changed quickly.
