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On December 28, the U.S. Food and Drug Administration reported there had been 50 novel drug approvals for the year, and that was just for new chemical entities.
The findings may have far-reaching consequences for any COVID-19 vaccines in development that are based upon targeting the well-conserved SARS-CoV-2 nucleocapsid (N-) protein.
Shares of Global Blood Therapeutics were up more than 10% in late-afternoon trading following regulatory approval of a supplemental New Drug Application for oral Oxbryta (voxelotor) tablets for the treatment of pediatric sickle cell disease.
Although the U.S. FDA largely cleared its calendar ahead of the holidays, it still has a couple open PDUFA dates leading up to January 1, 2022. Here’s a look.
It was an enormously busy week with plenty of announcements from the American Society of Hematology meeting and numerous companies working to get the news out ahead of the holidays and year-end. Here’s a look.
Full results from the Phase III trial of Novavax’s proposed COVID-19 vaccine demonstrated the drug’s efficacy in preventing mild, moderate, and severe illness.
Omega raised $650 million, which it plans to invest in life science companies in the U.S. and Europe.
Another flu season, another less than effective flu vaccine. The shape-shifting virus has mutated already and this year’s flu vaccine is a poor match to fight it.
Biogen and Eisai reported that the Committee for Medicinal Products for Human Use of the European Medicines Agency had decided not to recommend the drug for its MAA.
Biopharma companies are eying the establishment of new facilities across the globe that will bolster their manufacturing strategies. BioSpace rounds up some of the latest announcements.
In addition to showcasing data from their in-progress Phase I clinical trial, Kymera Therapeutics also announced their newest development program and outlined the company’s 5-year plan in their very first R&D Day.
With the holidays around the corner and people expected to gather, public health officials have expressed concerns over a possible increase in COVID-19 cases, particularly with the highly infectious Omicron variant on the rise.