by Jordana Choucair | Dec 3, 2021 | Life Sciences
Robert Califf, President Biden’s nominee to lead the FDA, asked Dr. Janet Woodcock, the agency’s acting commissioner, to stay on if he’s confirmed by the Senate. The Senate has not yet set a confirmation hearing for Califf. It is also not yet clear...
by Jordana Choucair | Dec 2, 2021 | Life Sciences
A federal appeals court on Wednesday dismissed two patent challenges from Moderna over key components involved in making its COVID-19 vaccine. The court’s decision to side with Canadian biopharmaceutical company Arbutus Biopharma Corporation means Arbutus...
by Jordana Choucair | Dec 2, 2021 | Life Sciences
GlaxoSmithKline PLC and Vir Biotechnology Inc. said their COVID-19 antibody treatment was effective against the omicron variant in early lab tests. The drugmaker said that lab tests of the mutations found in the variant showed the drug is still active against the...
by Jordana Choucair | Dec 1, 2021 | Life Sciences
An advisory panel to the FDA narrowly endorsed Merck & Co. and Ridgeback Biotherapeutics LP’s COVID-19 antiviral pill for patients at high risk of severe illness. The treatment could be available to patients within weeks if the agency authorizes it. In the...
by Jordana Choucair | Nov 30, 2021 | Life Sciences
Pfizer is planning to ask the Food and Drug Administration to approve its COVID-19 booster for 16- and 17-year-olds. According to sources, the agency could authorize extra shots within roughly a week. The request comes as President Biden seeks to reassure the nation...
by Jordana Choucair | Nov 29, 2021 | Life Sciences
A bipartisan group of 61 House members scolded the Biden administration for repealing a rule that would have required Medicare to pay for any medical device deemed as a “breakthrough” by the FDA. The CMS said that although the FDA reviews breakthrough...
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