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Outside advisers to the U.S. Food and Drug Administration on Oct. 15 voted unanimously to recommend regulators authorize a second shot of Johnson & Johnson’s Covid-19 vaccine to better protect Americans who received the one-dose vaccine.
The FDA’s outside expert panel will meet on November 30, 2021, to deliberate Merck’s pill for Covid-19 infection.
Facing thousands of lawsuits related to Johnson & Johnson’s talc-based products, the life sciences giant is launching a separate subsidiary dubbed LTL Management LLC that will take the brunt of potential legal liabilities.
The U.S. Food and Drug Administration agreed to place Regeneron Pharmaceuticals Inc.’s Biologics License Application (BLA) for the Covid-19 drug REGEN-COV under priority review with a target action date of April 13, 2022.
The U.S. Food and Drug Administration approved Seqirus’ Flucelvax Quadrivalent (Influenza Vaccine), the company’s cell-based quadrivalent influenza vaccine, for an expanded age indication for children as young as 6 months old.
AstraZeneca announced positive high-level data from the HIMALAYA Phase III trial of a single, high priming dose of tremelimumab plus Imfinzi (durvalumab) in patients with unresectable hepatocellular carcinoma (HCC), or liver cancer, who had not had previous systemic therapy and were not eligible for localized treatment.
Bayer terminated a vaccine manufacturing partnership under which the company would have helped produce CureVac’s Covid-19 shot, a spokesperson for Bayer told a German newspaper.
A panel of expert advisers to the U.S. Food and Drug Administration unanimously voted on Oct. 14 to recommend booster shots of Moderna Inc.’s Covid-19 vaccine for Americans aged 65 and older and those at high risk of severe illness or occupational exposure to the virus.
A unit of Abbott Laboratories is recalling two Covid-19 laboratory test kits as they can potentially issue false positive results, the U.S. Food and Drug Administration said on Oct. 14.
Four leading pharmaceutical companies partnered with Amazon Web Services and Israel Biotech Fund to launch AION Labs, an innovative space that will allow drug developers to harness artificial intelligence technologies and computational science to solve therapeutic challenges.