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.
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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.
BrainStorm Cell Therapeutics announced positive data from a Phase II safety and efficacy study of NurOwn in progressive multiple sclerosis on Oct. 14.
Disappointed over the “lack of clarity” in the U.S. Food and Drug Administration’s stance on potential approval of the company’s proposed chronic kidney disease (CKD) drug, Ardelyx will cut another 102 jobs, according to an SEC Filing.
Before Merck and Acceleron Pharma struck an $11.5 billion merger agreement in September 2021, rare disease-focused Acceleron was wooed by multiple suitors including pharma giant Bristol Myers Squibb, according to a report from Bloomberg.
Europe’s drug regulator started a real-time review of AstraZeneca’s antibody-based Covid-19 therapy, the first protective shot other than vaccines against coronavirus.