FDA to Review Expanded Application of Dupixent for Childhood Asthma
The FDA will review an sBLA for Dupixent (dupilumab) as an add-on treatment for children aged 6 to 11 years with uncontrolled moderate-to-severe asthma.
The FDA will review an sBLA for Dupixent (dupilumab) as an add-on treatment for children aged 6 to 11 years with uncontrolled moderate-to-severe asthma.
The FDA authorized Eli Lilly and Co's bamlanivimab and etesevimab, monoclonal antibodies for the treatment of mild to moderate COVID-19.
The FDA has approved Nucala (mepolizumab) as the first targeted treatment for eosinophilic granulomatosis with polyangiitis (EGPA), previously known as Churg-Strauss syndrome.
A Phase 2/3 clinical trial has begun to evaluate a combination investigational monoclonal antibody therapy used for COVID-19.
Read MoreA COVID-19 clinical trial will test the effectiveness of fluvoxamine, an antidepressant currently used to treat obsessive-compulsive disorder, social anxiety disorder, and depression.
Read MoreThe antibodies from people who have received the Pfizer BioNTech COVID-19 vaccine effectively neutralize SARS-CoV-2 with a key mutation that is also found in two highly transmissible strains.
Read MoreThe US FDA warned healthcare providers to administer the COVID-19 vaccines from Moderna and Pfizer as authorized, not to halve doses or delay second shots.
Read MoreHealthcare officials are weighing whether to delay the second doses of the COVID-19 vaccine or to halve the recommended dose in order to reach more people.
Read MoreRoughly 20% more doses of Moderna’s COVID-19 vaccine will be produced in 2021, a minimum of 600 million.
Read MoreThe Novavax vaccine is the fifth COVID-19 vaccine candidate to begin clinical trials, after Pfizer/BioNTech, Moderna, AstraZeneca, and Johnson & Johnson.
Read MoreaTyr Pharma Inc has completed the target enrollment in its Phase 1b/2a clinical trial for ATYR1923 in patients with pulmonary sarcoidosis.
Read MoreAccording to CNN, the Moderna rollout is four times larger than Pfizer’s and doses could be administered to healthcare workers as early as today (Dec 21).
Read MoreThe US FDA just approved AstraZeneca’s Tagrisso (osimertinib) as the first adjuvant treatment for patients with non-small cell lung cancer whose tumors have a specific type of genetic mutation.
Read MoreXolair is now FDA-approved across three diseases, including persistent allergic asthma, chronic idiopathic urticaria, and now nasal polyps.
Read MoreThe Moderna COVID-19 vaccine was recommended for approval by an FDA advisory panel on Thursday and would be the second vaccine to receive emergency authorization.
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