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.
Category: US Pharmaceuticals
US Pharmaceuticals
Latest
US Pharmaceuticals
Latest
FDA Authorizes Monoclonal Antibodies for COVID-19
The FDA authorized Eli Lilly and Co's bamlanivimab and etesevimab, monoclonal antibodies for the treatment of mild to moderate COVID-19.
US Pharmaceuticals
Popular
FDA Approves Nucala for Eosinophilic Granulomatosis with Polyangiitis
The FDA has approved Nucala (mepolizumab) as the first targeted treatment for eosinophilic granulomatosis with polyangiitis (EGPA), previously known as Churg-Strauss syndrome.
Clinical Trials Testing Two Monoclonal Antibodies for COVID-19
A Phase 2/3 clinical trial has begun to evaluate a combination investigational monoclonal antibody therapy used for COVID-19.
Read More
Antidepressant Fluvoxamine May Reduce Severity of COVID-19
A 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 More
Pfizer Vaccine Effective Against COVID-19 Variants, in vitro Studies Find
The 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 More
FDA: Administer COVID-19 Vaccines as Directed
The 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 More
Health Officials Consider Splitting or Cutting COVID-19 Vaccines to Inoculate More Americans
Healthcare 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 More
Moderna Increases Vaccine Production Forecast to 600M Doses in 2021
Roughly 20% more doses of Moderna’s COVID-19 vaccine will be produced in 2021, a minimum of 600 million.
Read More
Novavax COVID-19 Vaccine Enters Ph3 Trials
The Novavax vaccine is the fifth COVID-19 vaccine candidate to begin clinical trials, after Pfizer/BioNTech, Moderna, AstraZeneca, and Johnson & Johnson.
Read More
aTyr Pharma Begins Phase 1b/2a Clinical Trial for Sarcoidosis Drug
aTyr Pharma Inc has completed the target enrollment in its Phase 1b/2a clinical trial for ATYR1923 in patients with pulmonary sarcoidosis.
Read More
Moderna COVID-19 Vaccine Authorized, May Begin Innoculations Monday
According 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 More
FDA Approves Tagrisso for NSC Lung Cancer
The 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 More
FDA Approves Xolair for Nasal Polyps
Xolair is now FDA-approved across three diseases, including persistent allergic asthma, chronic idiopathic urticaria, and now nasal polyps.
Read More
FDA Expected to Authorize Moderna COVID-19 Vaccine as Early as Friday
The 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.
Read More