Convalescent plasma from patients who have recovered from COVID-19 reduced hospitalizations by nearly 50% for outpatients infected with the virus in a nationwide, multicenter clinical trial.
Johns...
FDA recently granted emergency use authorization for Siemens Healthineers’ CLINITEST Rapid COVID-19 Antigen Self-Test.
The nasal swab test is a point-of-care cassette test that does not require...
Life Science Biosensor Diagnostics (LSBD), a subsidiary of the iQ Group Global, recently filed an FDA Breakthrough Device Designation application for its Saliva Glucose Biosensor for diabetes care...
FDA recently expanded the emergency use authorization for the Pfizer-BioNTech COVID-19 vaccine booster to include individuals 12 years of age and older.
The authorization follows two months after the...
FDA recently granted emergency use authorization to Roche’s COVID-19 At-Home Test for children aged 14 years and older and by an adult for children aged two to 13 years.
The COVID-19 At-Home...
FDA recently sent a warning letter to Medtronic for the headquarters facility of its diabetes business in Northridge, California.
The warning letter focused on the inadequacy of specific medical...
FDA recently issued an emergency use authorization for Merck’s COVID-19 treatment, molnupiravir, for adults 18 years of age and older.
The agency authorized the treatment for adults with high...
AstraZeneca recently entered into a global development and commercialization agreement with Ionis Pharmaceuticals for transthyretin amyloidosis medication, eplontersen.
Eplontersen is a...
FDA is working with federal partners and regulators to address potential impacts of the new Omicron variant and urges everyone to receive COVID-19 vaccinations or booster shots, according to an...
CDC Director Rochelle Walensky, MD, MPH, recently endorsed the CDC Advisory Committee on Immunization and Practices’ (ACIP’s) recommendation for COVID-19 vaccine booster shots to include...
FDA recently granted breakthrough device designation for Datar Cancer Genetics’ blood test to detect early-stage breast cancer.
The test, TriNetra, uses proprietary technology to detect...
FDA recently expanded the emergency use authorization (EUA) for a booster dose of the Pfizer-BioNTech COVID-19 vaccine to include individuals 18 years of age and older.
Caregivers can administer the...
FDA recently approved PharmaEssentia’s injection to treat adults with polycythemia vera, a rare blood disease that causes overproduction of red blood cells.
The monopegylated, long-acting...
President Joe Biden recently nominated Robert Califf as head of FDA, according to multiple news sources.
Califf previously served as FDA commissioner at the end of the Obama administration from 2016...
The US government recently purchased additional doses of Eli Lilly and Company’s combination COVID-19 antibody treatment.
Under the agreement, Eli Lilly and Company will supply 614,000 doses of...
FDA recently granted emergency use authorization to Thermo Fisher Scientific to run new saliva sample collection methods on its COVID-19 tests.
The company’s molecular diagnostics Spectrum...
FDA recently granted emergency use authorization to Pfizer and BioNTech’s COVID-19 vaccine for children five through 11 years of age.
The agency based its decision on data from a Phase 2/3...
The National Institutes of Health (NIH), FDA, ten pharmaceutical companies, and five non-profit organizations recently partnered to boost the development of gene therapies for 30 million Americans...
FDA recently accepted Novartis’ biologics license application for Beovu, the company’s diabetic macular edema (DME) drug.
Specifically, FDA accepted the application for six...
FDA recently approved Eli Lilly and Company’s Verzenio to treat adult patients with hormone receptor-positive (HR+), human epidermal growth factor receptor 2-negative (HER2-), early breast...
