CDC recently recommended Johnson & Johnson and Moderna’s COVID-19 vaccine booster shots for all eligible individuals who receive any FDA authorized vaccine.
The organization...
FDA recently granted emergency use authorization to both the Moderna and Johnson & Johnson respective COVID-19 vaccine booster doses.
The agency specifically approved Moderna’s booster...
FDA recently approved Rethymic to treat pediatric patients with rare disease congenital athymia.
Congenital athymia is a rare immune disorder in which a child is born without a thymus. The...
FDA recently awarded 11 new clinical trial research grants, totaling $25 million over the next four years to support the development of medical products for patients with rare diseases.
The...
FDA Vaccines and Related Biological Products Advisory Committee (VRBPAC) recently recommended a booster dose of Moderna’s COVID-19 vaccine, mRNA-1273, at the 50 microgram...
FDA Vaccines and Related Biological Products Advisory Committee (VRBPAC) recently recommended emergency use authorization for a booster dose of Johnson & Johnson’s COVID-19 vaccine.
VRBPAC...
FDA recently granted Roche’s anti-amyloid beta antibody, gantenerumab, breakthrough therapy designation to treat individuals living with Alzheimer’s disease.
The agency based its...
Moderna recently announced that it will build a state-of-the-art mRNA facility in Africa to produce up to 500 million doses of vaccines annually at the 50 microgram dose level.
The company will invest...
FDA recently granted Daiichi Sankyo’s Enhertu breakthrough therapy designation in the US to treat adult patients with unresectable or metastatic HER2-positive breast cancer.
Enhertu is an...
ViiV Healthcare recently announced it made a regulatory submission to FDA for approval of a new dispersible tablet regimen for children living with HIV.
The tablet formulation, Triumeq, includes...
AstraZeneca recently submitted a request to FDA for an emergency use authorization for its long-acting COVID-19 antibody combination, AZD7442.
AstraZeneca optimized AZD7442 using its YTE half-life...
Roche recently announced that Tecentriq elicited disease-free survival in patients with Stage II-IIA non-small cell lung cancer (NSCLC).
Data from the IMpower010 trial, published in The Lancet, found...
Gilead recently announced that a three-day course of its COVID-19 treatment, remdesivir, elicited an 87 percent reduction in risk for the composite primary endpoint of COVID-19-related hospitalization...
FDA recently amended the emergency use authorization for the Pfizer-BioNTech COVID-19 vaccine to allow for a single booster dose six months after completing the primary series.
In December 2020,...
FDA recently granted Breakthrough Designation for Eli Lilly & Company and Boehringer Ingelheim’s diabetes drug, Jardiance, as an investigational treatment for adults with heart failure with...
Roche recently signed a definitive share purchase agreement to acquire 100 percent of the outstanding shares of TIB Molbiol Group to enhance its molecular diagnostic solutions portfolio.
The...
The AMA, American Pharmacists Association (APhA), and American Society of Health-System Pharmacists (ASHP) have called for an “immediate end” to the prescribing, dispensing, and use of...
COVID-19 convalescent plasma given to high-risk outpatients within one week of the onset of coronavirus symptoms does not prevent disease progression, according to a New England Journal of Medicine...
Digital therapeutics present potential solutions for chronic diseases management, ranging from Alzheimer’s disease, type 2 diabetes, congestive heart failure, and cancer. The same technologies...
