The FDA announced guidance Thursday that allows manufacturers and distributors of dietary supplements to submit late new dietary ingredient (NDI) notifications if they have failed to do so. Directors...
FDA recently lifted the clinical hold on Gilead’s investigational new drug application (IND) to evaluate injectable lenacapavir for HIV treatment and HIV pre-exposure prophylaxis...
Bristol Myers Squibb and Nektar Therapeutics recently ended the global clinical development program for their combination drug therapy, bempegaldesleukin (BEMPEG) and Opdivo (nivolumab), in renal cell...
The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) recently issued positive opinion of Johnson & Johnson’s COVID-19 vaccine booster for...
A federal jury recently held CVS, Walgreens, and Walmart pharmacies accountable for their role in an opioid crisis in two Ohio counties, according to a report from the Associated Press.
Between 2012...
Pfizer and BioNTech recently announced that two doses of their COVID-19 vaccine elicited neutralizing antibody responses in pediatric patients in a Phase 2/3 clinical trial.
In the trial,...
Novartis recently announced that the Phase 3 clinical trial investigating its aggressive B-cell-non-Hodgkin lymphoma (NHL) treatment, Kymriah, did not meet its primary endpoint of event-free survival...
AstraZeneca recently announced that its COVID-19 antibody combination, AZD442, reduced the risk of symptomatic coronavirus by 77 percent compared to placebo in a Phase 3 trial.
The randomized,...
The Department of Defense (DoD) recently awarded a $6 million technology and therapeutic development award to the University of Illinois (UIC) to test a COVID-19 drug candidate.
UIC will use the...
Biogen recently announced that its Alzheimer’s disease drug, BIIB080, was safe and well-tolerated in patients with mild disease. The drug was developed in partnership with Ionis...
Pfizer and Valneva recently completed recruitment for the Phase 2 clinical trial of Lyme disease vaccine candidate, VLA15.
The trial, VLA15-221, builds on previous positive Phase 2 trials and...
Johnson & Johnson recently announced that its COVID-19 vaccine elicited strong antibody and T-cell immune responses as long as eight months after vaccination.
The results, published in the New...
FDA recently updated the label on Johnson & Johnson’s COVID-19 vaccine to warn of the possible side effect of Guillain-Barre syndrome, according to multiple news outlets.
Of the 100...
AstraZeneca recently announced that its long-acting antibody, nirsevimab, demonstrated positive safety and tolerability profile in infants at high risk of respiratory syncytial virus (RSV) in a Phase...
Kite recently announced that its CAR T-cell therapy, Yescarta, improved event-free survival by 60 percent compared to the standard of care in a Phase 3 clinical trial.
After a median follow-up of two...
The Assistant Secretary for Preparedness and Response (ASPR) recently paused all distribution of Eli Lilly and Company’s COVID-19 antibody treatment.
CDC identified that the combined frequencies...
FDA recently updated its letter of authorization for Johnson & Johnson’s COVID-19 vaccine to help facilitate potential export to other countries.
Under the revised letter, FDA...
Abbott recently announced that it received CE Mark for its latest-generation transcatheter aortic valve implantation (TAVI) system, Navitor, for individuals with severe aortic stenosis in...
Merck recently announced that its anti-PD-1 therapy, Keytruda significantly helped patients with high-risk early-stage triple-negative breast cancer (TNBC)
The Phase 3 KEYNOTE-522 trial investigated...
