(Reuters) -The U.S. health regulator is delaying its decision on authorizing Moderna Inc’s COVID-19 vaccine for adolescents to check if […]
FDA takes new action to improve quality and efficacy of sunscreens
As part of its ongoing implementation of new authorities for certain over-the-counter (OTC) drugs, the U.S. Food and Drug Administration […]
FDA clears investigational drug for ALS gene therapy trials
Apic Bio, a gene therapy company developing treatment options for patients with rare genetic diseases and co-founded by UMass Medical […]
FDA Okays New Indication for Alirocumab in Homozygous FH
The US Food and Drug Administration has approved alirocumab (Praluent, Regeneron Pharmaceuticals) injection as add-on therapy for adults with homozygous familial […]
FDA Okays New Indication for Alirocumab in Homozygous FH
The US Food and Drug Administration has approved alirocumab (Praluent, Regeneron Pharmaceuticals) injection as add-on therapy for adults with homozygous familial […]
Adalimumab Earns FDA Approval for Ulcerative Colitis in Children
Adalimumab has received approval from the Food and Drug Administration for use in pediatric patients aged 5 years and older […]
J&J asks FDA to authorize its ONE-DOSE COVID019 vaccine
Johnson & Johnson asks the FDA to authorize its ONE-SHOT coronavirus vaccine that prevents 100% of COVID-19 hospitalizations and deaths […]
South African coronavirus variant may ‘obviate’ antibody drugs, former FDA head says
Fox News Flash top headlines for January 6 Fox News Flash top headlines are here. Check out what’s clicking on […]
AstraZeneca could ask for FDA approval of its shot by February
AstraZeneca could ask the FDA to approve its coronavirus vaccine as early as February, Operation Warp Speed chief says AstraZeneca’s […]
US FDA nod may give Pfizer’s approval case in India a boost
The recommendation by an advisory panel of the US Food and Drug Administration (FDA) that the regulator provide emergency use […]