The U.S. Food and Drug Administration approved Seqirus’ Flucelvax Quadrivalent (Influenza Vaccine), the company’s cell-based quadrivalent influenza vaccine, for an expanded age indication for children as young as 6 months old.
Eisai Co. on Sept. 27 began the application process for the Japanese drugmaker’s experimental drug lecanemab for early Alzheimer’s disease using an accelerated approval pathway, the same path that helped Eisai’s development partner Biogen Inc. win U.S. approval of its medication in June.
Two weeks after winning U.S. approval as a treatment for adults with Waldenstrom’s macroglobulinemia, BeiGene’s Brukinsa scored again as a treatment for adult patients with relapsed or refractory marginal zone lymphoma (MZL).
A study published in the BMJ suggests that about one-third of cancer indications receiving approval under an Accelerated Approval pathway are still on product labels even after follow-up studies did not confirm their benefits.
U.S. health regulators could approve a third Covid-19 shot for adults beginning at least six months after full vaccination, instead of the previously announced eight-month gap, the Wall Street Journal reported on Aug. 25.
Moderna Inc. completed the real-time review process needed for a full approval for the company’s Covid-19 vaccine in people aged 18 years and older.
Formal U.S approval of the Pfizer Inc./BioNTech SE Covid-19 vaccine will make it nearly impossible to successfully challenge mandates by employers, legal experts said.
The United States could get Covid-19 under control by early 2022, with potential wider vaccine approvals coming in the weeks ahead, Dr. Anthony Fauci said one day after Pfizer won wider FDA approval for the company’s novel coronavirus shot on Aug. 23.
The U.S. Food and Drug Administration approved an expanded peripheral artery disease indication for Janssen’s Xarelto (rivaroxaban) vascular dose (2.5 mg twice daily plus aspirin 100 mg once daily) to include patients following recent lower-extremity revascularization due to symptomatic PAD.
New York City will require public school teachers and staff to get vaccinated against Covid-19, Mayor Bill de Blasio said on Aug. 23, part of a push to get more residents inoculated and slow the spread of the highly contagious Delta variant.