Advisers to the U.S. Food and Drug Administration voted on Sept. 17 to recommend Covid-19 vaccine booster shots for Americans 65 and older and those at high risk of severe illness, after overwhelmingly rejecting a call for broader approval.

The U.S. Food and Drug Administration approved Takeda Pharmaceutical Company Limited’s Exkivity (mobocertinib) for the treatment of adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) exon 20 insertion mutations as detected by an FDA-approved test, whose disease has progressed on or after platinum-based chemotherapy.

Pfizer BioNTech, COVID booster

U.S. Food and Drug Administration scientists said on Sept. 15 that booster doses of Pfizer’s Covid-19 vaccine may not be needed, even though the third shot generates a higher immune response in recipients.

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.

Additional Covid-19 vaccine booster shots are not needed for the general population, leading scientists including two departing senior U.S. Food and Drug Administration officials and several from the World Health Organization (WHO) said in an article published in a medical journal on Sept. 13.

The U.S. Food and Drug Administration accepted for review a Biologics License Application (BLA) for the anti-PD-1 antibody tislelizumab as a treatment for patients with unresectable recurrent locally advanced or metastatic esophageal squamous cell carcinoma (ESCC) after prior systemic therapy.

The U.S. Food and Drug Administration said on Sept. 10 clinical trials testing Covid-19 vaccines for children are expected to include a monitoring period of at least two months after half the participants get the shots to ensure safety.

The U.S. Food and Drug Administration said on Sept. 9 the regulatory agency needs more time to decide whether e-cigarette maker Juul Labs Inc. and other major manufacturers can sell their products in the United States.

Shares of Humanigen plunged in trading after the company announced the U.S. Food and Drug Administration rejected the company’s Emergency Use Authorization request for lenzilumab, a potential treatment for Covid-19.