FDA Requires Major Changes to Opioid Pain Medication Labeling

The U.S. Food and Drug Administration is requiring safety labeling changes to all opioid pain medications to better emphasize and explain the risks associated with their long-term use.

Argenx Is Conducting a Phase IV Study to Assess Efgartigimod Ph20 SC to Treat Adult CIDP Patients

Argenx is conducting a Phase IV clinical study to evaluate how adults with chronic inflammatory demyelinating polyneuropathy transition from intravenous immune globulin treatment to efgartigimod PH20 SC.

HHS Cuts Funding for mRNA Vaccine Research

The U.S. Department of Health and Human Services (HHS) has begun a coordinated wind-down of its mRNA vaccine development activities under the Biomedical Advanced Research and Development Authority (BARDA).

FDA Fast Tracks Immunotherapy for HER2-Positive Breast Cancer Recurrence

The U.S. Food and Drug Administration has granted fast track designation for Greenwich LifeSciences’ lead immunotherapy candidate GLSI-100 in HLA-A*02–positive, HER2-positive breast cancer patients who have completed standard HER2-targeted therapy.

IVIG Reduces Infections Following BsAB Therapies in Multiple Myeloma Patients

A recent study showed treatment with intravenous immune globulin following infection from BCMA therapies yielded a 67 percent decrease in infections in patients with multiple myeloma.

FDA Approves Merck’s KEYTRUDA QLEX for Solid Tumor Indications

The U.S. Food and Drug Administration has approved KEYTRUDA QLEX (pembrolizumab and berahyaluronidase alfa-pmph) injection for subcutaneous administration in adults across most solid tumor indications for KEYTRUDA (pembrolizumab).

States Issue Their Own Guidance About COVID-19 Vaccines

Since the U.S. Food and Drug Administration released its 2025-2026 formula approvals on Aug. 2, significantly restricting who can access the vaccines for the first time since their release, several states have issued their own guidance about COVID-19 vaccines.

Study Shows Pfizer’s Updated mRNA COVID-19 Vaccine Elicits Strong Immune Response

Pfizer and BioNTech updated mRNA COVID-19 vaccine for the 2025-2026 season produced strong immune responses, boosting neutralizing antibody levels by at least fourfold in older people and those with underlying medical conditions.

Merck’s Pneumococcal Vaccine Elicits Immune Responses to 21 Serotypes in Children with one or More Health Conditions

Positive results from Merck’s Phase III STRIDE-13 trial for its Capvaxive vaccine, a pneumococcal 21-valent conjugate vaccine show it has the potential to provide additional protection in individuals 2 through 17 years old.

FDA Expands Approval for Recombinant VWF

The U.S. Food and Drug Administration has expanded the approval of recombinant von Willebrand factor, marketed as Vonvendi.