Datroway Gains Lung Cancer Indication

On June 23, 2025, the US Food and Drug Administration (FDA) granted accelerated approval to Daiichi Sankyo and AstraZeneca’s Datroway^® (datopotamab deruxtecan-dlnk) for adults with locally advanced or metastatic epidermal growth factor receptor (EGFR)-mutated non-small cell lung cancer (NSCLC) who have received prior EGFR-directed therapy and platinum-based chemotherapy. This approval is based on pooled data from the TROPION-Lung05 and TROPION-Lung01 trials, showing a 45% overall response rate (ORR) and a median duration of response (DOR) of 6.5 months. Initially approved in January of 2025 for breast cancer, Datroway is a specifically engineered TROP-2 directed antibody and topoisomerase inhibitor conjugate. The recommended dose is 6mg/kg given as an intravenous (IV) infusion once every three weeks until disease progression or unacceptable toxicity. The FDA granted Datroway Accelerated Approval, which means that further results confirming its effectiveness and safety will be required before the FDA gives it full approval. Updated prescribing information can be found here.

Subcutaneous Benlysta Gets New Indication for Pediatric Lupus Nephritis

The FDA approved an autoinjector for the subcutaneously (SC) administered formulation of GSK’s Benlysta^® (belimumab) for use in patients aged five years and older with active lupus nephritis (LN) receiving standard therapy on June 24, 2025. The IV formulation of GSK’s B-lymphocyte stimulator (BLyS)-specific inhibiting monoclonal antibody has been approved to treat LN for children in the same age group since July 2022, but the infusions must be administered by a healthcare professional – usually in a healthcare facility. The SC version was approved for pediatric patients with active systemic lupus erythematosus (SLE) in 2024. Lupus nephritis is a serious complication of lupus where the immune system mistakenly attacks the kidneys, causing inflammation and potential damage. Around 30-50% of children with lupus develop this condition, usually within one to two years of being diagnosed with lupus. This approval provides the first at-home treatment option for pediatric LN, reducing the burden of frequent clinic visits. Full prescribing information is available here.

Illuccix Gets Label Expansion

Telix Pharmaceuticals announced on June 24, 2025, that the FDA approved a label expansion for the imaging prostate cancer agent Illuccix^® (kit for the preparation of gallium Ga-68 gozetotide for injection). The prostate-specific membrane antigen (PSMA) is radiolabeled with gallium-68 (68Ga) gozetotide before a positron emission tomography (PET) imaging procedure. The PSMA-directed therapy, as described in the Prescribing Information of the therapeutic products indication, now includes patient selection for radioligand therapy (RLT) in the pre-taxane setting. This update allows for the selection of patients indicated for PSMA-directed therapy before chemotherapy and is expected to increase utilization by about 20,000 scans annually. Like all radioactive pharmaceuticals, Illuccix is handled under precise conditions by imaging centers, hospitals and nuclear pharmacies that have specifically trained staff, specialized equipment and strict protocols for using and discarding radioactive substances. Complete prescribing information is here.

First Ablysinol Generic

On June 24, 2025, Breckenridge Pharmaceutical announced that the FDA approved its dehydrated alcohol injection, USP, 5mL of ≥ 99% by volume ethyl alcohol single-dose vials, the first generic to Ablysinol^® by Belcher Pharmaceuticals. Dehydrated alcohol injection is a sterile, preservative-free solution of ≥99% ethyl alcohol, meeting USP standards. It is indicated for inducing controlled cardiac septal infarction to improve exercise capacity in adults with symptomatic hypertrophic obstructive cardiomyopathy (HOCM) who are not suitable for surgical myectomy. The prescribing information will be available in the Drugs@FDA drug database at www.fda.gov.

Endari Labeling Updates

Emmaus Life Sciences announced FDA approval on June 26, 2025, for updated labeling of Endari^® (L-glutamine oral powder) based on post-marketing pharmacokinetic study data. The new labeling includes study information on body weight dosing, confirmation that there is no unwanted accumulation with twice daily dosing, and that administration can be with or without food. Endari is approved to reduce acute complications of sickle cell disease in patients aged five years and older. The updated prescribing information can be found here.

FDA Expands Amyvid Label 

On June 25, 2025, Eli Lilly announced that the FDA approved a label update for Amyvid^® (florbetapir F 18 injection) for IV use. Amyvid, a radioactive diagnostic drug, is now indicated for brain imaging to estimate amyloid plaque density in patients with cognitive impairment being evaluated for Alzheimer’s disease and other cognitive declines and for selecting patients for amyloid-targeting therapy. The updated label allows the quantification of amyloid plaque levels alongside visual interpretation. Initially approved in 2012, Amyvid is administered via PET scan, providing a diagnostic tool for confirming amyloid plaque presence. The recommended use includes careful interpretation by trained radiologists. Here is the updated prescribing information.

MedWatch Update

FDA Updates Warning Label of mRNA COVID-19 Vaccines

On June 25, 2025, the FDA released a new safety communication requiring updating prescribing information for  Comirnaty^® (COVID-19 Vaccine, mRNA – Pfizer) and Spikevax^® (COVID-19 Vaccine, mRNA – Moderna) to include new information about the risks of myocarditis and pericarditis. Although labeling has included information about myocarditis (inflammation of the heart muscle) and pericarditis (inflammation of the lining outside of the heart) since 2021, the labeling now reflects that the observed risk following vaccination has been the highest in males aged 12 through 24 years. The Fact Sheets for healthcare providers and recipients have also been updated accordingly. Continuous safety monitoring is ongoing, and manufacturers are required to study long-term heart effects in those diagnosed with myocarditis post-vaccination. The FDA Safety Communication may be found here. 

Recall

Swabflush Prefilled Syringes with SwabCaps Recalled

On June 18, 2025, Medline Industries, LP issued a recall for specific lots of SwabFlush^™ Prefilled Syringes with ICU Medical SwabCaps^™. The issue involves an incomplete seal between the foil lid and the plastic container of the SwabCap, resulting from a manufacturing defect. This defect may lead to the evaporation of the isopropyl alcohol on the sponge, resulting in a reduced level of disinfection of the luer access valve and potentially causing patient infection or sepsis. The SwabFlush Prefilled Syringe is used for flushing and locking vascular access devices to maintain patency and prevent infection. For further information on the recall, see here.

Device Correction for Dexcom

On May 12, 2025, Dexcom issued an Urgent Medical Device Correction for Dexcom G6 and G7 receivers. On June 16, 2025, the FDA updated it to a Class I recall. Receivers may fail to deliver the expected audible alarms, potentially leading to delayed or missed detection of severe hypoglycemia or hyperglycemia. Dexcom is encouraging users to check their serial numbers here and then contact Dexcom at 844.478.1600 if they are impacted for replacement. Dexcom G6 and G7 receivers are part of a continuous glucose monitoring (CGM) system that can help monitor blood glucose levels in patients with diabetes. For more information on the recall, see here.