FDA Updates

Mounjaro becomes the first GIP/GLP-1 receptor agonist cleared to lower MACE risk, based on the SURPASS-CVOT head-to-head trial.

The updated formula targets the JN. 1-lineage XFG variant and begins shipping immediately to pharmacies, hospitals, and clinics nationwide.

Brepocitinib (Lisraya), a once-daily TYK2-JAK1 inhibitor, is the first oral therapy approved for adults with the rare autoimmune disease.

Early-phase trial data showed antitumor activity in heavily pretreated metastatic colorectal cancer.

If confirmed, the FDA nominee's views on abortion pills, vaccines, and drug review could reshape pharmacists' daily work.

CK0803 is an investigational allogeneic cord blood–derived regulatory T-cell therapy designed to target neuroinflammation in amyotrophic lateral sclerosis.

Daraxonrasib, an oral RAS inhibitor, was approved for adults with metastatic pancreatic adenocarcinoma after prior systemic therapy or when multiagent systemic therapy is not appropriate.

The FDA has expanded the approval of dolutegravir expands access to a second-generation integrase inhibitor for infants in the neonatal period.

Abbott's Libre Duo 10 Day tracks both glucose and ketones to flag rising DKA risk in people with diabetes 2 years and older.

The first single-biomarker blood test is cleared for both rule-in and rule-out of amyloid pathology in primary and specialty care.

Nipocalimab is the first therapy approved specifically for wAIHA, a rare, life-threatening autoantibody disease driving red blood cell destruction.

The FDA has granted fast track designation to ERAS-0015, an investigational oral pan-RAS molecular glue that has shown early antitumor activity in previously treated KRAS G12X pancreatic ductal adenocarcinoma.

The FDA-granted priority review raises the possibility of an immunotherapy-first approach that could allow some patients to avoid chemotherapy, radiation, and surgery.

The FDA granted fast track designation to safusidenib, an investigational oral IDH1 inhibitor that produced durable responses in a phase 2 study of patients with treatment-naive grade 2 IDH1-mutant glioma.

Cardiomyopathy, hepatitis B, breast cancer, hypertension, and myeloma decisions land in the FDA's final-quarter queue.

Its targeted PDE4 mechanism, favorable safety profile, and supportive pediatric data make it a meaningful long-term treatment addition.

Genglycos wins accelerated approval to cut daily cornstarch reliance in patients aged 8 and older with the rare metabolic disorder.

Garetosmab-grts cut new heterotopic ossification lesions by 90% or more at 56 weeks in the phase 3 OPTIMA trial.

The agency's decision pairs a new self-administration device with label language tying LDL-C lowering to cardiovascular outcomes.

The designation highlights an emerging strategy targeting TNFR2-mediated immune suppression in heavily pretreated platinum-resistant ovarian cancer.

The newly available OTC combination pairs dextromethorphan, guaifenesin, and naproxen sodium in a 12-hour formulation, creating new opportunities for pharmacist counseling on NSAID risks and duplicate therapy.

The therapy is administered via an intratumoral injection every 2 weeks for 8 consecutive doses.

The approval clears the way for a new vaccine option for older adults ahead of the 2026 to 2027 flu season.

Orzeyful is the first orexin-restoring therapy for NT1, backed by the phase 3 FirstLight and RadiantLight trials.

The FDA’s expanded approval of lutetium Lu 177 vipivotide tetraxetan introduces PSMA-targeted radioligand therapy to mHSPC.

This roundup highlights 5 key solid tumor updates from July 2026, including new FDA approvals across bladder, breast, and lung cancers, a tissue-agnostic targeted therapy, and a blood-based colorectal cancer screening test.

An FDA advisory vote boosts access hopes for peptide supporters, but compounding remains illegal pending rulemaking.

The FDA approved SimpleScreen CRC, a blood-based screening test for average-risk adults aged 45 and older, potentially expanding screening access.