FDA Updates

This marks the first FDA-approved treatment for this rare lipid storage disease.

67Cu-SAR-bisPSMA is indicated for adult patients with prostate-specific membrane antigen (PSMA)-positive metastatic castration-resistant prostate cancer (mCRPC).

Priority review status will allow for expedited development of zongertinib, putting it on the path toward approval as the first in a new class of drugs for mutated NSCLC.

The approval in multiple indications is designed to improve access to effective, proven treatments for skeletal fractures, which can greatly reduce patient quality of life.

Invasive meningococcal disease is a severe bacterial infection caused by the bacterium Neisseria meningitidis, often leading to meningitis or sepsis.

Amlenetug could provide a treatment option for patients with multiple system atrophy, a progressive and rare condition that causes damage to the brain’s nerve cells.

Insulin-aspart-szjj (Merilog) is the first rapid-acting insulin biosimilar product approved by the FDA.

The indication is for symptomatic tenosynovial giant cell tumor (TGCT) for which surgical resection will potentially cause worsening functional limitation or severe morbidity.

PP-01 could become a first-in-class treatment for patients with cannabis use disorder.

The agency will now review the novel PCSK9 inhibitor for possible approval in patients with or at high risk of atherosclerotic cardiovascular disease.

Building on a previously granted orphan drug designation, the latest FDA action for amezalpat puts the drug in a position for regulatory approval.

Avacincaptad pegol intravitreal solution is a prescription eye injection used to treat geographic atrophy.

Risdiplam is the only approved non-invasive disease-modifying SMA treatment.

The approval follows the ECHELON-3 study, which enrolled adults with relapsed or refractory large B-cell lymphoma.

The approval is based on positive clinical trial results that indicated deep and durable reductions in plexiform neurofibroma.

Rezpegaldesleukin is designed to balance the body’s immune system response through activation of regulatory T-cells.

If approved, brensocatib will be the first and only approved treatment for bronchiectasis and the first within a new class of medicines, called dipeptidyl peptidase 1 inhibitors.

BR55, an injection of perfluorobutane/nitrogen lipopeptide-coated microbubbles, could aid in the detection of angiogenesis and allow for earlier diagnosis in patients with Crohn disease.

The indication is for patients with endometrial cancer who may benefit from treatment with ACR-368 (Acrivon Therapeutics).

The decision offers patients with antimicrobial resistance, who have limited or no treatment options, a new alternative.

The designation builds on previous regulatory action for ADI-001 and allows for expedited development of the treatment for systemic lupus erythematosus.

ABO-101 is supported by preclinical data that demonstrated significant reductions in urinary oxalate in PH1 disease models.

Diabetic macular edema (DME) is the leading cause of new blindness in the US.

The approval marks the first subcutaneous infusion device approved for the treatment of Parkinson disease, providing a new option for patients with serious disease who are unresponsive to other therapies.

Tocilizumab-anoh is expected to increase competition, improve patient access, and deliver cost savings in the treatment of various inflammatory conditions.

The regenerative medicine advanced therapy designation expedites the development and review of regenerative medications that have the potential to address unmet needs for serious or life-threatening diseases.

The approval includes indications for rheumatoid arthritis, giant cell arteritis, polyarticular juvenile idiopathic arthritis, systemic juvenile idiopathic arthritis, and COVID-19.

Meloxicam and rizatriptan reduces migraine pain and help patients return to normal functioning with efficacy through 24 to 48 hours after a single dose for some patients.