The Latest Breaking News from FDA

Rand Paul's Biosimilar Drug Bill Could Cut Costs, Speed Patient Access

The Expedited Access to Biosimilars Act enables FDA approval of pharmaceutically equivalent biologic medications.

Reason · Jul 31

A Second B Cell Drug for IgA Nephropathy Was Approved in July and Two More FDA Decisions Are Due by December

FDA approved atacicept for IgA nephropathy in July. Two more drugs face decisions by year's end. Here is what is proven and what is not.

Medical Daily · Jul 31

FDA Sets a Late-2026 Decision on Adding a PARP Inhibitor to Hormone Therapy for Advanced Prostate Cancer

FDA granted priority review to talazoparib plus enzalutamide for HRR-altered metastatic prostate cancer. A decision is expected in late 2026.

Medical Daily · Jul 31

FDA Updates the Testing Rules for the Blood Tubing Used in Every Hemodialysis Session

FDA issued revised final guidance for hemodialysis blood tubing sets, covering kink resistance, sterility, biocompatibility, and the warnings on every label.

Medical Daily · Jul 31

Bombay HC questions FDA's clean chit to Mantralaya canteens

Mantralaya canteens: The Bombay High Court criticized the Maharashtra FDA for selective enforcement actions. The court noted discrepancies in inspections of government and private eateries. It ordered the FDA to be impartial and uniform in its regulatory drive. The FDA will now re-inspect Mantralaya canteens and issue improvement notices. The…

The Economic Times · Jul 31

FDA Writes Non Medicated Erectile Dysfunction Gels into Federal Regulation with a Fixed Set of Testing Rules

FDA codified a Class II device category for non-medicated topical ED gels, fixing the testing and labeling rules any future product must meet.

Medical Daily · Jul 31

FDA Renamed and Updated Its Companion Diagnostics List, Including the First Test That Detects Cancer's Return in Blood

FDA updated its companion diagnostics list on July 23, adding tests that decide who gets targeted cancer drugs, including a blood-based MRD test.

Medical Daily · Jul 31

FDA Creates a New Device Category for Noise-Canceling Systems Inside Newborn Incubators

FDA formally classified active noise attenuation systems for infant incubators as Class II devices, setting testing and labeling requirements.

Medical Daily · Jul 31

Salmonella Javiana Cases Double to 212 in a Week and the FDA Still Has Not Named a Food

An FDA Salmonella Javiana outbreak doubled to 212 cases in one week. No food has been identified. Here is what that means.

Medical Daily · Jul 31

FDA Advisers Back a Melanoma Treatment for Patients Who Ran Out of Options, and a Decision Is Due Monday

FDA advisers voted 10-3 to back Replimune's RP1 for advanced melanoma after two rejections. The agency's decision is due August 2.

Medical Daily · Jul 31