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RARE PHOTOS: 44 | Vintage Vibes

A Breast Cancer Drug Approved on July 14 Was Added to National Treatment Guidelines Sixteen Days Later

Gedatolisib was placed in the NCCN breast cancer guidelines as a preferred Category 1 option 16 days after FDA approval. What does that rating mean?

Medical Daily · Jul 31

A Detroit Health System and Michigan State Just Backed Two Medical Technology Startups, and Neither Product Is Cleared for Sale

Henry Ford Health and Michigan State named the first two investments from their $10M health venture fund. What the technologies do and do not do yet.

Medical Daily · Jul 31

FDA Gives Its Most Serious Recall Class to ResMed Astral Ventilators, but Patients Are Told Not to Stop Using Them

FDA assigned a Class 1 recall to ResMed Astral 100 and 150 ventilators. Patients are told not to stop use. Here is the guidance.

Medical Daily · Jul 31

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Vaginal Estrogen Is Linked to Fewer Hospitalizations in Women with Repeat UTIs, and Most Eligible Patients Never Fill the Prescription

New database research links vaginal estrogen to lower sepsis and hospitalization rates in women with recurrent UTIs. What the evidence does and does not show.

Medical Daily · Jul 31

FDA Issues Early Alert on ResMed Astral Ventilators as Replacement Parts Run Short

FDA alerts patients that certain ResMed Astral 100 and 150 ventilators may stop therapy. Parts are limited. What families should do now.

Medical Daily · Jul 31

Two New Studies Show More Women Complete Cervical Cancer Screening When Self-Collection Is Offered

Two new studies found that more women completed cervical cancer screening when offered HPV self-collection. Here is where it is authorized in the US.

Medical Daily · Jul 31

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

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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

Aquafaba Powder Sold as an Egg Replacement Is Recalled Nationwide Because It May Contain Egg

Rooted in Rare Aquafaba Powder, sold as an egg substitute, is recalled nationwide over undeclared egg. Check the UPCs and best-by dates now.

Medical Daily · Jul 31

Parents Told a Toddler Needs Fillings Under Anesthesia Now Have Trial Evidence for a Drill-Free Option

A trial in 830 children under 6 found that 38% of treated baby teeth showed arrested decay, without drilling or sedation.

Medical Daily · Jul 31

Dead People's Skin Is The Latest Anti-Aging Beauty Craze And It Could Soon Come to the US

A controversial anti-aging injectable made from donated human skin is gaining popularity in South Korea and could reach the US market.

Medical Daily · Jul 31

Public Comment Closes on the FDA Plan to Permanently Bar Bulk Compounding of Semaglutide and Tirzepatide

The comment window on FDA's proposal to keep semaglutide and tirzepatide off the 503B bulk list closed July 30. No final decision has been announced.

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

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The Economic Times · 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…

Medical Daily · 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.

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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.

inkl · Jul 31

Why Is Aluminum in Deodorant Bad? What the Concern Really Means

Walk down any personal care aisle and "aluminumfree" jumps off half the boxes. The implication is clear: aluminum is something to avoid. But ask the average shopper why, and the answers range from vague cancer worries to "I just heard it's bad."

Medical Daily · Jul 31

Three Medical Device Categories Established in 2023 Are Now Officially Codified by the FDA

FDA codified three device categories covering a kidney risk test, a diabetes therapy app, and at-home COVID tests. All were classified in 2023.

Medical Daily · Jul 31

FDA Issues an Early Alert on Boston Scientific Carotid Catheters After Reports of Tips Breaking Off

FDA issued an early alert on Boston Scientific ENROUTE carotid catheters after reports of arterial sheath tip separation during use.

Medical Daily · Jul 31

Lancet Results Show Ralinepag Cut Clinical Worsening by 55 Percent in Pulmonary Arterial Hypertension

Published Lancet results show ralinepag reduced clinical worsening in PAH by 55%. The drug is still investigational and not FDA-approved.

Medical Daily · Jul 31

FDA Approves the First Over the Counter Tablet Combining Tylenol and Naproxen for 12 Hour Pain Relief

FDA-approved Tylenol with Naproxen, the first OTC combination of acetaminophen and naproxen sodium, for up to 12 hours of pain relief.

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