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The CDC just pulled the biggest lever in its emergency toolkit. On Friday, the agency raised its Ebola response to Level 1 — the highest internal alert — as the outbreak ravaging the Democratic Republic of Congo and Uganda shows no signs of slowing. More than 1,100 people have tested positive since May, and at least 250 have died, though officials concede the real number is likely far higher since the virus spread undetected for months. "We are very concerned about the...
The FDA has approved Viridian Therapeutics' veligrotug, branded as Lumvoa, for thyroid eye disease — ending Amgen's Tepezza's solo run as the only approved therapy since 2020. Thyroid eye disease, an autoimmune condition causing painful eye bulging, double vision, and potential vision loss, has been a one-drug monopoly. CEO Steve Mahoney said Lumvoa will be priced "in line with" Tepezza, setting up a direct head-to-head pricing battle from day one. For...
Only 0.04% of people face a 10% or higher risk of serious statin-related muscle disorders over a decade. That's the headline from a massive new study published Thursday in The Lancet Digital Health, which analyzed medical records from nearly 6 million adults in the United Kingdom. For context, previous American Heart Association estimates pegged the rate of statin-related myopathy at under 1% and rhabdomyolysis — the dangerous breakdown of muscle tissue —...
The FDA's compounding advisory committee will meet July 23-24 to debate whether to ease restrictions on seven injectable peptides — including BPC-157, Semax, and TB-500 — that currently thrive in a gray market fueled by social media influencers and wellness enthusiasts. The problem? Evidence of safety and efficacy in humans ranges from "thin to nonexistent." Dr. Eric Topol, director of the Scripps Research Translational Institute, was blunt: "The ban is...
Recent developments in health and medical science highlight significant advancements in cancer treatment, strategic shifts in the biotech industry, and the growing role of AI in healthcare.
The FDA has granted two new indications for sacituzumab govitecan (Trodelvy) in metastatic triple-negative breast cancer. In another promising cancer breakthrough, an existing FDA-approved drug, AMD3100, has been found to significantly improve the effectiveness of immunotherapy against rare liver cancer by...
The FDA just fired a double-barreled response to breast cancer. On back-to-back days, the agency approved Pfizer's palbociclib (Ibrance) as a first-line maintenance treatment for HR-positive/HER2-positive metastatic breast cancer — the first CDK4/6 inhibitor with that indication regardless of HER2 status — and cleared Gilead's Trodelvy for two new first-line uses in triple-negative breast cancer. The PATINA trial showed patients on palbociclib went **44.3...
The Bundibugyo ebolavirus outbreak tearing through Central Africa is about to meet its first real test: a clinical trial launching next week in the Democratic Republic of Congo will test Gilead Sciences' remdesivir and MappBio's monoclonal antibody MBP-134 against a strain that has no approved treatments or vaccines.
Key numbers from the front lines:
| Metric | DRC | Uganda |
|---|---|---|
| Confirmed cases | 1,118 | 20 |
| ... |
The weight loss drug revolution just got a price tag that actually makes sense. HHS has announced the Medicare GLP-1 Bridge pilot program, starting July 1 and running through December 31, 2027, that caps the cost of Wegovy, Foundayo, and Zepbound KwikPens at $50 per month for eligible Medicare Part D enrollees. An estimated 14 million recipients could qualify — representing the federal government's boldest move yet to make these blockbuster drugs...
HHS unveiled a blueprint Monday to fast-track early-stage drug trials in the US, aiming to shave 6 to 12 months off development timelines — and the unsubtle target is China. The plan pairs drug sponsors with research institutions to streamline Investigational New Drug applications, cutting unnecessary toxicology and manufacturing documentation. Acting FDA Commissioner Kyle Diamantas told reporters the agency will also affirm that a single, high-quality Phase 3...
A single 79-year-old mystery patient got special access to Eli Lilly's experimental obesity drug retatrutide — and the White House won't say it wasn't President Trump. STAT broke the story Tuesday: a senior NIH clinician, Ranganath Muniyappa, requested the drug in April for a patient with refractory obesity, obstructive sleep apnea, and pulmonary hypertension. The request drew attention from top health officials — a telltale sign of connections. When STAT asked if...
For the first time in 105 years, medicine has something to offer type 1 diabetes patients beyond insulin. The UK's National Institute for Health and Care Excellence (Nice) has approved teplizumab (Tzield, made by Sanofi) for use on the NHS in England and Wales — the world's first drug that can delay the onset of type 1 diabetes by up to three years. The immunotherapy doesn't cure the disease, but it buys time: precious years free from finger-pricks, insulin...
The FDA announced a pilot program Monday that could shave six to 12 months off early-stage clinical trial timelines, part of a concerted push by the Trump administration to stop the United States from bleeding clinical research to China. The pilot, detailed by federal health officials on a Monday morning call, accompanies a proposed permanent overhaul of the Investigational New Drug pathway in the president's 2027 fiscal budget — a change championed by former FDA...