I Trusted A Popular Supplement — It Shut Down My Liver
Here's why we need stricter oversight, independent third-party testing, more rigorous research and a cultural shift in how we think about ‘natural’ remedies.
Microplastics and Our Health: What Does the Science Say?
The actual science is far from the apocalyptic scenario we've been led to believe and demonstrates clearly that much of the media rhetoric is rooted far more in fear than in fact.
The Power of One: Redefining Healthcare with an AI-Driven Unified Platform
In a landscape where complexity has long been the norm, the power of one lies not just in unification, but in intelligence and automation.
LEO Pharma Topical Cream Is Now the First FDA-Approved Drug for Chronic Hand Eczema
Chronic hand eczema, which can develop from chemicals and cleansers that people use frequently for work, now has its first FDA-approved treatment. The new LEO Pharma drug, Anzupgo, is a topical cream designed to block four signaling proteins that drive inflammation.
The Myth of All-American Drugs and What Trump’s Tariffs Miss About Pharma Supply Chains
Pharmaceutical tariffs are coming, part of President Trump’s stated goal of bringing drug manufacturing back to the U.S. Untangling the sprawling, global supply chain will be complicated and expensive, and could inadvertently compete with other administration goals regarding drug pricing and availability.
Sarepta CEO: ‘We Have, I Believe, a Very Laudable History of Being Extraordinarily Transparent’
Sarepta Therapeutics knew about the death of a patient treated with its experimental gene therapy for a type of limb-girdle muscular dystrophy, but said nothing publicly for a month. Financial analysts lambasted Sarepta executives for failing to disclose the fatality when the company announced a restructuring that includes stopping work on this limb-girdle program.
Sarepta Slashes Staff, Maps Path Forward for Gene Therapy and Narrower Pipeline
Sarepta’s Elevidys will remain on the market with a black box warning. But this gene therapy for Duchenne muscular dystrophy still faces commercial headwinds and analysts say the company has work to do to win over patients and investors.
NEMT Partner Guide: Why Payers and Providers Should Choose MediDrive’s TMS
Alan Murray on improving access for medical transportation.
Bayer’s Blockbuster Hopeful Kerendia Expands its FDA Approval to Type of Heart Failure
The FDA approved Bayer’s Kerendia for reducing the risk of heart failure in patients with mildly reduced ejection fraction, a measure of how much blood the organ can pump. The daily pill was first approved in 2021 for patients with chronic kidney disease associated with type 2 diabetes.
Pledging ‘Radical Transparency,’ FDA Reveals Drug Rejection Letters — With Limits
The FDA published more than 200 complete response letters, the first step in what it describes as part of its effort to modernize the agency and improve transparency. But there are some caveats to the release of the FDA correspondence.
FDA Turns Down Capricor Cell Therapy for Cardio Complications of Rare Muscle Disease
Capricor Therapeutics said the FDA asked for more data supporting the efficacy of Deramiocel, the biotech’s off-the-shelf cell therapy for treating the heart complications of Duchenne muscular dystrophy. Those data could come from an ongoing Phase 3 study expected to yield preliminary results soon.
AI Meets Gene Editing: the Path to Plug-and-Play Drug Development
AI is no panacea, but it can have a role in turning artisanal, trial-and-error drug development into a rapid, cost-effective, data-driven process.
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Esperion Sets Its Sights on New Areas While Maintaining Commitment to Cardiovascular Health
In a recent interview, Esperion president and CEO, Sheldon Koenig talks about the reality of statin intolerance and his company’s expansion into new diseases
KalVista Drug Gets FDA Approval for Treating Acute Swelling Attacks From Rare Disease
KalVista Pharmaceuticals’ Ekterly is now FDA approved for treating acute swelling attacks from hereditary angioedema. The KalVista tablet provides an alternative to injectable or infused HAE medications from companies such as Takeda Pharmaceutical and CSL Behring.
With FDA Nod in Lung Cancer, Dizal Now Aims to Best a J&J Drug and Succeed Where Takeda Fell Short
Dizal Pharmaceutical’s Zegfrovy is now FDA approved for treating non-small cell lung cancer driven by a particular rare genetic signature. Johnson & Johnson drug Rybrevant already addresses this genetic signature as an earlier line of therapy, but Dizal executives contend their drug offers the potential for better safety and efficacy.
FDA Approves Regeneron Multiple Myeloma Drug With Dosing Edge Over J&J and Pfizer Meds
Bispecific antibodies are already available for treating multiple myeloma. FDA approval of Regeneron Pharmaceuticals’ new drug, Lynozyfic, comes with dosing flexibility that sets it apart from others in its class.
FDA Just Made Some Key Regulatory Changes to Make Cancer Cell Therapies More Accessible
The FDA has eliminated a safety monitoring requirement and eased certain restrictions that had been in place since CAR T-therapies first reached the market in 2017. The agency and financial analysts say the changes should improve patient access to these personalized cancer treatments.
Gilead Sciences Lands First FDA Approval of a Twice-a-Year HIV PrEP Drug
Gilead Sciences drug lenacapavir, brand name Yeztugo, is now approved for HIV pre-exposure prophylaxis. The twice injectable medication is hoped to improve uptake and adherence to PrEP.