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Merck and Amgen Focus on Cholesterol Reduction to Combat Heart Disease

Merck and Amgen Focus on Cholesterol Reduction to Combat Heart Disease

Merck and Amgen Focus on Cholesterol Reduction to Combat Heart Disease
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President Trump Considers Firing FDA Commissioner Marty Makary Amid Agency Turmoil

President Trump Considers Firing FDA Commissioner Marty Makary Amid Agency Turmoil

President Donald Trump has reportedly approved a plan to dismiss FDA Commissioner Marty Makary, following a period of significant challenges at the agency. Makary's tenure has been marked by controversial drug rejections and internal conflicts, including the refusal to review Moderna's mRNA-based flu vaccine, which was later accepted after an amended application. The decision to potentially remove Makary comes amid broader concerns about the FDA's handling of vaccine approvals and drug pricing policies. Makary, who took office in March 2025, has faced criticism for his management style and the implementation of the Commissioner's National Priority Voucher program, which has raised legal and efficacy concerns.
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Capricor Therapeutics Sues Nippon Shinyaku Over DMD Therapy Distribution Dispute

Capricor Therapeutics Sues Nippon Shinyaku Over DMD Therapy Distribution Dispute

Capricor Therapeutics Sues Nippon Shinyaku Over DMD Therapy Distribution Dispute
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Rznomics Secures FDA RMAT Designation for RZ-001 in Hepatocellular Carcinoma Treatment

Rznomics Secures FDA RMAT Designation for RZ-001 in Hepatocellular Carcinoma Treatment

Rznomics Secures FDA RMAT Designation for RZ-001 in Hepatocellular Carcinoma Treatment
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Regeneron Receives FDA Approval for First Neurosensory Gene Therapy, Otarmeni

Regeneron Receives FDA Approval for First Neurosensory Gene Therapy, Otarmeni

Regeneron Receives FDA Approval for First Neurosensory Gene Therapy, Otarmeni
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Rznomics Receives FDA RMAT Designation for RZ-001 in Hepatocellular Carcinoma Treatment

Rznomics Receives FDA RMAT Designation for RZ-001 in Hepatocellular Carcinoma Treatment

Rznomics, a biopharmaceutical company specializing in RNA-based gene therapeutics, has been granted the Regenerative Medicine Advanced Therapy (RMAT) designation by the U.S. FDA for its investigational candidate RZ-001, aimed at treating hepatocellular carcinoma (HCC). This designation is based on promising Phase 1b/2a clinical data, including safety profiles and preliminary response rates. The RMAT designation is part of an FDA program designed to expedite the development and review of innovative therapies for serious conditions. RZ-001 utilizes a trans-splicing ribozyme-based RNA editing platform, offering a novel mechanism of action to enhance tumor selectivity and safety.
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Mineral vs Chemical Sunscreen: Which is Safer and More Effective?

Mineral vs Chemical Sunscreen: Which is Safer and More Effective?

Choosing a sunscreen feels like a simple task until you hit the aisle and see "mineral" and "chemical" options. Many Americans don't realize these two types work in fundamentally different ways, impacting everything from how they feel on your skin to their long-term safety. But which one offers better protection and fewer risks for your skin in 2026? This isn't just about SPF numbers anymore. It's about ingredients, how your body reacts, and what's best for your family. The FDA continues to review many common sunscreen chemicals, while mineral options generally hold a "safe and effective" designation. We'll break down the facts so you can make an informed decision before your next trip to the beach.
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Bright Uro Gains FDA Clearance for Glean Abdominal Sensor, Enhancing Urodynamics

Bright Uro Gains FDA Clearance for Glean Abdominal Sensor, Enhancing Urodynamics

Bright Uro Gains FDA Clearance for Glean Abdominal Sensor, Enhancing Urodynamics
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FDA to Reconsider Rejection of Ebvallo Cell Therapy for Rare Disease

FDA to Reconsider Rejection of Ebvallo Cell Therapy for Rare Disease

FDA to Reconsider Rejection of Ebvallo Cell Therapy for Rare Disease
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Vistagen Completes Phase 3 Study for Fasedienol in Social Anxiety Disorder

Vistagen Completes Phase 3 Study for Fasedienol in Social Anxiety Disorder

Vistagen Completes Phase 3 Study for Fasedienol in Social Anxiety Disorder
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FDA Approves Regeneron's Otarmeni for Genetic Hearing Loss, Offering Free Access in the U.S.

FDA Approves Regeneron's Otarmeni for Genetic Hearing Loss, Offering Free Access in the U.S.

The U.S. Food and Drug Administration (FDA) has granted accelerated approval to Regeneron Pharmaceuticals for Otarmeni, a gene therapy designed to treat severe-to-profound sensorineural hearing loss. This therapy is specifically targeted at individuals with biallelic variants in the OTOF gene, who have preserved outer hair cell function and no prior cochlear implant in the same ear. The approval is based on data from the Phase I/II CHORD trial, which demonstrated significant improvements in hearing sensitivity among participants. Otarmeni is the first in vivo gene therapy for OTOF-related hearing loss and will be provided for free in the U.S. by Regeneron.
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Rznomics Receives FDA RMAT Designation for RZ-001 in Liver Cancer Treatment

Rznomics Receives FDA RMAT Designation for RZ-001 in Liver Cancer Treatment

Rznomics Receives FDA RMAT Designation for RZ-001 in Liver Cancer Treatment