FDA
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FDA orders class-wide GLP-1 label update for rare eye disease risk
The FDA requires all GLP-1 drugs, including Ozempic and Mounjaro, to warn of potential NAION risk, a rare condition causing sudden vision…
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Why Oncology Trials Chase Surrogate Endpoints the FDA Ignores
An analysis of how trial designs focused on immune response metrics bypass FDA requirements, potentially delaying approvals for lifesaving cancer combinations.
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Inside AbbVie’s High-Stakes Neuro Portfolio and Pipeline Strategy
Following recent neuro-pharmaceutical acquisitions and drug approvals, we assess AbbVie’s pipeline strategy, financial impact, and key shareholder risks.
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Overcoming Immunotherapy Resistance Takes Center Stage at SITC 2026
Researchers at the SITC annual meeting tackle major cancer immunotherapy challenges, from metabolic resistance mechanisms to novel combination trials.
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How Amivantamab’s Dual EGFR-MET Blockade Overcomes Resistance in Head and Neck Cancer
The first new drug in a decade for advanced HNSCC uses a bispecific antibody to hit two escape pathways at once, doubling…
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Inovio’s First FDA Approval Tests Whether DNA Medicines Can Pay Off for Retail Investors
Voceryq’s accelerated approval for a rare throat disease gives the Plymouth Meeting biotech its first product revenue, but confirmatory trials and a…
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Generic HIV Shot Cuts Cost to $40, Unlocking Access in 120 Low-Income Countries
FDA approval of Dr. Reddy’s lenacapavir generic enables affordable, twice-yearly HIV prevention for millions in developing regions.
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Dendritic Cell Cancer Vaccines: One FDA Approval, Most Others Still in Trials
Only sipuleucel-T is approved for advanced prostate cancer; private clinics like Immunocine in Mexico sell personalized dendritic cell therapies still in clinical…
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CAR-T Cell Therapy Explained: How It Works, Approved Blood Cancers, and Key Risks
An oncologist’s viral reel calls it revolutionary; here is the plain guide to the treatment, its FDA-approved uses, response data, and serious…
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Could the Moderna-Merck Melanoma Vaccine Win FDA Approval Within Two Years? What We Know
Intismeran met primary endpoints in phase 3, but FDA filing date remains unannounced as companies race toward potential 2027 approval.
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How New Immunotherapy Aims to Break the Cycle of Surgery for RRP Patients
The FDA has approved VOCERYQ, a novel DNA-based immunotherapy designed to reduce the need for repeated surgical interventions in adults with RRP.
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FDA Approves Tirzepatide to Reduce Heart Attack Risk in Type 2 Diabetes
The FDA has approved tirzepatide (Mounjaro) for cardiovascular risk reduction, marking a shift from glucose-only control to comprehensive heart protection based on…
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Waters and Labcorp partner to expand FDA-approved HPV testing options by late 2026
Diagnostic leaders aim to reshape cervical cancer screening availability through a nationwide network offering comprehensive genotyping via clinician-collected and at-home samples.
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RFK Jr. Orders FDA to Allow Unapproved Peptide Injections
Health Secretary Robert F. Kennedy Jr. orders the FDA to halt enforcement on six unapproved wellness peptides, prompting safety concerns from scientists…
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FDA Draft Guidance Would Let Individualized Gene Editing Variants Share One License Application
New regulatory framework aims to streamline submissions for multiple gene therapy variants under a single application, addressing critical gaps in oversight for…
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Why Microsatellite Instability Status Dictates Rectal Cancer Treatment Choices
MSI-H status identifies rectal cancer patients who may avoid surgery via dostarlimab, a new FDA-approved immunotherapy targeting defective DNA repair.
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First Human Data on ER-100: What the Sinclair-Linked Eye Gene Therapy Actually Showed
Phase 1 trial of OSK gene therapy in three glaucoma patients finds no serious side effects and preliminary visual field improvements at…
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Thymalin’s Immune Claims Rest on One Russian Research Group, Not Western Trials
The Russian thymus peptide promoted online as an immune booster lacks FDA approval and independent Western trials, relying on a single Soviet-era…
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Understanding the FDA’s Accelerated Approval of Iberdomide for Multiple Myeloma
The FDA’s August 2026 approval of iberdomide introduces a new class of cancer drugs for patients with relapsed or refractory multiple myeloma.
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Viatris Secures FDA Approval for RYZUMVI to Treat Presbyopia in Adults
Viatris wins FDA approval for RYZUMVI to treat presbyopia, adding a new option for aging eyes while seeking a U.S. commercial partner.
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Thyroid Eye Disease Affects 16 in 100,000 Women Yearly, Smoking Multiplies Risk
Thyroid eye disease, linked to Graves’ disease, occurs in 16 per 100,000 women annually, with smoking increasing risk nearly eightfold and severe…
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FDA Approves Zanvastro, the First Drug for the Rare Brain Disorder Alexander Disease
Madison, October 16 — The US Food and Drug Administration has approved Zanvastro, the first drug designed to directly treat Alexander disease,…
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FDA expands Anktiva approval to cover papillary-only bladder cancer, first treatment for this group
The FDA has broadened Anktiva’s use with BCG to include patients with BCG-unresponsive, high-grade papillary-only non-muscle-invasive bladder cancer, offering a bladder-preserving option…
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Two FDA-Approved MASH Drugs Give Patients New Options, and UCLA Health Offers a Way to Choose
LOS ANGELES, October 14 — On this date, the U.S. Food and Drug Administration granted approval to two drugs, Resmetirom and semaglutide,…
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Martin Lewis Warns Savers With £10,000 or More They Could Owe Tax on Interest
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Asian & Oceanian Epilepsy Congress 2026 in Kuala Lumpur
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Baby & Beyond Maternity Expo in Kuala Lumpur 2026
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Axos Offers 5.00% Savings Rate for Six Months After Fed Hike, With Strings Attached
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First Human Data on ER-100: What the Sinclair-Linked Eye Gene Therapy Actually Showed
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FDA orders class-wide GLP-1 label update for rare eye disease risk
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Why Oncology Trials Chase Surrogate Endpoints the FDA Ignores
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Understanding Metastatic Prostate Cancer Prognosis and Modern Treatment Pathways
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Nangibotide Targets Acute-on-Chronic Liver Failure With Phase 2 Data Due 2027
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SABR Versus Surgery: New Study Reveals Mortality Gap for Early-Stage Lung Cancer
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BMS GPRC5D CAR-T Arlo-cel Shows Deep Responses After BCMA Failure
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Understanding the FDA’s Accelerated Approval of Iberdomide for Multiple Myeloma
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Rockefeller’s 2141-V11 Trial Shows Complete Remission in Two Metastatic Cancer Patients
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Ellie Sullivan: Genetic Testing Refused for a Decade, Then Offered After Her Diagnosis
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Personalized mRNA Cancer Vaccine Succeeds in First Phase 3 Melanoma Trial
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Indiana University Study Ties Delayed Colorectal Cancer Treatment to Higher Metastasis Risk
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Study: People Who Drank More Water With Meals Ate More Food, Not Less
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Why Mornings Are Hardest With ADHD: Late Body Clocks, Poor Sleep and Dopamine
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Immunotherapy and Genome-Based Vaccines Put the Immune System to Work Against Disease
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Geneticist John Hardy Proposed Alzheimer’s Amyloid Hypothesis in 1992