FDA
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Stanford-Developed Orca-T Wins FDA Approval as First Regulatory T Cell Therapy for Blood Cancer Transplants
STANFORD, October 10 — Stanford Medicine administered the world’s first commercial dose of Orca-T on October 7, 2026, marking the therapy’s debut…
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Manufacturing Site Issues Delay FDA Decision on Novo’s Once-Monthly Hemophilia A Drug Denecimig
Bagsværd, October 6 — Novo Nordisk confirmed on October 2 that the FDA review of its denecimig biologics license application remains delayed…
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FDA Approved All Eight Rare Disease Decisions Due in September 2026, Six of Them Early
WASHINGTON, October 2 — The FDA’s October 2026 decision calendar is relatively light compared to previous months, with a limited number of…
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Immunotherapy Emerges as the Fourth Pillar of Cancer Care, Experts Say
ISLAMABAD, September 20 — Cancer immunotherapy, the approach that harnesses the body’s own immune system to fight tumours, has become the fourth…
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Fenfluramine: From Fen-Phen scandal to seizure drug
NEW YORK, July 22 — Fenfluramine is back on the American market, a comeback twenty-three years in the making. The same drug…
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FDA Gains Expanded Powers to Prevent Foodborne Outbreaks Under 2011 Law
WASHINGTON, July 21 — Fifteen years after it became law, the Food Safety Modernization Act still stands as the most radical rewrite…
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Ernexa Moves ERNA-101 Into GMP Manufacturing Ahead of Planned IND Filing
KARACHI, July 15 — Ernexa Therapeutics is moving toward a planned first-in-human Phase 1 study for its lead cancer candidate, ERNA-101, though…
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New Alzheimer’s Drug Kisunla Carries Significant Brain Risk Factors
The U.S. Food and Drug Administration approved Eli Lilly’s monoclonal antibody donanemab, marketed as Kisunla, on July 15, 2024. The drug is…
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Akeso gets FDA and China clearance for Phase II cadonilimab liver cancer trial
BEIJING, July 15 — Akeso’s experimental cancer drug cadonilimab is now being studied in a Phase II clinical trial in the United…
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Akeso starts US Phase II cadonilimab trial in gastric cancer with Memorial Sloan Kettering
ISLAMABAD, July 15 — Akeso, the Chinese biopharmaceutical company, has advanced its investigational drug cadonilimab into a Phase II clinical trial in…
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Next-Generation CAR T-Cell Therapies Aim at Solid Tumors and Off-the-Shelf Donor Cells
SAN FRANCISCO, July 14 — The next generation of cancer immunotherapy is racing toward a milestone that could change how thousands of…
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Fentanyl Vaccine That Keeps the Drug Out of the Brain Is Set for Human Trials
ISLAMABAD, July 13 — A vaccine candidate designed to block fentanyl from reaching the brain has completed preclinical studies in animals, with…
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Immunotherapy Side Effects Affect More Than 60% of Patients, MD Anderson Says
WASHINGTON, July 10 — The strategic calculus of cancer treatment is shifting, and with it comes a new set of battlefield risks…
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FDA Immunotherapy Approvals Reach 156 Since 2011, Cancer Research Institute Reports
WASHINGTON, July 10 — The first checkpoint inhibitor landed in March 2011, a drug called ipilimumab, approved for melanoma. Since then, the…
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UCSF team reprograms T cells inside the body to clear cancer in mice
ISLAMABAD, July 10 — For patients and families facing blood cancers, the word “remission” carries a weight that is both fragile and…
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Metformin and Rapamycin: Two Anti-Aging Drug Candidates With Very Different Evidence
NEW YORK, July 8 — The calculus around aging research is shifting. Two drugs, one a decades-old diabetes staple and the other…
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FDA Approves Breyanzi CAR-T Therapy for Relapsed Chronic Lymphocytic Leukemia
MANILA, July 7 — For families across the region watching loved ones battle blood cancers that keep returning, a new treatment option…
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Emily Whitehead, First Child Given CAR T Therapy, Cancer-Free More Than Nine Years Later
PHILLIPSBURG, N.J., July 7 — In the long, often heartbreaking history of childhood cancer research, there are a handful of moments that…
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FDA Clears First Human Trial of Partial Epigenetic Reprogramming for Eye Disease
BOSTON, June 11 — Life Biosciences, a Boston-based longevity company, has started the first FDA-approved human clinical trial to turn back time…
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Abbott Buys Exact Sciences in $21B Cancer Deal
MADISON, Wis. — The stool DNA test sits in a box. Patients collect a sample at home, mail it to a lab,…
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Moderna’s New mNEXSPIKE COVID-19 Vaccine Wins FDA Approval After Phase 3 Trial
The Moderna COVID-19 vaccine, also known as Spikevax, has been a crucial tool in the fight against COVID-19, a disease caused by…
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FDA Approves Vertex’s Journavx, the First New Class of Pain Medicine in Over 20 Years
Vertex Pharmaceuticals is awaiting a regulatory decision on suzetrigine, a non-opioid analgesic designed for moderate to severe acute pain. The drug, which…
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FDA Approves Genentech’s Inavolisib for PIK3CA-Mutated Advanced Breast Cancer
On 15 October 2024, the U.S. Food and Drug Administration granted market authorization to Inavolisib, a novel therapy from Genentech, a Roche…
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FDA Approves New Schizophrenia Medication With Unique Mechanism
The U.S. Food and Drug Administration granted approval on September 15, 2024, for a new fixed-dose combination medication designed to treat schizophrenia.…
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Asian & Oceanian Epilepsy Congress 2026 in Kuala Lumpur
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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