FDA
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FDA Approves Lazertinib With Amivantamab as First-Line Treatment for EGFR Lung Cancer
For patients with a common form of lung cancer, a new treatment option arrived in the United States on August 15, 2024.…
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FDA Approves Voranigo, a Daily Pill That Delays Progression of Low-Grade Glioma
Each year, about 1,500 Americans receive a diagnosis of grade 2 glioma, a slowly progressing yet aggressive brain tumor. Until now, treatment…
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FDA Approves Yuhan’s Lazertinib, First Korean-Developed Cancer Drug to Win Approval
South Korea, August 16, 2024 — cyberinktimes.com — Almost four years after South Korean regulators gave it the green light, Lazertinib has…
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Lazertinib Approved in US for Non-Small Cell Lung Cancer Treatment
In August 2024, the U.S. Food and Drug Administration granted approval for lazertinib, expanding the therapeutic arsenal against non‑small cell lung cancer…
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FDA Approves Eli Lilly Alzheimer’s Drug Kisunla Amid Safety Concerns
July 18, 2024 — infopulsetoday.com — The path to the FDA’s July 15 approval of donanemab was paved with controversy, clinical risk,…
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FDA Approves Eli Lilly’s Donanemab for Early Symptomatic Alzheimer Disease
On July 15, 2024, the US Food and Drug Administration (FDA) approved donanemab, a monoclonal antibody developed by Eli Lilly and Company,…
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FDA Approves Imetelstat for Treating Myelodysplastic Syndromes with Anemia
In a pivotal shift for the cancer treatment landscape, the US Food and Drug Administration (FDA) granted approval on June 15, 2024,…
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FDA Advisers Vote Against MDMA Therapy for PTSD, Citing Flawed Trial Data
On June 5, 2024, an advisory committee to the Food and Drug Administration voted that the current evidence does not support approving…
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FDA Panel Rejects MDMA Therapy for PTSD Approval
A significant decision was made by a panel of the United States Food and Drug Administration on June 5, 2024, as they…
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FDA Approves Lung Cancer Drug Augtyro for ROS1-Positive Tumors, Trial Shows Responses
The U.S. Food and Drug Administration granted approval on November 15, 2023, for Repotrectinib, marketed as Augtyro, to treat a defined group…
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FDA Approves New Oral Pill Zuranolone for Postpartum Depression
On August 15, 2023, the United States Food and Drug Administration granted approval to Zuranolone, a medication that will be marketed under…
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FDA Grants Accelerated Approval to Talquetamab, a T-Cell Engager for Myeloma
For patients with multiple myeloma who have run out of options, August 15, 2023, changed the calculus. That day, regulators in the…
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Talquetamab Wins FDA Accelerated Approval, Then European Approval, for Relapsed Multiple Myeloma
United States, August 16, 2023 — cybernewschronicle.com — On August 15, 2023, the medical community marked a significant milestone with the approval…
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FDA Grants Accelerated Approval to Elrexfio for Heavily Treated Multiple Myeloma
/ HTML. So we need headings maybe and paragraphs . Must not add any extra info. Must keep facts: FDA approved Elranatamab…
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European Commission Approves Niraparib and Abiraterone Tablet for BRCA-Mutated Metastatic Prostate Cancer
European Union, April 19, 2023 — cybernewschronicle.com — Niraparib/abiraterone acetate, a fixed-dose combination anti-cancer medication, has been approved for the treatment of…
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US Approves New Gene Therapy For Bladder Cancer Treatment
In December 2022 the U.S. Food and Drug Administration granted approval to nadofaragene firadenovec, sold under the brand name Adstiladrin, marking the…
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FDA Approves Adstiladrin, First Gene Therapy for BCG-Unresponsive Bladder Cancer
United States, December 20, 2022 — cybernewschronicle.com — Nadofaragene firadenovec, a gene therapy marketed under the brand name Adstiladrin, has been approved…
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FDA Approves Pluvicto for Advanced Prostate Cancer Treatment
A radiopharmaceutical known as Lutetium (177Lu) vipivotide tetraxetan has become available for patients with a specific form of advanced prostate cancer following…
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FDA Grants Accelerated Approval to Elahere for FRalpha-Positive Platinum-Resistant Ovarian Cancer
The U.S. Food and Drug Administration granted approval on November 15, 2022, to Mirvetuximab soravtansine, a new medication marketed as Elahere, for…
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FDA Approves Elahere for FRα-Positive Ovarian Cancers
November 17, 2022 — infopulsetoday.com — On November 15, 2022, the FDA approved a drug that works like a guided missile. Mirvetuximab…
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FDA Approves Lilly’s Mounjaro, a Once-Weekly Dual-Action Drug for Type 2 Diabetes
Millions of Americans who live with type 2 diabetes now have an additional medication to consider. Tir tirzepatide, cleared by the U.S.…
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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