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FDA Panel Delivers Mixed Verdict on AstraZeneca's Cancer Drugs

FDA Panel Delivers Mixed Verdict on AstraZeneca's Cancer Drugs

FDA Panel Delivers Mixed Verdict on AstraZeneca's Cancer Drugs

US FDA authorizes early access to Revolution's pancreatic cancer pill

US FDA authorizes early access to Revolution's pancreatic cancer pill

May 1 (Reuters) - The U.S. Food and Drug Administration has authorized the granting of early access before regulatory approval to Revolution Medicines’ pill for patients with previously treated pancreatic cancer, the company said on Friday.

FDA Advisory Committee Rejects AstraZeneca's Breast Cancer Drug Due to Trial Design Concerns

FDA Advisory Committee Rejects AstraZeneca's Breast Cancer Drug Due to Trial Design Concerns

FDA Advisory Committee Rejects AstraZeneca's Breast Cancer Drug Due to Trial Design Concerns

FDA Expands Access to Promising Pancreatic Cancer Drug, Offering Hope to Patients

FDA Expands Access to Promising Pancreatic Cancer Drug, Offering Hope to Patients

The FDA has expanded access to a new pancreatic cancer drug, daraxonrasib, allowing certain patients to receive it before official approval. The drug, developed by Revolution Medicine, is a daily pill that inhibits cancer cell growth. Clinical trials showed that patients with metastatic pancreatic cancer who took daraxonrasib had a median survival of 13 months, compared to six months with chemotherapy. Former Senator Ben Sasse, who has stage-four pancreatic cancer, credits the drug with significantly reducing his pain and tumor size. The FDA's expanded access program, also known as 'compassionate use,' enables patients with serious conditions to use investigational therapies outside clinical trials.

FDA Advisory Committee Recommends Against AstraZeneca's Breast Cancer Drug Approval

FDA Advisory Committee Recommends Against AstraZeneca's Breast Cancer Drug Approval

FDA Advisory Committee Recommends Against AstraZeneca's Breast Cancer Drug Approval

FDA Advisory Committee Recommends TRUQAP for PTEN-Deficient Prostate Cancer

FDA Advisory Committee Recommends TRUQAP for PTEN-Deficient Prostate Cancer

The FDA's Oncologic Drugs Advisory Committee has recommended AstraZeneca's TRUQAP (capivasertib) in combination with abiraterone and androgen deprivation therapy (ADT) for treating PTEN-deficient metastatic hormone-sensitive prostate cancer. The recommendation is based on the CAPItello-281 Phase III trial, which demonstrated a favorable benefit-risk profile for the drug combination. The trial showed a significant reduction in the risk of disease progression and improved survival outcomes for patients. This marks the first targeted treatment combination to show benefits in this specific subtype of prostate cancer, addressing a significant unmet need for patients with limited treatment options.

FDA's ODAC Delivers Mixed Results for AstraZeneca's Cancer Treatments

FDA's ODAC Delivers Mixed Results for AstraZeneca's Cancer Treatments

FDA's ODAC Delivers Mixed Results for AstraZeneca's Cancer Treatments

FDA Halts Newron's U.S. Enrollment in Schizophrenia Study After Patient Death

FDA Halts Newron's U.S. Enrollment in Schizophrenia Study After Patient Death

The FDA has temporarily paused Newron Pharmaceuticals' enrollment of new patients in the U.S. for its Phase 3 ENIGMA-TRS 2 trial, following a patient death. The trial is testing evenamide, an antipsychotic agent for treatment-resistant schizophrenia. The death occurred outside the U.S. and was deemed unrelated to the drug. Despite the pause in the U.S., the trial continues in other countries, including India and Argentina. Evenamide works by modulating glutamate levels in the brain, and previous studies have shown it reduces schizophrenia symptoms. Newron is also conducting another trial, ENIGMA-TRS 1, across multiple regions.

FDA Advisory Committee to Review AstraZeneca's Cancer Drug Applications Amid Concerns

FDA Advisory Committee to Review AstraZeneca's Cancer Drug Applications Amid Concerns

The FDA is set to hold its first drug-related advisory committee meeting in nine months to evaluate AstraZeneca's applications for two cancer drugs. The meeting will focus on the oral SERD drug camizestrant for HR-positive, HER2-negative breast cancer and the AKT inhibitor Truqap for metastatic hormone-sensitive prostate cancer. The FDA has raised questions about the clinical benefits and trial designs of these drugs, particularly regarding the validity of results and the timing of treatment interventions. The advisory panel will assess whether AstraZeneca has provided sufficient evidence to support the clinical benefits of these drugs.

Novocure Reports Strong Q1 2026 Financial Results with Growth in Optune Gio Therapy

Novocure Reports Strong Q1 2026 Financial Results with Growth in Optune Gio Therapy

Novocure Reports Strong Q1 2026 Financial Results with Growth in Optune Gio Therapy

FDA Halts Newron's Schizophrenia Study After Patient Death, Safety Review Underway

FDA Halts Newron's Schizophrenia Study After Patient Death, Safety Review Underway

FDA Halts Newron's Schizophrenia Study After Patient Death, Safety Review Underway

FDA Halts Newron's Schizophrenia Study After Patient Death

FDA Halts Newron's Schizophrenia Study After Patient Death

The FDA has paused patient enrollment in Newron Pharmaceuticals' Phase 3 ENIGMA-TRS 2 trial for its schizophrenia drug, evenamide, following a patient death. The death occurred outside the U.S. and was deemed unrelated to the drug. The trial, which is testing evenamide for treatment-resistant schizophrenia, continues in other countries, including India and Argentina. Evenamide is an antipsychotic agent that works by blocking voltage-gated sodium channels to restore glutamate balance. Phase 2 data showed that evenamide reduced disease severity and psychosis symptoms, with benefits maintained over a year. Newron is also conducting another study, ENIGMA-TRS 1, across multiple regions.