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U.S. FDA Approves Third Indication of Nubeqa (darolutamide) for Patients with Advanced Prostate cancer
Berlin, June 3, 2025 – Bayer announced today that the U.S. Food and Drug Administration (FDA) has approved its oral androgen receptor inhibitor (ARi)...
FDA Expands Xenoview Indication to Include Children From Six Years of Age
Polarean Imaging plc (AIM: POLX), a commercial-stage medical imaging technology leader in functional Magnetic Resonance Imaging ("MRI") of the lungs, announces...
FDA Approves mNEXSPIKE (COVID-19 Vaccine, mRNA) to Prevent COVID-19
CAMBRIDGE, MA / ACCESS Newswire / May 31, 2025 / Moderna, Inc. (NASDAQ:MRNA) today announced that the U.S. Food and Drug Administration...
Preoperative Blood Pressure Strategies Yield Similar Postoperative Cognitive Results
For patients undergoing noncardiac surgery, neurocognitive outcomes do not differ with hypotension-avoidance and hypertension-avoidance strategies, according...
FDA Authorizes First AI Platform for Breast Cancer Prediction
The U.S. Food and Drug Administration has granted de novo authorization to CLAIRITY BREAST, a first-in-class, image-based platform that can help predict...
Less 'Experienced Weight Stigma' After Bariatric Surgery Aids Mental Health
Experienced weight stigma (EWS) improves from pre- to post-metabolic bariatric surgery (MBS), according to a study published online June 5 in Health Psychology. Larissa...
Dapagliflozin Beneficial for Improving MASH Without Worsening Fibrosis
For patients with metabolic dysfunction-associated steatohepatitis (MASH), treatment with dapagliflozin is beneficial for improvement of MASH without worsening...
Obesity Linked to Subsequent Neoplasms in Childhood Cancer Survivors
Body mass index (BMI) and physical activity are associated with the risk for subsequent neoplasms among childhood cancer survivors, according to a study...
4 States Ask FDA to Lift Rules on Abortion Pill Mifepristone
FRIDAY, June 6, 2025 — Attorneys general from four states are asking the U.S. Food and Drug Administration (FDA) to lift restrictions on mifepristone,...
Long-Lasting HIV Prevention Shot Headed Toward Approval
FRIDAY, June 6, 2025 — A new injection to prevent HIV is expected to be approved by the U.S. Food and Drug Administration (FDA) later this month. If...
ESPN's Jay Harris Diagnosed With Prostate Cancer
FRIDAY, June 6, 2025 — Longtime ESPN “SportsCenter” anchor Jay Harris has been diagnosed with prostate cancer and is scheduled to have...
Cellectar Granted U.S. FDA Breakthrough Therapy Designation for Iopofosine I 131 in Waldenstrom Macroglobulinemia (WM)
Cellectar Biosciences, Inc. (NASDAQ: CLRB), a late-stage clinical biopharmaceutical company focused on the discovery and development of drugs for the treatment...
Coffee Could Be Key To Aging Gracefully
WEDNESDAY, June 4, 2025 — A morning cup of coffee might do more than momentarily boost your energy and spirits. Full-test java also appears to help...
Pheast Therapeutics Receives FDA Fast Track Designation for PHST001 for the Treatment of Ovarian Cancer
Redwood City, Calif., June 3, 2025 – Pheast Therapeutics, a clinical-stage biotechnology company developing novel therapies to unleash the power...
Amneal Pharmaceutical LLC Issues a Nationwide Recall of Sulfamethoxazole / Trimethoprim Tablets, USP, 400 mg/80 mg Only, Due to Microbial Contamination
Amneal Pharmaceutical LLC, is recalling three lots of Sulfamethoxazole/Trimethoprim Tablets, USP, 400 mg/80 mg to the consumer level as the tablets may...
Kura Oncology and Kyowa Kirin Announce FDA Acceptance and Priority Review of New Drug Application for Ziftomenib in Adults with Relapsed or Refractory NPM1-Mutant AML
Kura Oncology, Inc. (Nasdaq: KURA, “Kura”) and Kyowa Kirin Co., Ltd. (TSE: 4151, “Kyowa Kirin”) today announced the U.S. Food and...
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Latest FDA New Drug Approvals
- mNEXSPIKE mNEXSPIKE (COVID-19 Vaccine, mRNA) is a vaccine indicated for active immunization to prevent COVID-19 caused by severe acute respiratory...
- Tryptyr Tryptyr (acoltremon) is a first-in-class TRPM8 thermoreceptor agonist indicated for the treatment of the signs and symptoms of dry eye disease.
- Khindivi Khindivi (hydrocortisone) is an oral solution formulation of the approved corticosteroid hydrocortisone indicated as replacement therapy in...