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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...
FDA Approves Tryptyr (acoltremon) Ophthalmic Solution for the Treatment of Dry Eye Disease
(BUSINESS WIRE) May 28, 2025 -- Alcon (SIX/NYSE: ALC), the global leader in eye care dedicated to helping people see brilliantly, today announced the U.S....
FDA Approves Khindivi (hydrocortisone) Oral Solution for Pediatric Patients with Adrenocortical Insufficiency
Eton Pharmaceuticals, Inc (“Eton” or “the Company”) (Nasdaq: ETON), an innovative pharmaceutical company focused on developing...
US Food and Drug Administration (FDA) Grants Interchangeability Designation to Samsung Bioepis and Organon Hadlima (adalimumab-bwwd) Injection
(BUSINESS WIRE) May 27, 2025 -- Samsung Bioepis Co., Ltd. and Organon & Co. (NYSE: OGN) today announced that the US Food and Drug Administration (FDA)...
Higher MIND Diet Adherence Cuts Risk for Alzheimer Disease and Related Dementias
Higher adherence to the MIND (Mediterranean-DASH Intervention for Neurodegenerative Delay) diet in mid to late life is associated with a reduced risk...
FDA Approves Tryptyr Eye Drops for Dry Eye Disease
The U.S. Food and Drug Administration has approved the first-in-class TRPM8 receptor agonist Tryptyr (acoltremon ophthalmic solution) for the treatment...
Parents Appear Receptive to Children Receiving HPV Vaccine at 9 or 10 Years of Age
Clinicians consider administration of human papillomavirus (HPV) vaccine as feasible at age 9 to 10 years, and parents appear to be receptive to discussing...
Psoriasis Tied to Increased Risk for Sleep Disorders
Both mild and moderate-to-severe psoriasis are significantly associated with an increased risk for sleep disorders, according to a study published online...
Guidelines Issued for Surgical Management of Chronic Rhinosinusitis in Adults
In a new clinical practice guideline issued by the American Academy of Otolaryngology-Head and Neck Surgery Foundation and published online May 27 in Otolaryngology-Head...
FDA Issues Highest Alert Over Tomato Recall in 3 Southern States
MONDAY, June 2, 2025 — Salmonella-tainted tomatoes in three southern states could cause severe illness or even death, the U.S. Food and Drug Administration...
Cucumber-Linked Salmonella Outbreak Sickens Dozens Across 18 States
MONDAY, June 2, 2025 — A growing salmonella outbreak tied to cucumbers has made at least 45 people sick across 18 states, U.S. health officials have...
Exercise Cuts Colon Cancer Recurrence and Boosts Survival, Study Finds
MONDAY, June 2, 2025 — A structured exercise program helped colon cancer survivors live longer and lowered their odds for a relapse, a major international...
Elinzanetant Significantly Reduces Frequency of Moderate to Severe Vasomotor Symptoms Associated with Endocrine Therapy for Breast Cancer in Phase III OASIS-4 Study
Berlin, June 2, 2025 – Detailed results from the Phase III OASIS-4 study found that the investigational compound elinzanetant showed a statistically...
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...
Johnson & Johnson Unveils First-in-Human Results for Pasritamig, Showing Early Anti-Tumor Activity in Prostate Cancer
CHICAGO, JUNE 1, 2025 – Johnson & Johnson announced today new data from a Phase 1 study evaluating pasritamig (JNJ-78278343), a first-in-class...
Stealth BioTherapeutics Announces “Path Forward” Despite Disappointing Delay for Ultra-Rare Barth Syndrome
NEEDHAM, Mass., May 29, 2025 /PRNewswire/ — Stealth BioTherapeutics Inc. (the “Company” or “Stealth”), a clinical-stage...
Patritumab Deruxtecan Biologics License Application for Patients with Previously Treated Locally Advanced or Metastatic EGFRMutated Non-Small Cell Lung Cancer Voluntarily Withdrawn
Tokyo and Basking Ridge, NJ – May 29, 2025 – The Biologics License Application (BLA) seeking accelerated approval in the U.S. for Daiichi Sankyo...
Miley Cyrus Reveals Rare Condition That Shapes Her Signature Voice
WEDNESDAY, May 28, 2025 — Singer and actress Miley Cyrus says a rare voice disorder called Reinke’s edema is behind her famous raspy voice...
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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...
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