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U.S. FDA Approves Kerendia (finerenone) to Treat Patients with Heart Failure with Left Ventricular Ejection Fraction ≥40% Following Priority Review

WHIPPANY, N.J., July 14, 2025 – Bayer today announced that the U.S. Food and Drug Administration (FDA) approved Kerendia (finerenone) to treat patients...

Moderna Receives Full U.S. FDA Approval for COVID-19 Vaccine, Spikevax in Children Aged 6 Months Through 11 Years at Increased Risk for COVID-19 Disease

CAMBRIDGE, MA / ACCESS Newswire / July 10, 2025 / Moderna, Inc. (NASDAQ:MRNA) today announced that the U.S. Food and Drug Administration...

FDA Approves Updated Label for Lilly's Kisunla (donanemab-azbt) with New Dosing in Early Symptomatic Alzheimer's Disease

Eli Lilly and Company (NYSE: LLY) announced today that the U.S. Food and Drug Administration (FDA) has approved a label update with a new recommended titration...

FDA Approves Ekterly (sebetralstat) the First and Only Oral On-demand Treatment for Hereditary Angioedema (HAE)

CAMBRIDGE, Mass. & SALISBURY, England, July 7, 2025 (BUSINESS WIRE)--KalVista Pharmaceuticals, Inc. (Nasdaq: KALV) today announced that the U.S. Food...

Public Health Response Data Show Success of Standard Infection Control Measures for Dialysis

Adherence to standard dialysis infection prevention and control (IPC) measures enabled safe provision of dialysis to patients with Candida auris colonization...

Air Pollution, Including Ultrafine Particles, Linked to Meningiomas

Air pollution, including ultrafine particles (UFP), may be associated with developing meningiomas, according to a study published online July 9 in Neurology. Ulla...

Socioeconomic Disparities Contribute to Frequent ED Visits for Seizure

Racial/ethnic and socioeconomic disparities contribute to frequent emergency department visits for seizures, according to a study published online July...

Risk for Death From Prostate Cancer Low With Guideline Care for Nonmetastatic Disease

Men with nonmetastatic prostate cancer receiving guideline-concordant care have a much higher risk for death from causes other than prostate cancer, according...

Bread Sold at Walmart, Kroger Recalled for Hazelnut Allergy

MONDAY, July 14, 2025 — A popular brand of bread sold at Walmart, Kroger and other stores has been recalled in 12 U.S. states due to undeclared hazelnuts. Hartford...

CDC Says COVID-19 Cases Rising in 25 States

MONDAY, July 14, 2025 — COVID-19 cases are on the rise again across the United States, with the biggest increases in parts of the South, Southeast...

Arizona Resident Dies From Pneumonic Plague

MONDAY, July 14, 2025 — An Arizona resident has died from pneumonic plague, a rare but serious illness, health officials confirmed.  The death...

Diet Influences Constipation Risk, Study Says

MONDAY, July 14, 2025 — Worried about maintaining your regularity as you grow older? Changing your diet can reduce the risk of chronic constipation...

Popular Chronic Pain Med, Gabapentin, Linked To Dementia Risk

FRIDAY, July 11, 2025 — A drug used to treat seizures, nerve pain and restless leg syndrome might be linked with increased risk of dementia, a new...

Ultragenyx Receives Complete Response Letter from FDA for UX111 AAV Gene Therapy to Treat Sanfilippo Syndrome Type A (MPS IIIA)

Ultragenyx Pharmaceutical Inc. (NASDAQ: RARE), today announced that the U.S. Food and Drug Administration (FDA) has issued a Complete Response Letter (CRL)...

Capricor Therapeutics Provides Regulatory Update on Deramiocel BLA for Duchenne Muscular Dystrophy

 Capricor Therapeutics (NASDAQ: CAPR), a biotechnology company developing transformative cell and exosome-based therapeutics for rare diseases,...

FDA Grants Fast Track Designation for TRE-515 in Combination with Radiation Therapy for the Treatment of Metastatic Castration Resistant Prostate Cancer

Los Angeles, July 9, 2025 — Trethera Corporation (“Trethera”), a clinical stage biopharmaceutical company developing first-in-class...

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Recently added consumer and prescribing information: Zegfrovy, Lynozyfic, Arynta, Harliku, Ibtrozi, Miudella, Opdivo Qvantig, Alyftrek, Crenessity, Ensacove

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Latest FDA New Drug Approvals

  • Ekterly Ekterly (sebetralstat) is an oral plasma kallikrein inhibitor for the on-demand treatment of hereditary angioedema attacks in adults and...
  • Lynozyfic Lynozyfic (linvoseltamab-gcpt) is a bispecific B-cell maturation antigen (BCMA)‑directed CD3 T-cell engager for the treatment of relapsed o...
  • Zegfrovy Zegfrovy (sunvozertinib) is an oral, irreversible, epidermal growth factor receptor (EGFR) tyrosine kinase inhibitor (TKI) for the...

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