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FDA Approves Inlexzo (gemcitabine intravesical system) for the Treatment of Non-Muscle Invasive Bladder Cancer

September 9, 2025. RARITAN, N.J., September 9, 2025 /PRNewswire/ – Johnson & Johnson (NYSE:JNJ) announced today the U.S. Food and Drug Administration...

Infants Without Comorbidities Also at Risk for Severe RSV Infection

Comorbidities are seen less often in severe respiratory syncytial virus (RSV) infection in infants younger than 3 months compared with older children,...

Recommendations Developed for Managing Pregnancy in Women With IBD

In a global consensus statement published online Aug. 28 in Clinical Gastroenterology and Hepatology, recommendations are presented for managing pregnancy...

FDA Approves Inlexzo for Bladder Cancer

The U.S. Food and Drug Administration has approved Inlexzo (gemcitabine intravesical system) for the treatment of patients with certain types of bladder...

Features of Immunesenescence Present in Early Stages of Rheumatoid Arthritis

Some features of immunesenescence are present in the very early stages of rheumatoid arthritis (RA), according to a study published online Sept. 3 in eBioMedicine. Karim...

Urine Biomarker Panel Sensitive, Specific for Prostate Cancer Diagnosis

A urine-based biomarker panel has high accuracy for diagnosing prostate cancer (PCa), according to a study published in the September issue of eBioMedicine. Menglang...

Endangered Shark Meat Found in U.S. Grocery Stores, Study Says

THURSDAY, Sept. 11, 2025 — Shark meat sold in the U.S. may come from endangered species without consumers realizing it, a new study warns. Researchers...

High THC Levels May Affect Egg Quality and Fertility, New Study Finds

THURSDAY, Sept. 11, 2025 — High levels of THC — the compound in marijuana that causes a “high” — may affect how eggs develop...

COVID-19 Falls From Top 10 U.S. Causes of Death for First Time Since 2020

THURSDAY, Sept. 11, 2025 — For the first time since the pandemic began, COVID-19 dropped out of the nation’s top 10 causes of death in 2024,...

'Kissing Bug' Disease Spreading in U.S., CDC Report Says

TUESDAY, Sept. 9, 2025 — Chagas disease — a potentially serious illness spread by an insect called the “kissing bug” — may...

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Recently added consumer and prescribing information: Inlexzo, Nuvaxovid, mNEXSPIKE, Cyklx, Papzimeos, Brinsupri, Zegfrovy, Lynozyfic, Arynta, Harliku

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Latest FDA New Drug Approvals

  • Inlexzo Inlexzo (gemcitabine intravesical system) is a treatment for certain patients with BCG-unresponsive non-muscle invasive bladder cancer
  • Wayrilz Wayrilz (rilzabrutinib) is a kinase inhibitor indicated for the treatment of adult patients with persistent or chronic immune...
  • Dawnzera Dawnzera (donidalorsen) is a prekallikrein-directed antisense oligonucleotide indicated for prophylaxis to prevent attacks of hereditary...

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