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FDA Approves Dawnzera (donidalorsen) as the First and Only RNA-targeted Prophylactic Treatment for Hereditary Angioedema

(BUSINESS WIRE)--Aug. 21, 2025-- Ionis Pharmaceuticals, Inc. (Nasdaq: IONS) announced today that the U.S. Food and Drug Administration (FDA)...

Liberal RBC Transfusion Strategy Suggested for Acute Myocardial Infarction

A liberal red blood cell (RBC) transfusion strategy is suggested for hospitalized patients with acute myocardial infarction (AMI) when the hemoglobin concentration...

AAP Updates Screening Guidance for Child Mental Health, Behavioral Problems

In a clinical report issued by the American Academy of Pediatrics and published online Aug. 25 in Pediatrics, updated recommendations are presented for...

Discordance Seen Between Care Goals, Treatment Intent in Advanced Cancer

More patients with advanced cancer report that their treatment discordantly focuses on longevity over comfort than patients with other illnesses, according...

29 Percent of Infants Immunized Against RSV in 2023 to 2024 Season

Overall, 29 percent of infants born during October 2023 to March 2024 were immunized against respiratory syncytial virus (RSV) during the 2023 to 2024...

NYC Legionnaires' Outbreak: 6 Deaths, 112 Cases

MONDAY, Aug. 25, 2025 — New York City health officials confirmed a sixth death linked to a Legionnaires’ disease outbreak in Harlem where 112...

Over 32,000 Pounds of Meat Recalled Over False USDA Inspection Labels

MONDAY, Aug. 25, 2025 — More than 32,000 pounds of meat are being recalled nationwide because they were sold with a false USDA mark of inspection,...

Mississippi Declares Public Health Emergency Over Infant Deaths

MONDAY, Aug. 25, 2025 — Mississippi has declared a public health emergency after reporting its highest infant death rate in more than a decade. In...

Community Health Workers Can Help Minority Kids Access ADHD Care

MONDAY, Aug. 25, 2025 — Community health workers could help extend care to more minority children with ADHD, a new pilot study says. Parents of...

FDA Update on the Safety of Ixchiq (Chikungunya Vaccine, Live)

Today the US FDA’s Center for Biologics Evaluation and Research has suspended the biologics license for Valneva Austria GmbH’s live-attenuated...

Metabolic Syndrome Linked To Parkinson's Disease, Study Says

THURSDAY, Aug. 21, 2025 — Folks with metabolic syndrome have up to a 40% higher risk of developing Parkinson’s disease, a new study says. Metabolic...

Stealth Biotherapeutics Announces FDA Acceptance of Elamipretide NDA Resubmission

NEEDHAM, Mass., Aug. 21, 2025 /PRNewswire/ — Stealth BioTherapeutics, a clinical-stage biotechnology company focused on the discovery,...

Viking Therapeutics Announces Positive Top-Line Results from Phase 2 VENTURE-Oral Dosing Trial of VK2735 Tablet Formulation in Patients with Obesity

Viking Therapeutics, Inc. ("Viking") (NASDAQ: VKTX), a clinical-stage biopharmaceutical company focused on the development of novel therapies for metabolic...

PTC Therapeutics Receives Complete Response Letter for Vatiquinone NDA

 PTC Therapeutics, Inc. (NASDAQ: PTCT) announced today that the U.S. Food and Drug Administration (FDA) has issued a Complete Response...

Voluntary Nationwide Recall of Lactated Ringer’s Injection USP 1000 mL and 0.9% Sodium Chloride Injection USP 1000 mL

BETHLEHEM, PA – August 19, 2025 – B. Braun Medical Inc. (B. Braun) is voluntarily recalling two lots of Lactated Ringers Injection USP 1000...

Altimmune Announces FDA Fast Track Designation for Pemvidutide in Alcohol Use Disorder (AUD)

GAITHERSBURG, Md., Aug. 19, 2025 (GLOBE NEWSWIRE) -- Altimmune, Inc. (Nasdaq: ALT), a late clinical-stage biopharmaceutical company...

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Latest FDA New Drug Approvals

  • Dawnzera Dawnzera (donidalorsen) is a prekallikrein-directed antisense oligonucleotide indicated for prophylaxis to prevent attacks of hereditary...
  • Tonmya Tonmya (cyclobenzaprine hydrochloride) is a sublingual formulation of cyclobenzaprine hydrochloride indicated for the treatment of...
  • Papzimeos Papzimeos (zopapogene imadenovec-drba) is a non-replicating adenoviral vector-based immunotherapy indicated for the treatment of adults...

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