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Repatha Now Indicated for Adults at Increased Risk for Major Adverse Cardiovascular Events Due to Uncontrolled LDL-C
THOUSAND OAKS, Calif., Aug. 25, 2025 /PRNewswire/ -- Amgen (NASDAQ:AMGN) today announced that the U.S. Food and Drug Administration (FDA)...
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)...
Unfavorable Mental Health Outcomes Reported With THC Product Use
High-concentration delta-9-tetrahydrocannabinol (THC) cannabis products are associated with unfavorable mental health outcomes, according to a review published...
New Guideline Developed for Management of High Blood Pressure
In a new 2025 joint guideline issued by the American Heart Association and the American College of Cardiology, published online Aug. 14 in Circulation,...
Many Women Have Preexisting Modifiable Risk Factors for Birth Defects
About two-thirds of reproductive-aged women in the United States have preexisting modifiable risk factors for birth defects, according to a study published...
Benefits of Long-Term Routine Lab Drug Toxicity Monitoring Unclear in RA
For patients with rheumatoid arthritis (RA) using disease-modifying antirheumatic drugs (DMARDs), long-term routine laboratory toxicity monitoring (lt-RLTM)...
Pig Lung Transplanted Into Man for 9 Days in Groundbreaking Study
TUESDAY, Aug. 26, 2025 — Doctors in China transplanted a genetically modified pig lung into a man, where it functioned for nine days, according to...
The Experts' Guide to Safely Pumping, Storing And Thawing Breast Milk
TUESDAY, Aug. 26, 2025 — Breastfeeding offers many benefits, from emotional bonding to better nutrition and immune support. But for parents who need...
U.S. Resident Diagnosed With Rare Screwworm Parasite After Travel
TUESDAY, Aug. 26, 2025 — A Maryland resident has recovered after being diagnosed with New World screwworm — the first reported U.S. case in...
Firearm-Related Suicides Increasing Among Senior Women
TUESDAY, Aug. 26, 2025 — Senior women are becoming more likely to use a gun to end their lives, a new study says. Firearms are the leading method...
Rusfertide Receives Breakthrough Therapy Designation for Treatment of Erythrocytosis in Patients with Polycythemia Vera
NEWARK, CA / ACCESS Newswire / August 25, 2025 / Protagonist Therapeutics, Inc. ("Protagonist" or "the Company") announced today that rusfertide,...
Valneva Announces FDA’s Decision to Suspend License of Chikungunya Vaccine Ixchiq In the U.S.
Saint Herblain (France), August 25, 2025 – Valneva SE (Nasdaq: VALN; Euronext Paris: VLA), a specialty vaccine company, today announced that the...
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,...
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...
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Recently added consumer and prescribing information: Cyklx, Papzimeos, Brinsupri, Zegfrovy, Lynozyfic, Arynta, Harliku, Ibtrozi, Miudella, Opdivo Qvantig
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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...