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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)...
FDA Approves Papzimeos (zopapogene imadenovec-drba) for the Treatment of Adults with Recurrent Respiratory Papillomatosis
Precigen, Inc. (Nasdaq: PGEN), a biopharmaceutical company specializing in the advancement of innovative precision medicines to improve the lives of patients,...
Roll Up Your Sleeve: Flu Shot Season is At Hand
SATURDAY, Aug. 23, 2025 — With a longtime vaccine critic leading the nation’s health departments, you might be wondering whether there’s a new flu...
Vaping Tied to Increased Risk for Smoking, Other Harms in Young People
There are consistent associations between vaping and negative outcomes in young people, including subsequent smoking, substance use, and poor physical...
FDA Clears OTC Glucose Monitoring System for Weight Management
The U.S. Food and Drug Administration has cleared the Signos Glucose Monitoring System, an over-the-counter glucose monitoring system for weight management.Signos...
Sleep Apnea Increases Sudden Cardiac Arrest Risk in Children With Epilepsy
For pediatric patients with epilepsy, sleep apnea (SA) is associated with an increased risk for sudden cardiac arrest (SCA) and cardiac dysrhythmia, according...
Weather Disasters Impacted Counties With More Than 60 Percent of Drug Production Facilities
More than 60 percent of drug production facilities were located in U.S. counties with at least one disaster declaration from 2019 to 2024, according to...
Sensitive Personalities Tied to More Mental Health Conditions
People with sensitive personalities are more prone to common mental health problems such as agoraphobia and avoidant personality disorder, according to...
Fatal Snakebite at Tennessee Park Highlights Risks in the Wild
FRIDAY, Aug. 22, 2025 — Authorities in Tennessee reported a rare and tragic death after a hiker was bitten by a rattlesnake. Fatal snakebites are...
More Frozen Shrimp Recalled Amid Contamination Fears
FRIDAY, Aug. 22, 2025 — Federal officials have announced the recall of more packages of frozen shrimp that may be contaminated with a radioactive...
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...
FDA Grants Soligenix Orphan Drug Designation for the Treatment of Behçet's Disease after Reviewing Recent Phase 2 Clinical Study Results
Soligenix, Inc. (Nasdaq: SNGX) (Soligenix or the Company), a late-stage biopharmaceutical company focused on developing and commercializing products to...
Device Eliminates Bladder Cancers in 4 of 5 Cases
MONDAY, Aug. 18, 2025 — A new implant eliminated bladder cancer in more than 4 out of 5 high-risk cases, new clinical trial results show. The miniature...
Stealth Biotherapeutics Resubmits New Drug Application for Elamipretide for the Treatment of Barth Syndrome
NEEDHAM, Mass., Aug. 18, 2025 /PRNewswire/ — Stealth BioTherapeutics, a clinical-stage biotechnology company focused on the discovery,...
Novo Nordisk Lowers Cost of Ozempic to $499 per Month for Self-Paying Patients
Novo Nordisk announced the launch of a new offer that enables self-paying, eligible, type 2 diabetes patients access to authentic, FDA-approved Ozempic...
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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...
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