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FDA Approves Tonmya (cyclobenzaprine hydrochloride sublingual tablets) for the Treatment of Fibromyalgia

Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP), a fully-integrated biotechnology company, today announced that the U.S. Food and Drug Administration...

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,...

Wegovy Granted Accelerated Approval in the US for the Treatment of MASH

Bagsværd, Denmark, 15 August 2025 – Novo Nordisk today announced that the US Food and Drug Administration (FDA) has approved an additional...

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...

Prenatal Exposure to Pesticide Chlorpyrifos Linked to Brain Abnormalities

Prenatal exposure to the pesticide chlorpyrifos (CPF) is associated with altered differentiation of neuronal tissue, increased myelination of the internal...

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...

New Data Examines Health Spending Among Children With Autism

FRIDAY, Aug. 22, 2025 — Families with a child receiving treatment for autism spectrum disorder (ASD) incur almost 10 times more in health care costs...

Poor Sleep Tied To Self-Harm Among Teens

FRIDAY, Aug. 22, 2025 — Teenagers who get poor sleep are more likely to harm themselves on purpose, a new study says. Shorter sleep, going to sleep...

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

  • 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...
  • Brinsupri Brinsupri (brensocatib) is a dipeptidyl peptidase 1 inhibitor for the treatment of patients with bronchiectasis.

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