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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...

California Resident Infected With Plague, Likely from Flea at Lake Tahoe

THURSDAY, Aug. 21, 2025 — A resident of South Lake Tahoe, California, has been diagnosed with the plague, the state’s first human plague infection...

Worse Emotional Health-Related QoL Seen for Women With Cirrhosis, Ascites

Women with cirrhosis and ascites experience worse health-related quality of life (HRQoL) than men, although no difference is seen in daily function, according...

Helping Others Linked to Higher Level of Cognitive Function

Helping others, both via formal volunteering and informal helping, is associated with higher levels of cognitive function and slower cognitive decline,...

TAR-200 Monotherapy Promising for BCG-Unresponsive Bladder Cancer

For patients with Bacillus Calmette-Guérin (BCG)-unresponsive high-risk non-muscle-invasive bladder cancer (NMIBC), an intravesical gemcitabine-releasing...

Metabolic Syndrome Linked to Increased Risk for Parkinson Disease

Metabolic syndrome (MetS) is associated with an increased risk for Parkinson disease (PD), according to a study published online Aug. 20 in Neurology. Xinjie...

FDA Approves Papzimeos for Adults With Recurrent Respiratory Papillomatosis

The U.S. Food and Drug Administration has approved Papzimeos (zopapogene imadenovec-drba) for the treatment of adults with recurrent respiratory papillomatosis...

Note-Taking AI Reduces Doctor Burnout

THURSDAY, Aug. 21, 2025 — It can be spooky to realize that Alexa or Siri has been listening in on you, when a device in your home inadvertently springs...

Infections From Flesh-Eating Bacteria Are Spreading to New Areas

THURSDAY, Aug. 21, 2025 — Health experts across the country are issuing warnings about a surge in infections from a "flesh-eating" bacterium known...

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...

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...

New Blood Pressure Guidelines Highlight Lifestyle Changes, Tailored Treatment

FRIDAY, Aug. 15, 2025 — Nearly half of U.S. adults should receive earlier treatment for high blood pressure, including lifestyle changes and medications,...

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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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