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FDA Approves Grafapex (treosulfan) Preparative Regimen for Allogeneic Hematopoietic Stem Cell Transplantation
On January 22, 2025, Medexus was informed that the FDA approved Grafapex, an alkylating agent, with fludarabine as a preparative regimen for allogeneic...
Spravato (esketamine) Approved in the U.S. as the First and Only Monotherapy for Adults with Treatment-Resistant Depression
Titusville, New Jersey, January 21, 2025 – Johnson & Johnson (NYSE: JNJ) announced today the U.S. Food and Drug Administration (FDA) approval...
Trump Administration Puts Freeze on Release of Health Info From Government Agencies
President Donald Trump's administration has placed a freeze on information being released from government health agencies.According to a memo obtained...
Guidance Developed for Diagnosis, Management of Eosinophilic Esophagitis
In a clinical guideline issued by the American College of Gastroenterology and published in the January issue of the American Journal of Gastroenterology,...
Recent Decades Saw Rise in Sedative, Hypnotic, Anxiolytic Use Disorders
Diagnoses of sedative, hypnotic, or anxiolytic use disorders (SHA-UD) increased threefold to fivefold between 2001 and 2019 for adolescent and young adult...
Metrics From Wearable Devices Can Predict IBD Flares
Physiological metrics from wearable devices can help identify inflammatory bowel disease (IBD) flares, according to a study published online Jan. 16 in...
Multiparametric MRI Expedites Treatment in Muscle-Invasive Bladder Cancer
Incorporating multiparametric magnetic resonance imaging (mpMRI) for initial staging can reduce the time to correct treatment (TTCT) for patients with...
Bird Flu Outbreak Forces Culling of 100,000 Ducks, Threatening Last Duck Farm in Long Island
The last duck farm on New York's Long Island is facing an uncertain future after a bird flu outbreak forced the culling of nearly 100,000 ducks. The highly...
FDA Formaldehyde Ban in Hair Products on Hold Once Again
A proposed ban on formaldehyde in chemical hair straightening products -- linked to cancer and other health risks -- has hit a roadblock after an executive...
Abortion Pill Alternative Found in Morning-After Pill
When one abortion pill faces lawsuits, another may be waiting in the wings, a new study suggests. The study, published Jan. 23 in the journal NEJM Evidence,...
Stealth BioTherapeutics Announces PDUFA Action Date Extension for Elamipretide to Treat Patients with Barth Syndrome
NEEDHAM, Mass., Jan. 23, 2025 /PRNewswire/ — Stealth BioTherapeutics Inc. (the “Company” or “Stealth”), a clinical-stage...
Tris Pharma Announces Positive Results from ALLEVIATE-1 Phase 3 Clinical Trial of Cebranopadol, an Investigational First-in-Class Oral Dual-NMR Agonist, for the Treatment of Moderate-to-Severe Acute Pain
MONMOUTH JUNCTION, NJ, January 22, 2025 – Tris Pharma, Inc. (Tris), a commercial-stage biopharmaceutical company, today announced positive topline...
Humanetics Corporation Announces Positive Phase 2 Clinical Trial Results in COVID-19 Study Aimed at Improving Pulmonary Function
January 22, 2025 -- Humanetics Corporation (Humanetics) announced today the results of its Phase 2 clinical trial of BIO 300 Oral Suspension (BIO 300)...
Trump Ends Push To Slash Prescription Drug Costs
With a sweep of the pen, President Donald Trump has ended a Biden administration effort to lower the cost of prescription drugs for people on Medicare...
Drug Safety Communication: Copaxone, Glatopa (glatiramer acetate) - FDA Adds Boxed Warning About a Rare but Serious Allergic Reaction Called Anaphylaxis
ISSUE: The FDA is warning about the risk of a rare but serious allergic reaction with the medicine glatiramer acetate (Copaxone, Glatopa), which is used...
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Recently added consumer and prescribing information: Opdivo Qvantig, Alyftrek, Crenessity, Ensacove, Steqeyma, Yesintek, Revuforj, Danziten, Aucatzyl, Emrosi
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Latest FDA New Drug Approvals
- Grafapex Grafapex (treosulfan) is an alkylating agent indicated in combination with fludarabine as a preparative regimen for allogeneic...
- Datroway Datroway (datopotamab deruxtecan-dlnk) is a TROP2-directed antibody and topoisomerase inhibitor conjugate used for the treatment of hormone...
- Opdivo Qvantig Opdivo Qvantig (nivolumab and hyaluronidase-nvhy) is a programmed death receptor-1 (PD-1)-blocking antibody and hyaluronidase combination...
Drugs in Development (Not yet approved)
- Yutrepia Yutrepia (treprostinil) is an inhaled dry powder formulation of treprostinil tentatively approved for the treatment of pulmonary arterial...
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