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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...

FDA Approves Datroway (datopotamab deruxtecan-dlnk) for Patients with Previously Treated Metastatic HR Positive, HER2 Negative Breast Cancer

January 17, 2025 -- Datroway (datopotamab deruxtecan-dlnk) has been approved in the US for the treatment of adult patients with unresectable or metastatic...

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...

Fewer Bleeding Events Seen With Abelacimab Than Rivaroxaban in A-Fib

Subcutaneous injection of abelacimab results in lower levels of free factor XI and significantly fewer bleeding events than rivaroxaban in patients with...

Perioperative Chemo With FLOT Ups Survival in Resectable Esophageal Cancer

For patients with resectable esophageal adenocarcinoma, perioperative chemotherapy with fluorouracil, leucovorin, oxaliplatin, and docetaxel (FLOT) leads...

Risk for All-Cause Mortality Lower With High Muscle Strength, Fitness in Cancer

For patients diagnosed with cancer, high muscle strength and cardiorespiratory fitness (CRF) are associated with a reduced risk for all-cause mortality,...

Incidence, Prevalence of Peripartum Mental Illness Increased for Mothers With MS

Mothers with multiple sclerosis (MS) have an elevated incidence and prevalence of peripartum mental illness, according to a study published online Jan....

Adults With ADHD Linked To Shorter Life Expectancy, Study Shows

Adults with attention deficit hyperactivity disorder, otherwise known as ADHD, may face a shorter life expectancy than their peers. On average, men with...

Why Sparkling Water May (Or May Not) Help You Lose Weight

THURSDAY, Jan. 23, 2025 — Chalk up a partial win for health influencers who tout the slimming benefits of sparkling waters. New research out of...

Pregnancy Increases Mental Health Risk in MS Patients

Pregnancy increases the risk of mental illness among women with multiple sclerosis (MS). Pregnant MS patients have a higher risk of mental illness both...

Nutrition Labels Only Slightly Effective in Cutting Calories

It's easy these days to see how many calories a cheeseburger will set you back, or how many added sugars are in a jar of pasta sauce. But nutrition labels...

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...

Arrowhead Pharmaceuticals Announces Acceptance of New Drug Application by U.S. FDA of Plozasiran for the Treatment of Familial Chylomicronemia Syndrome

PASADENA, Calif.–(BUSINESS WIRE)–Jan. 17, 2025– Arrowhead Pharmaceuticals, Inc. (NASDAQ: ARWR) today announced that the U.S. Food and...

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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...

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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...

More drugs in development