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FDA Approves Yesintek (ustekinumab-kfce), a Biosimilar to Stelara

 Biocon Biologics Ltd (BBL), a fully integrated global biosimilars company and subsidiary of Biocon Ltd (BSE code: 532523, NSE: BIOCON), announced...

FDA Approves Rapiblyk (landiolol) for Atrial Fibrillation and Atrial Flutter in the Critical Care Setting

November 27th 2024 -- AOP Orphan Pharmaceuticals GmbH (AOP Health), based in Vienna, Austria, announced that the U.S. Food and Drug Administration (FDA)...

Syros Announces Topline Data from SELECT-MDS-1 Phase 3 Trial of Tamibarotene in Higher-Risk Myelodysplastic Syndrome with RARA Gene Overexpression

(BUSINESS WIRE) November 12, 2024 -- Syros Pharmaceuticals (NASDAQ:SYRS), a biopharmaceutical company committed to advancing new standards of care for...

FDA Grants Breakthrough Therapy Designation to Sacituzumab Tirumotecan (sac-TMT) for the Treatment of Certain Patients With Previously Treated Advanced or Metastatic Nonsquamous Non-Small Cell Lung Cancer With EGFR Mutations

(BUSINESS WIRE) December 3, 2024 -- Merck (NYSE: MRK), known as MSD outside of the United States and Canada, today announced that the U.S. Food and Drug...

Two Common Antiseizure Medications Do Not Harm Child Neurodevelopment

 Fetal exposure to two common antiseizure medications (ASMs) does not seem to negatively impact children's neurological development at age...

Current Prenatal Multivitamin, Mineral Labels Are Misleading

Current prenatal multivitamin and mineral (PMVM) labels are misleading and often exclude the presence of heavy metals, according to a study published online...

Antiobesity Medications Tied to Decreased Alcohol Use

Nearly half of participants in a weight loss program who initiated an antiobesity medication and who consumed alcohol at baseline reported decreases in...

Nocturnal Enuresis More Common in Children With Sleep Apnea

Nocturnal enuresis is more common in children with obstructive sleep apnea (OSA), according to a study published online Sept. 23 in Children. María...

New Weight-Loss Advance: A Gastric Balloon You Control to Feel Full or Not

GLP-1 meds are all the rage for weight loss nowadays, but not everyone can safely take the drugs to shed pounds. Invasive weight-loss surgeries can often...

Deep Belly Fat May Help Spur Alzheimer's Decades Before Symptoms Begin

An accumulation of fat lurking around the organs of obese people is strongly linked to a buildup of Alzheimer's-linked proteins in the brain, new research...

Elton John Says He Has Lost His Sight

Pop music legend Elton John says that he can no longer see following an eye infection he battled last summer. The prolific singer-songwriter made the...

Deep Brain Stimulation Helps Two Patients Walk After Spinal Cord Injury

In 2006, Wolfgang Jäger was in his 30s when a skiing accident left the young Austrian wheelchair-bound from a spinal cord injury. Fast-forward to...

Monthly News Roundup - November 2024

Bimzelx Indications Expanded to Include Hidradenitis Suppurativa, a Debilitating Skin Condition UCB’s Bimzelx (bimekizumab-bkzx) has been granted...

Drinking Lots of Water Really Is Good for You, Study Finds

The collected evidence is in, and drinking about eight cups of water per day is, in fact, good for you. So says a University of California San Francisco...

FDA Investigating Serious Risk of Hematologic Malignancy Following Skysona (elivaldogene autotemcel)

Since approval, the Food and Drug Administration (FDA) has received additional reports of hematologic malignancies, including life-threatening cases of...

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Latest FDA New Drug Approvals

  • Yesintek Yesintek (ustekinumab-kfce) is a human interleukin-12 and -23 antagonist biosimilar to Stelara used for the treatment of plaque psoriasis...
  • Rapiblyk Rapiblyk (landiolol) is an ultra-short acting cardioselective beta-1 adrenergic blocker for for the short-term reduction of ventricular...
  • Imkeldi Imkeldi (imatinib mesylate) is an oral liquid formulation of the approved kinase inhibitor imatinib used for the treatment of certain forms...

More FDA approvals

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