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FDA Approves Enbumyst (bumetanide) Nasal Spray for the Treatment of Edema Associated with Congestive Heart Failure, Liver Disease and Kidney Disease

(BUSINESS WIRE) September 15, 2025 --Corstasis Therapeutics Inc., an innovative biopharmaceutical company providing enhanced outpatient therapeutic options...

Intercept Announces Voluntary Withdrawal of Ocaliva for Primary Biliary Cholangitis (PBC) from the US Market; FDA Places US Clinical Trials on Hold

September 12, 2025. MORRISTOWN, N.J., Sept. 11, 2025 (GLOBE NEWSWIRE) -- Intercept Pharmaceuticals, Inc., a wholly owned biopharmaceutical subsidiary...

FDA Approves Selumetinib for Pediatric Patients 1 year of Age and Older with Neurofibromatosis Type 1 with Symptomatic, Inoperable Plexiform Neurofibromas

On September 10, 2025, the Food and Drug Administration approved selumetinib (Koselugo, AstraZeneca Pharmaceuticals LP) granules and capsules for pediatric...

Long COVID Linked to Abnormal Uterine Bleeding

Long COVID is associated with abnormal uterine bleeding (AUB), but not with impaired ovarian function, according to a study published online Sept. 16 in...

GLP-1 RAs Cost-Effective Versus Usual Care for Knee OA, Obesity

Compared with usual care, the glucagon-like peptide 1 receptor agonists (GLP-1 RAs) tirzepatide and semaglutide are cost-effective for people with knee...

Without Biannual Time Shift, Prevalence of Obesity, Stroke May Be Reduced

The prevalence of obesity and stroke would be reduced with permanent Standard Time (SDT) and Daylight Saving Time (DST) compared with the current Biannual...

Over-the-Counter Naloxone Shows Limited Uptake

 Sales of over-the-counter (OTC) naloxone increased in the United States after it was made available to the public then quickly declined, according...

Hair Samples May Help Spot Mental Health Risks in Sick Kids

WEDNESDAY, Sept. 17 2025 — Children with chronic illnesses face extra challenges, and measuring stress through hair samples may help doctors predict...

Wegovy May Help Quiet Constant Food Cravings, Study Finds

WEDNESDAY, Sept. 17, 2025 — A popular weight-loss drug may do more than help patients shed pounds. It could also help quiet the nonstop food cravings...

DermaRite Widens Recall to 32 Products Over Bacteria Risk

WEDNESDAY, Sept. 17, 2025 — DermaRite Industries has widened its earlier recall of hand soaps to include 32 personal care products that could be...

FDA Cracks Down on Hims, Other Telehealth Companies Over Drug Ads

WEDNESDAY, Sept. 17, 2025 — Federal health officials are cracking down on telehealth companies’ promotion of unapproved versions of prescription...

On World Sepsis Day, Doctors Urge Americans to Know the Signs

SATURDAY, Sept. 13, 2025 — On World Sepsis Day, health experts remind Americans that sepsis strikes 1.7 million people in the U.S. each year and...

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Recently added consumer and prescribing information: Enbumyst, Inlexzo, Nuvaxovid, mNEXSPIKE, Cyklx, Papzimeos, Brinsupri, Zegfrovy, Lynozyfic, Arynta

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Latest FDA New Drug Approvals

  • Enbumyst Enbumyst (bumetanide) nasal spray is a loop diuretic indicated for the treatment of edema associated with congestive heart failure, hepatic...
  • Ocaliva Ocaliva (obeticholic acid) is a first-in-class farnesoid X receptor (FXR) agonist for the treatment of primary biliary cholangitis.
  • Inlexzo Inlexzo (gemcitabine intravesical system) is a treatment for certain patients with BCG-unresponsive non-muscle invasive bladder cancer

More FDA approvals