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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...

FDA Approves Inlexzo (gemcitabine intravesical system) for the Treatment of Non-Muscle Invasive Bladder Cancer

September 9, 2025. RARITAN, N.J., September 9, 2025 /PRNewswire/ – Johnson & Johnson (NYSE:JNJ) announced today the U.S. Food and Drug Administration...

Over 100,000 Paris Hilton Mini Fridges Recalled for Fire Risk

TUESDAY, Sept. 16, 2025 — More than 100,000 Paris Hilton-branded mini fridges are being recalled because of a risk of fire and burns, federal safety...

Self-Sufficiency Regained Immediately in Most Patients After Simultaneous Bilateral Cataract Surgery

Most patients can manage at home without help after bilateral cataract surgery, with as good or better visual outcomes, according to two studies presented...

Pilocarpine-Diclofenac Eye Drops Tied to Improvement in Presbyopia

For presbyopia management, pilocarpine-diclofenac eye drops provide dose-dependent improvement, which can be sustained over two years, according to a study...

AI Algorithm Predicts Progression of Keratoconus

An artificial intelligence (AI) algorithm can predict progression of keratoconus, according to a study presented at the annual Congress of the European...

Over-The-Counter Sales Of OD-Reversal Drug Have Been A Bust

TUESDAY, Sept. 16, 2025 — Over-the-counter sales have tanked for the overdose reversal drug naloxone, likely due to its high price, a new study says.Naloxone...

Early Breast Cancer Survivors Have Little Added Risk Of A Second Cancer, Study Says

TUESDAY, Sept. 16, 2025 — Women who survive an early breast cancer can breathe easy, a recent study says.Their risk of developing a second cancer is...

Can Weed Increase Risk Of Type 2 Diabetes?

TUESDAY, Sept. 16, 2025 — Weed might nearly quadruple a person’s risk of developing type 2 diabetes, a new study says.People who use cannabis have...

Parental Diseases of Despair Linked to Suicidal Events in Offspring

Parental diseases of despair (DoD; i.e., substance use disorder, alcohol-related disease, or suicidal behavior) are associated with suicidal events (SE)...

FDA Files Corcept’s New Drug Application for Relacorilant as a Treatment for Patients with Platinum-Resistant Ovarian Cancer

(BUSINESS WIRE)--Sep. 10, 2025-- Corcept Therapeutics Incorporated (NASDAQ: CORT), a commercial-stage company engaged in the discovery and development...

Greenwich LifeSciences’ GLSI-100 Granted US FDA Fast Track Designation

Greenwich LifeSciences, Inc. (Nasdaq: GLSI) (the "Company"), a clinical-stage biopharmaceutical company focused on its Phase III clinical trial, FLAMINGO-01,...

Caffeine Bad News For Blood Donations, Study Says

WEDNESDAY, Sept. 10, 2025 — Your morning cup of coffee might harm the quality of a blood donation provided later in the day, a new study says. Caffeine...

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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

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