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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...
Risk for Anal Cancer Elevated Among Women With History of Cervical Cancer
The overall standardized incidence ratio for anal cancer is elevated among women with a history of cervical cancer, according to a study published online...
Parent-Focused Interventions Do Not Prevent Obesity at Age 24 Months
Parent-focused behavioral interventions seem to be insufficient for preventing obesity at age 24 months, according to a review published online Sept. 10...
Women Still Underrepresented in Cardiovascular Trials
In recent years, challenges have persisted in representation of women within cardiovascular (CV) clinical trials, according to a study published online...
Nicotine Pouch Use May Be a Harm Reduction Strategy
The percentage of U.S. adults using nicotine pouches remains low, according to a research letter published online Sept. 8 in JAMA Network Open. Cristine...
U.S. Officials To Review COVID Vaccine Safety in Pregnancy, Kids
TUESDAY, Sept. 16, 2025 — Federal health officials are reviewing safety data on COVID vaccines in pregnant women and children, and may also reconsider...
Goodles Mac & Cheese Recalled Due to Hidden Allergen Risk
TUESDAY, Sept. 16, 2025 — Gooder Foods, Inc. is recalling eight lots of its boxed mac and cheese products because they may contain undeclared allergens,...
RFK Jr. Adds 5 Members to Vaccine Advisory Committee Ahead of Meeting
TUESDAY, Sept. 16, 2025 — Five new members have been appointed to the U.S. Centers for Disease Control and Prevention’s (CDC) vaccine advisory...
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...
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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- 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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