Positive full results from the ​BaxHTN Phase III trial showed ​baxdrostat demonstrated a statistically significant and clinically meaningful reduction in mean seated systolic blood pressure (SBP) at two doses (2mg and 1mg) compared with placebo at 12 weeks. Results were seen in patients with hard-to-control (uncontrolled and resistant) hypertension who received baxdrostat or placebo on top of standard of care. These data were presented today in a Hot Line session at the European Society of Cardi

CHICAGO, Aug. 29, 2025 /PRNewswire/ -- The Alzheimer's Association welcomes today's U.S. Food and Drug Administration (FDA) action to approve weekly subcutaneous maintenance dosing of Leqembi® (lecanemab, Eisai/Biogen) for early Alzheimer's disease. With this approval, Leqembi IQLIK is the first monoclonal antibody that clears amyloid beta for the treatment of early Alzheimer's disease that is approved for subcutaneous administration using an autoinjector. Patients who have completed their 18-mo

STOCKHOLM, Aug. 29, 2025 /PRNewswire/ -- BioArctic AB's (publ) (Nasdaq Stockholm: BIOA-B) partner Eisai announced today the U.S. Food and Drug Administration (FDA) has approved the Biologics License Application (BLA) for once weekly lecanemab subcutaneous injection for maintenance dosing. LEQEMBI IQLIK autoinjector is indicated for maintenance dosing to treat Alzheimer's disease (AD) in patients with mild cognitive impairment (MCI) or mild dementia stage of disease, collectively referred to as

Ajovy (fremanezumab-vfrm) Emgality (galcanezumab-gnlm) Nurtec ODT (rimegepant) Ubrelvy (ubrogepant) Vyepti (eptinezumab-jjmr) Hypertension The "Warnings and Precautions", "Adverse Reactions", "Patient Counseling Information", and "Patient Information" sections of the labeling were updated in March 2025 to include information about the risk of hypertension. Example: Ajovy labeling Apriso (mesalamine) Asacol (mesalamine) Asacol HD (mesalamine) Azulfidine (sulfasalazine) Azulfidine EN-Tabs (sulfasa

Addyi (flibanserin) Drug hypersensitivity The "Contraindications", "Warnings and Precautions", "Adverse Reactions", and "Medication Guide" sections of the labeling were updated in September 2021 to include hypersensitivity reactions. Addyi labeling Glucagon-like peptide-1 (GLP-1) analogues Adlyxin (lixisenatide) Bydureon (exenatide) Bydureon BCise (exenatide) Byetta (exenatide) Ozempic (semaglutide) Rybelsus (semaglutide) Saxenda (liraglutide) Soliqua (insulin glargine and lixisenatide) Trulicit

Adcetris (brentuximab vedotin) Guillain-Barre syndrome FDA determined that no action is necessary at the time based on available information. Arzerra (ofatumumab) Gazyva (obinutuzumab) Riabni (rituximab-arrx) Rituxan (rituximab) Rituxan Hycela (rituximab and hyaluronidase human) Ruxience (rituximab-pvvr) Truxima (rituximab-abbs) Colitis FDA determined that no action is necessary at the time based on available information. Balversa (erdafitinib) Calciphylaxis The "Warnings and Precautions", "Pati

BOSTON, Aug. 29, 2025 /PRNewswire/ -- Ginkgo Bioworks (NYSE: DNA) today released the following notice: A Federal Court authorized this Notice. This is not a solicitation from a lawyer. TO: ALL PERSONS OR ENTITIES WHO OR WHICH HELD SHARES OF GINKGO BIOWORKS HOLDINGS, INC. ("GINKGO" OR "THE COMPANY") COMMON STOCK AS OF THE CLOSE OF TRADING ON MAY 27, 2025 (THE "RECORD DATE"). PLEASE TAKE NOTICE that the above-captioned Federal Derivative Actions and another consolidated Derivative Action pending i

Christie VeinViewer® vascular imaging has been selected to exhibit at the Vizient® Innovative Technology Exchange on September 17, 2025 in Las Vegas. We are pleased to invite Christie Medical to the Exchange.” — Kelly Flaharty, Senior Director of Contract Services, Vizient ORLANDO, FL, UNITED STATES, August 29, 2025 / EINPresswire.com / -- Christie Medical Holdings, Inc has been selected to exhibit VeinViewer ® , a breakthrough solution harnessing near-infrared (NIR) technology to provide real-t

This recall involves removing certain devices from where they are used or sold. The FDA has identified this recall as the most serious type. This device may cause serious injury or death if you continue to use it Affected Product Product name Part number Lot numbers Breathing circuit set, coaxial 260128 199675 Breathing circuit set, coaxial 260128 199676 What to Do Do not use any breathing circuits from affected lots. Replace any affected breathing circuits in use with patients and discard the a

The FDA approved Sanofi’s BTK inhibitor that the French drugmaker acquired in its $3.7 billion buyout of Principia Biopharma. The company said Friday that the regulators cleared rilzabrutinib in a rare disease called immune thrombocytopenia, or ITP. The drug is branded as Wayrilz. The wholesale acquisition cost for Wayrilz will be $17,500 a month, which is before discounts, rebates or patient assistance programs, a Sanofi spokesperson said. Wayrilz is part of a larger effort at Sanofi to become