June 6, 2023

Presentation of Ingezza capsules data on tardive dyskinesia improvement regardless of baseline antipsychotic use at 2023 Psych Congress Elevate – Neurocrine Biosciences

Neurocrine Biosciences, Inc. presented findings from a meta-analysis of three long-term studies evaluating Ingrezza (valbenazine) capsules that demonstrated substantial and sustained improvements in tardive dyskinesia (TD) in adults with or without concomitant antipsychotic therapy. The data (Poster #4) were presented at 2023 Psych Congress Elevate in Las Vegas. The analysis of the three studies (KINECT 3, KINECT 4, and J-KINECT) […]

admin Health 0 4 min read
June 4, 2023

Primary results of the FROZEN-AF IDE trial with the POLARx cryoablation system – Boston Scientific

– Primary results of the FROZEN-AF IDE trial with the POLARx Cryoablation System :Results from the global, prospective, non-randomized, single-arm FROZEN-AF IDE study of the POLARx Cryoablation System met the safety and effectiveness endpoints of the trial. The study, which examined use of the device for the treatment of patients with paroxysmal, or intermittent atrial fibrillation (AF), included an extension […]

admin Health 0 57 sec read
June 3, 2023

FDA approval for Inpefa to treat heart failure – Lexicon Pharma

Lexicon Pharmaceuticals, Inc. announced that the FDA has approved Inpefa (sotagliflozin), a once-daily oral tablet to reduce the risk of cardiovascular death, hospitalization for heart failure, and urgent heart failure visit in adults with: heart failure or type 2 diabetes mellitus, chronic kidney disease, and other cardiovascular risk factors. The broad label encompasses heart failure patients across the full range […]

admin Health 0 41 sec read
August 16, 2022

Medtronic receives FDA expanded approval for cardiac cryoablation catheters for pediatric treatment of a common heart rhythm condition

Medtronic plc a global leader in healthcare technology, announced that the Freezor and Freezor Xtra Cardiac Cryoablation Catheters are approved by the FDA and are the only ablation catheters approved to treat the growing prevalence of pediatric Atrioventricular Nodal Reentrant Tachycardia (AVNRT). AVNRT is the most common form of supraventricular tachycardia (SVT), and is a life-threatening abnormal heart rhythm, with […]

admin Health 0 38 sec read
July 7, 2022

Positive results from phase III PRIME study of Zejula at Society of Gynecologic Oncology Meeting – Zai Lab + GSK

Zai Lab Limited presented data from the Phase III PRIME study of Zejula (niraparib) as maintenance therapy at the Society of Gynecologic Oncology annual meeting . Zejula demonstrated a statistically significant and clinically meaningful improvement in progression-free survival (PFS) with a tolerable safety profile in Chinese patients with newly diagnosed advanced epithelial ovarian, fallopian tube, or primary peritoneal cancer (collectively […]

admin Health 0 1 min read
July 6, 2022

CHMP recommends Opdivo for the adjuvant treatment of adults with muscle-invasive urothelial carcinoma – BMS

Bristol Myers Squibb announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has recommended approval of Opdivo (nivolumab) for the adjuvant treatment of adults with muscle-invasive urothelial carcinoma with tumor cell PD-L1 expression greater than 1% who are at a high risk of recurrence after undergoing radical resection. The European Commission (EC), […]

admin Health 0 54 sec read
June 30, 2022

NMPA (China) approves Paxlovid conditionally to treat COVID-19 – Pfizer

China’s medical products regulator has given conditional approval for Pfizer’s COVID-19 drug Paxlovid, making it the first oral pill specifically developed to treat the disease cleared in the country. The National Medical Products Administration said Paxlovid is approved to treat adults who have mild to moderate COVID-19 and high risk of progressing to a severe condition. Further study on the […]

admin Health 0 28 sec read
June 29, 2022

EU approves Oxbryta for hemolytic anemia due to sickle cell disease – Global Blood Therapeutics

Global Blood Therapeutics announced the European Commission (EC) has granted Marketing Authorization for Oxbryta (voxelotor) for the treatment of hemolytic anemia due to sickle cell disease (SCD) in adult and pediatric patients 12 years of age and older as monotherapy or in combination with hydroxycarbamide (hydroxyurea). Oxbryta, a once-daily, oral treatment, is the first medicine approved in Europe that directly […]

admin Health 0 59 sec read
June 28, 2022

Approval of Zynrelef by Health Canada for the management of postoperative pain – Heron Therapeutics

Heron Therapeutics, Inc., announced that Health Canada has issued a Notice of Compliance (NOC) to commercialize Zynrelef (bupivacaine and meloxicam extended-release solution) for instillation into the surgical wound for postoperative analgesia after bunionectomy, open inguinal herniorrhaphy, and total knee arthroplasty surgical procedures. Based on prior agreements with the FDA, Heron already has clinical studies underway, which it plans to submit […]

admin Health 0 36 sec read
April 2, 2022

Interim data from INSPIRE study of Alofisel shows clinical remission rate in Crohn’s disease – Takeda

Takeda announced the first six-month interim analysis results from INSPIRE, in which clinical remission was observed in 65% of patients in both cohorts who were evaluated at 6 months. INSPIRE is a European, observational, multicenter, post-approval, open-enrollment study (EUPAS24267) evaluating the real-world effectiveness and safety of Alofisel (darvadstrocel) in patients with Crohn’s disease (CD) and complex perianal fistulas. As of […]

admin Health 0 1 min read

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