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 […]

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 […]

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), […]

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 […]

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 […]

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 […]

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 […]

CHMP recommends Opdivo + Yervoy for first line treatment of metastatic esophageal squamous cell 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) plus Yervoy (ipilimumab) for the first-line treatment of adults with unresectable advanced, recurrent or metastatic esophageal squamous cell carcinoma (ESCC) with tumor cell PD-L1 expression greater than 1%. The European Commission (EC), which has […]

Kerendia approved in EU for adult patients with chronic kidney disease associated with type 2 diabetes – Bayer HealthCare

The European Commission has granted marketing authorization in the European Union (EU) for finerenone under the brand name Kerendia from Bayer HealthCare. Kerendia (10 mg or 20 mg), a non-steroidal, selective mineralocorticoid receptor antagonist, is indicated for the treatment of chronic kidney disease (stage 3 and 4 with albuminuria) associated with type 2 diabetes in adults. “Even when blood glucose […]

Positive early access decision by French Haute Autorité de Santé to use Idefirix as desensitization treatment for highly sensitized kidney transplant patients – Hansa Biopharma AB

Hansa Biopharma AB, the pioneer in enzyme technology for rare immunological conditions, announced that its first-in-class treatment Idefirix (imlifidase) has been granted early access post marketing authorization (Autorisation d’accès précoce) in France by French HAS (Haute Autorité de Santé) for use in the desensitization of highly sensitized adult patients prior to kidney transplant, in accordance with the patient population specified […]