Medtronic announced that the first U.S. commercial surgical case using its recently FDA-cleared Hugo robotic-assisted surgery (RAS) system has been successfully performed by Jihad Kaouk, MD, professor and… read more.
Hansa Biopharma AB announced that its Biologics License Application (BLA) for imlifidase has been accepted by the FDA. The FDA’s filing review was completed on day 60 which… read more.
NICE(UK): Cerliponase alfa is not recommended, within its marketing authorisation, for treating neuronal ceroid lipofuscinosis type 2 (CLN2; also known as tripeptidyl peptidase 1 deficiency). This recommendation is not intended… read more.
Intellia Therapeutics Presents Longer-Term Clinical Data for Lonvoguran Ziclumeran (lonvo-z); Hereditary Angioedema (HAE) Patient-Focused Research at AAAAI 2026. Presentations include three-year follow-up data from patients receiving a one-time… read more.
Eli Lilly and Company announced the FDA approved a label expansion for Zepbound (tirzepatide) to include the four-dose single-patient use KwikPen that delivers a full month of treatment… read more.
The Medicines and Healthcare products Regulatory Agency (MHRA) has granted approval to Jazz Pharmaceuticals Research UK Limited for zanidatamab (Ziihera) in adults to treat biliary tract cancer whose cancer… read more.
The EMA’s CHMP adopted a positive opinion, recommending the granting of a conditional marketing authorisation for Kayshild (semaglutide), intended for the treatment of adults with non-cirrhotic metabolic dysfunction-associated… read more.
Pfizer Inc. announced positive topline progression-free (PFS) survival results from Cohort 3, a separate randomized cohort of the pivotal BREAKWATER trial, evaluating Braftovi (encorafenib) in combination with cetuximab… read more.
AbbVie announced that it has received marketing approval in Japan for Aquipta tablets (atogepant), a calcitonin gene-related peptide (CGRP) receptor antagonist, for the prevention of migraine attacks in… read more.
A universal respiratory syncytial virus (RSV) immunization program using Beyfortus (nirsevimab) was associated with a statistically significant reduction in RSV-related hospitalizations in the second RSV season among infants… read more.
Abivax SA announced novel preclinical and clinical data for obefazimod as part of the presentations at The European Crohn’s and Colitis Organization’s (ECCO) 21st Annual Congress. These data further… read more.
Sequel Med Tech, LLC, a company developing transformative drug delivery technologies, and Senseonics Holdings, Inc., a medical technology company focused on long-term, implantable Continuous Glucose Monitoring (CGM) systems… read more.
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