FDA

Oct 22, 2024

Gilead and Merck Reports Phase II Data Showing that Switching to a Once-Weekly Oral Combination of Islatravir and Lenacapavir Maintained Viral Suppression in Adults Through 48 Weeks Gilead Sciences, Inc. and Merck have shared new findings from a Phase II clinical trial assessing the experimental combination of i...

Oct 18, 2024

In the ever-evolving world of liver disease, the shift from Nonalcoholic Steatohepatitis (NASH) to Metabolic Associated Steatotic Hepatitis (MASH) marks a revolutionary leap in our understanding and approach to treatment. This transition isn't merely a rebranding; it signifies a profound recognition of the intricat...

Oct 16, 2024

Pompe disease is a rare genetic disorder that presents a spectrum of severity, with varying rates of progression and ages of onset. Symptoms can appear anywhere from infancy to late adulthood, with earlier onset generally associated with more rapid progression and increased severity. At all ages, the disease is mar...

Oct 15, 2024

Astellas & AviadoBio Sign Exclusive Deal for Gene Therapy AVB-101 in Frontotemporal Dementia AviadoBio Ltd. and Astellas Pharma Inc. have announced a strategic partnership under an exclusive option and license agreement for AVB-101, an investigational AAV-based gene therapy currently in Phase I/II developmen...

Oct 01, 2024

IntraBio's AQNEURSA Receives Historic FDA Approval for Niemann-Pick Disease Type C Treatment IntraBio Inc. has received approval from the FDA for AQNEURSA (levacetylleucine), marking a significant milestone in the treatment of neurological manifestations of Niemann-Pick disease type C  in both adults and pe...

Sep 24, 2024

FDA Greenlights Zevra Therapeutics’ MIPLYFFA for Niemann-Pick Disease Type C Zevra Therapeutics, Inc. has announced that the FDA has approved MIPLYFFA (arimoclomol) capsules as the first oral treatment for Niemann-Pick disease type C. Indicated for use alongside miglustat, MIPLYFFA is intended for both adult and...

Sep 19, 2024

Boston Scientific Received FDA Approval For The Expanded Indication of INGEVITY™+ Pacing Leads, Allowing For Conduction System Pacing in The Left Bundle Branch Area  On September 17, 2024, Boston Scientific Corporation received U.S. Food and Drug Administration (FDA) approval to expand the indication for th...

Sep 12, 2024

Modular Medical Announced the FDA Clearance for the Modd1 Insulin Pump  On September 5, 2024, Modular Medical, Inc., an insulin delivery system technology company, announced that it received the U.S. Food and Drug Administration (FDA) clearance to market and sell its MODD1 pump in the United States. With it...

Sep 10, 2024

Biogen's Higher SPINRAZA Dose Shows Improved Efficacy in Phase II/III Trial A trial studying a higher dose of Biogen’s spinal muscular atrophy drug SPINRAZA (nusinersen) has met the primary endpoint in a cohort of infants with SMA. The Phase II/III DEVOTE study, which included 145 patients across various ages an...

Sep 03, 2024

Bayer Starts Phase III Trial In Non-Small Cell Lung Cancer (NSCLC) Bayer has officially enrolled the first patient in the global Phase III SOHO-02 trial, which will evaluate the efficacy and safety of BAY 2927088 as a first-line treatment for advanced non-small cell lung cancer (NSCLC) with activating HER2 mutat...