- First-in-Class approval supported by Phase 3 BROADWAY, BROOKLYN, and TANDEM trials demonstrating significant LDL-C reductions with favorable tolerability profile- - First global regulatory approval of obicetrapib marks a defining milestone for NewAmsterdam and Menarini, expanding treatment options for patients with elevated LDL-C - Sept. 21, 2026 -- NewAmsterdam Pharma Company N.V. (Nasdaq: NAMS or “NewAmsterdam” or the “Company”), a late-stage, clinical biopharmaceutical company developing

KEYTRUDA QLEX is the first and only subcutaneous immune checkpoint inhibitor in Japan that can be administered by a healthcare provider in as little as one minute Merck (NYSE: MRK), known as MSD outside of the United States and Canada, today announced the Ministry of Health, Labor and Welfare (MHLW) in Japan has approved KEYTRUDA QLEX™ (pembrolizumab and berahyaluronidase alfa-pmph) injection for subcutaneous use for all indications approved in Japan for KEYTRUDA® (pembrolizumab), Merck’s anti-

— ALKS 7290 is the First Orexin 2 Receptor Agonist to Demonstrate Clinically Meaningful Improvements in ADHD Symptoms in Adults — — ALKS 7290 Was Generally Well Tolerated at All Doses Tested in Healthy Volunteers and Adults With ADHD — — Phase 2 Study of ALKS 7290 in Adults With ADHD is Enrolling, Data Expected in 2027 — Alkermes plc (Nasdaq: ALKS) today announced positive topline results from a phase 1 proof-of-concept study evaluating ALKS 7290, the company’s novel, investigational orexin 2

New ready-to-use fluorescent imaging agent eliminates reconstitution at the point of care, giving surgical and imaging teams a differentiated option for fluorescence-guided procedures Sept. 22, 2026 -- Sagent Pharmaceuticals ("Sagent"), a leading provider of generic and specialty pharmaceuticals, today announced that Zyogreen® (indocyanine green injection), the first and only FDA-approved ready-to-use (RTU) indocyanine green (ICG) injection in the United States, is now commercially available. T

Feedback from U.S. FDA supports advancement into Phase 2 STRIDE-MDS trial in patients with R/R HR-MDS First-in-class, mutation-agnostic approach has the potential to address a broad R/R HR-MDS population PureTech intends to secure external capital in the first half of 2027 to support the continued development of LYT-200 through its Founded Entity, Gallop Oncology PureTech Health plc (LSE: PRTC) ("PureTech" or the "Company"), a hub-and-spoke biotherapeutics company dedicated to giving life to sc

Primary endpoint and the key secondary endpoint were met with high statistical significance and CUE-221 demonstrated an overall favorable safety profile Clinically different efficacy profile observed relative to XOLAIR® (omalizumab) highlights potential for a fundamental mechanism-based biological difference Cue Biopharma to host conference call on Monday, September 21, at 8:00 a.m. EDT Sept. 20, 2026 -- Cue Biopharma (Nasdaq: CUE), a clinical-stage biopharmaceutical company targeting transfo

Lōkahi Therapeutics™, a subsidiary of Glucotrack, Inc. (Nasdaq: GCTK), today announced that The University of Alabama’s Culverhouse College of Business will continue its participation in the ai² Pipeline division for the upcoming academic year. The renewed collaboration extends a hands-on program in which students evaluate real-world biopharmaceutical business development and asset assessment opportunities. The program also supports Lōkahi’s strategy of identifying and evaluating promising thera

If approved, Cosentyx (secukinumab) will be first IL-17A inhibitor licensed in Europe for adults with polymyalgia rheumatica (PMR), providing new treatment option after steroids¹ Recommendation based on data showing Cosentyx doubled sustained remission rates and delivered steroid sparing effects vs placebo; safety was consistent with established Cosentyx profile² Despite being a common inflammatory rheumatic disease in people over 50, there are limited advanced treatments for PMR; extended use o

First and only approved treatment indicated for Ataxia-Telangiectasia (A-T) in the United States or anywhere in the world Second FDA-approved indication for AQNEURSA, following previous approval for Niemann-Pick disease type C (NPC) AQNEURSA is commercially available now AQNEURSA provides a long-awaited treatment option for patients living with A-T IntraBio Inc., a leader in the discovery, development, and commercialization of novel therapies for rare and common neurodegenerative diseases, tod

—sNDA Under Review for Full Approval Is Based on Positive Results From Phase 3b ENCORE Study— —Full Approval Could Bring ARIKAYCE to Patients Earlier in Their Disease Course and Would Fulfill Post-Marketing Requirement From FDA— Sept. 21, 2026 -- Insmed Incorporated (Nasdaq: INSM), a people-first global biopharmaceutical company striving to deliver first- and best-in-class therapies to transform the lives of patients facing serious diseases, today announced that the U.S. Food and Drug Administr