- Company’s third program to enter clinical development leveraging FORCE platform with the goal of delivering functional improvement in rare neuromuscular disease - July 28, 2026 -- Dyne Therapeutics, Inc. (Nasdaq: DYN), a clinical-stage company focused on delivering functional improvement for people living with genetically driven neuromuscular diseases, today announced that it has received clearance from the U.S. Food and Drug Administration (FDA) for its IND application to initiate a Phase 1

July 27, 2026 -- Agency issues "study may proceed" letter; development pathway does not require a clinical endpoint efficacy study. DifGen Pharmaceuticals LLC today announced that the U.S. Food and Drug Administration (FDA) has accepted the company's Investigational New Drug (IND) application and issued a "study may proceed" letter for DFGN-101, an intramuscular injection under development for the treatment of advanced or metastatic breast cancer in women. DFGN-101 is designed to be administer

July 27, 2026 -- AbelZeta Pharma, Inc. ("AbelZeta" or the "Company"), a global clinical-stage biopharmaceutical company focused on the discovery and development of innovative and proprietary cell-based therapeutic products, today announced that the Company received the U.S. Food and Drug Administration (FDA) clearance under its Regenerative Medicine Advanced Therapy (RMAT) designation regarding the multiple-center registrational Phase II clinical trial for C-CAR168, an anti-CD20/BCMA bispecific

July 27, 2026 -- InnoCare Pharma (HKEX: 09969; SSE: 688428), a leading biopharmaceutical company focusing on the treatment of cancer and autoimmune diseases, announced today that its novel TYK2 (Tyrosine Kinase 2) inhibitor fadeucravacitinib (ICP-488) met the primary endpoint in the registrational Phase III clinical study in patients with moderate-to-severe plaque psoriasis. The Phase III study is a randomized, double-blind, placebo-controlled, multicenter registrational clinical trial designed

Filing supports potential development of radiopharmaceuticals, T-cell engagers and other immune-based approaches using a versatile platform approach July 27, 2026 / Aptevo Therapeutics Inc. (NASDAQ:APVO), a clinical-stage biotechnology company developing novel multispecific immuno-oncology therapeutics, today announced a new solid tumor strategy designed to fight cancer on multiple fronts. The Company has filed a patent application covering a proprietary Nectin-4 x PD-L1 dual-targeting backbone

SIMTRIYO is the first and only norepinephrine, dopamine, serotonin reuptake inhibitor (NDSRI) approved for the treatment of ADHD in adults and pediatric patients aged 6 years and older weighing at least 20kg SIMTRIYO will be commercially available later this year following scheduling by the U.S. Drug Enforcement Administration (DEA) Approval is supported by results from four pivotal Phase 3 clinical trials in adults and pediatric patients demonstrating statistically significant and clinically me

Recommendation based on DESTINY-Breast09 phase 3 trial results that showed Enhertu plus pertuzumab reduced the risk of disease progression or death by 44% versus THP with a median progression-free survival exceeding three years If approved, Daiichi Sankyo and AstraZeneca’s Enhertu plus pertuzumab would become first new treatment in the EU in more than a decade for first-line HER2 positive metastatic breast cancer Enhertu® (trastuzumab deruxtecan) in combination with pertuzumab has been recomme

Multi-faceted strategy aims to enable rapid, broad and sustainable access to alimatravir (MK-8527), if approved, in low- and middle-income countries Voluntary licensing agreements cover 129 countries in regions which account for the substantial majority of new HIV diagnoses globally As Phase 3 trials continue, Merck is committed to advancing access plans, working in close collaboration with the HIV community and global health stakeholders Merck (NYSE: MRK), known as MSD outside of the United

First-to-Market Generic Entry Underscores Par Health's Commitment to Expanding Access to High-Quality, Affordable Medicines July 24, 2026 -- Par Health, Inc. ("Par Health" or the "Company"), a global pharmaceutical company and manufacturer of essential medicines, today announced the launch of its generic version of Merck's Janumet® XR (sitagliptin and metformin HCl extended-release) tablets for oral use, following final approval from the U.S. Food and Drug Administration (FDA) of its Abbreviated

-- FDA clearance of the IND, together with the previously cleared CTA, establishes a global Phase 1/2 clinical program for PM577a -- -- PM577a targets the H1069Q mutation in the ATP7B gene, the most prevalent WD-causing allele in North America and Europe -- -- Initial clinical data expected in 2027 -- July 23, 2026 -- Prime Medicine, Inc. (Nasdaq: PRME), a biotechnology company committed to delivering a new class of differentiated one-time curative genetic therapies, today announced that the U.