Duchenne muscular dystrophy
Jul 17, 2026
Top FDA Approvals to Watch in H2 2026: Regulatory Decisions Poised to Transform the Pharmaceutical Landscape
Summary H2 2026 is expected to be a highly active FDA regulatory period, with decisions spanning oncology, nephrology, infectious diseases, neurology, hematology, and rare diseases, reflecting greater therapeutic diversity beyond oncology dominance. Key innovation trends include first- and best-in-class biol...
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May 19, 2026
BAXFENDY Receives US Approval for Adult Hypertension as a First-in-Class Aldosterone Synthase Inhibitor; Regeneron Pharmaceuticals Shares New Developments in Phase 3 Melanoma Study of Fianlimab Combination; ENHERTU Gains Two New US Indications in HER2-positive Early Breast Cancer; REGENXBIO Reveals Positive Pivotal Trial Results for Duchenne Gene Therapy RGX-202; BeOne Medicines Gains FDA Approval for BEQALZI™ in R/R Mantle Cell Lymphoma
BAXFENDY Becomes the First FDA-Approved Aldosterone Synthase Inhibitor for Adults With Hypertension AstraZeneca’s BAXFENDY (baxdrostat) has received US approval as the first aldosterone synthase inhibitor (ASI) for treating hypertension in adults whose blood pressure remains uncontrolled despite the use of other...
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May 12, 2026
GSK Signs Exclusive Collaboration with SBP Group to Strengthen Commercialization of Bepirovirsen in China; Artiva Announces Strong Early AlloNK® Results and FDA Alignment for Pivotal Rheumatoid Arthritis Trial in 2026; FDA Reviews LEQEMBI IQLIK Subcutaneous Starting Dose Under Priority Review Pathway; ParcelBio Announces Programmable mRNA Platform Amid $13M Capital Infusion; Entrada Therapeutics Reports Promising Topline Efficacy and Safety Results for ENTR-601-44 in Duchenne Muscular Dystrophy
GSK Signs Exclusive Collaboration with SBP Group to Strengthen Commercialization of Bepirovirsen in China GSK plc revealed an exclusive strategic partnership with Sino Biopharmaceutical, through its subsidiary Chia Tai Tianqing Pharmaceutical Group Co., Ltd., aimed at supporting the launch and expansion of bepir...
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Mar 17, 2026
5 Promising Exosome-based Therapies Paving the Way for Personalized Medicine
The field of exosome therapeutics is rapidly evolving, with growing interest across oncology, regenerative medicine, and rare diseases. Recent exosome therapy news and exosome clinical trial news highlight how these nano-sized extracellular vesicles are unlocking new possibilities in targeted drug delivery and prec...
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Feb 17, 2026
Roche’s GAZYVA/GAZYVARO Achieves Key Phase III Success in Primary Membranous Nephropathy; Novartis’ VANRAFIA Slows Kidney Function Decline in Phase III IgA Nephropathy Trial; PTC Therapeutics Shares Latest Regulatory Developments for Translarna; BridgeBio’s Oral Infigratinib Achieves Key Body Proportionality Improvements in Phase 3 Achondroplasia Trial; Upstream Bio’s Verekitug Achieves Key Endpoints in Phase 2 Trial for Severe Asthma Treatment
Roche Reports Positive Phase III Data for GAZYVA/GAZYVARO in Primary Membranous Nephropathy Roche has reported highly encouraging results from the Phase III MAJESTY study, which evaluated the efficacy and safety of GAZYVA/GAZYVARO (obinutuzumab) in adults suffering from primary membranous nephropathy (PMN). PMN ...
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Dec 02, 2025
Novo Nordisk Seeks FDA Approval for Higher-Dose 7.2 mg WEGOVY Injection; Ascendis Pharma Granted FDA Review Extension for TransCon CNP in Children with Achondroplasia; VOYXACT Receives FDA Fast-Track Approval for Treatment of High-Risk Primary IgAN; Sarepta Begins Next ENDEAVOR Cohort Focused on Immunosuppressive Optimization for ELEVIDYS in Advanced DMD; IMFINZI Gains U.S. Approval as the Sole Perioperative Immunotherapy for Early-Stage Gastric and GEJ Cancer
Novo Nordisk Submits FDA Application for 7.2 mg Dose of WEGOVY Injection Novo Nordisk has announced the submission of a supplemental New Drug Application (sNDA) to the U.S. Food and Drug Administration (FDA) for a higher, investigational 7.2 mg dose of its once-weekly semaglutide injection, marketed as WEGOVY, f...
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Nov 18, 2025
Sarepta Secures FDA Approval of Revised Prescribing Information for ELEVIDYS; Merck to Acquire Cidara Therapeutics; BMS & J&J Halt Milvexian Phase III in ACS After Interim Review; Kura Oncology & Kyowa Kirin Win FDA Green Light for KOMZIFTI in NPM1-Mutated AML; Novartis’ Phase III KLU156 (GanLum) Trial Hits Primary Endpoint
FDA Approves Major Safety and Indication Updates for Sarepta's ELEVIDYS Gene Therapy Sarepta Therapeutics announced that the U.S. Food and Drug Administration (FDA) has approved significant updates to the prescribing information for its Duchenne muscular dystrophy (DMD) gene therapy, ELEVIDYS (delandistrogene mo...
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Aug 05, 2025
Anbogen’s ABT-301 Cleared by FDA for Phase I/II Colorectal Cancer Trial; Dyne’s DYNE-251 Gets FDA Breakthrough Tag for Duchenne Muscular Dystrophy; BMS’s BREYANZI Accepted for FDA Priority Review in MZL; Clarametyx’s CMTX-101 Earns FDA Fast Track and QIDP for Infections; Anixa Begins FDA-Approved IND Transfer for Phase II Breast Cancer Vaccine Trial
Anbogen Secures FDA Nod to Begin Phase I/II Trial of ABT-301 Triplet in Advanced Colorectal Cancer Anbogen Therapeutics has received FDA clearance to initiate a Phase I/II clinical trial of ABT-301 in combination with tislelizumab and bevacizumab for patients with metastatic colorectal cancer (mCRC). The study w...
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Jul 22, 2025
Sarepta Therapeutics Pauses ELEVIDYS Shipments in U.S. After FDA Intervention Over Patient Deaths; ImCheck’s ICT01 Granted FDA Orphan Drug Designation for Acute Myeloid Leukemia; RedHill Biopharma Gets Positive FDA Feedback on RHB-204 for Crohn’s Disease Approval Pathway; FDA Grants Fast Track Designation to ProMIS Neurosciences’ PMN310 for Alzheimer’s Disease; Oruka Therapeutics Receives IND Clearance for Phase IIa Trial of ORKA-001 in Psoriasis
Sarepta Therapeutics Pauses ELEVIDYS Shipments in U.S. After FDA Intervention Over Patient Deaths Sarepta Therapeutics, Inc. has voluntarily and temporarily paused all shipments of ELEVIDYS (delandistrogene moxeparvovec) in the U.S., effective July 22, 2025, following engagement with the FDA on safety labeling u...
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May 14, 2025
Generative AI in Drug Discovery: Applications and Market Impact
The pharmaceutical industry stands at a crossroads, where innovation is no longer a luxury but a necessity. The AI in the drug discovery market is at the forefront of this transformation, driven by the remarkable capabilities of generative AI. This technology, which creates novel solutions by learning from vast dat...
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