pharma news
Mar 17, 2026
Sana Biotechnology Reveals Long-Term Positive Data from Type 1 Diabetes Islet Cell Transplant Trial; Bayer’s Finerenone Demonstrates Efficacy in Phase III FIND-CKD Study in Non-Diabetic CKD Population; Immutep Halts Phase III NSCLC Trial; REGENXBIO’s RGX-202 Demonstrates Promising Interim Results in Phase I/II AFFINITY DUCHENNE Trial; Ultragenyx’s DTX301 Gene Therapy Delivers Positive 36-Week Phase 3 Data
Sana Biotechnology Reports Sustained Positive 14-Month Results from Type 1 Diabetes Islet Cell Transplant Study Without Immunosuppression Sana Biotechnology reported continued positive clinical results from its cell therapy programs, reinforcing its broader strategy of developing engineered cells as medicines. T...
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Mar 03, 2026
Merck’s WELIREG Advances with FDA Priority Review in Early RCC Supported by Compelling DFS Evidence; Roche’s Fenebrutinib Delivers Another Phase III Victory; Positive CHMP Opinion Paves Way for Novartis’ Remibrutinib in CSU Treatment; Pfizer’s BRAFTOVI Regimen Gains FDA’s Full Nod for Initial Treatment of Metastatic Colorectal Cancer; VYVGART Achieves Positive Results in Phase 3 ADAPT OCULUS Trial
Merck’s WELIREG Secures Priority FDA Review for Adjuvant Treatment in Early RCC Driven by Pivotal DFS Improvement Merck announced landmark results from its Phase 3 LITESPARK-022 trial, which evaluated the combination of KEYTRUDA (pembrolizumab) and WELIREG (belzutifan) as an adjuvant treatment for patients with ...
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Feb 24, 2026
Gilead Sciences to Acquire Arcellx in Strategic Move to Accelerate Anito-cel Development; Novo Nordisk Faces Setback as CagriSema Underwhelms Against Rival Therapy in Trial; Vanda Pharmaceuticals Secures FDA Approval for BYSANTI; All-oral Calquence + venetoclax Combo Clears in the US for First-line Treatment of CLL; Merck’s ENFLONSIA Demonstrates Strong Protection Against Severe RSV in Young Children Over Consecutive Seasons
Gilead Sciences Announces Acquisition of Arcellx to Advance Long-Term Growth of Anito-cel Gilead Sciences announced a definitive agreement to acquire Arcellx, a clinical-stage biotechnology company, in a strategic move to strengthen its leadership in cell therapy and oncology innovation. The acquisition builds o...
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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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Feb 10, 2026
Sanofi Advances wAIHA Program as Rilzabrutinib Receives Breakthrough and Orphan Status; Lilly Moves to Acquire Orna Therapeutics, Expanding Cell Therapy Portfolio; Roche Announces Key PPMS Trial Success for Fenebrutinib; Priovant’s Brepocitinib Demonstrates Strong Potential in Phase 2 Cutaneous Sarcoidosis Study; AstraZeneca’s DATROWAY Grants US Priority Review for 1L mTNBC Indication in Patients not Eligible for Immunotherapy
Sanofi’s Rilzabrutinib Granted Breakthrough and Orphan Designations for wAIHA Rilzabrutinib (WAYRILZ) by Sanofi (EPA: SAN) recently achieved two major regulatory milestones: FDA Breakthrough Therapy Designation in the U.S. and Orphan Drug Designation by the Japanese Ministry of Health, Labour and Welfare for the...
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Feb 03, 2026
Novo Nordisk A/S Announces that CagriSema Delivered Superior Outcomes in REIMAGINE 2; Sanofi’s Venglustat Clears all Primary Hurdles in Phase 3 Gaucher Disease Trial; Kyowa Kirin Reacquires Full Development and Commercialization Rights for Rocatinlimab; IMFINZI Receives CHMP Recommendation for Perioperative Treatment in Patients with Resectable Gastric and Gastroesophageal Cancers; Tenpoint Wins FDA Approval for First-Ever Combination Presbyopia Eye Drop
Novo Nordisk A/S Reports that CagriSema Achieved a 1.91-percentage-point HbA1c Reduction and 14.2% Weight Loss in Adults with Type 2 Diabetes in the REIMAGINE 2 Study Novo Nordisk announced top-line findings from REIMAGINE 2, a phase 3 study within the global REIMAGINE programme. The results show that CagriSema ...
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Jan 27, 2026
Sanofi Strengthens Amlitelimab’s Position in Atopic Dermatitis; Corcept Announces Statistically Significant Overall Survival Benefit in Phase 3 ROSELLA Study; CORXEL Raises $287M Series D1 for Cardiometabolic Pipeline Expansion; IntraBio’s Levacetylleucine Demonstrates Positive Results in Pivotal Ataxia-Telangiectasia Trial; Otsuka Secures FDA Acceptance and Priority Review for Centanafadine in ADHD
Sanofi’s Amlitelimab Demonstrates Promise in Atopic Dermatitis Following the positive findings from the COAST 1 trial (NCT06130566) reported in September 2025, two additional global Phase 3 studies, SHORE (NCT06224348) and COAST 2 (NCT06181435), have further strengthened the clinical evidence supporting amliteli...
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Jan 13, 2026
Insilico Medicine Moves Garutadustat into Phase IIa Following First Patient Dosing; Sustained Therapeutics Reports Encouraging Phase 2 Outcomes for Long-Acting Non-Opioid Chronic Pain Drug; ZYUS Life Sciences Shares Early Results from Ongoing Phase 2a UTOPIA-1 Pain Trial; Merck Advances KRAS G12C Program With Phase 3 Calderasib Combination Study in NSCLC; Sanofi’s Teizeld Gains EU Approval for Early-stage Type 1 Diabetes
Insilico Medicine Doses First Patient in Phase IIa Trial of Garutadustat for Inflammatory Bowel Disease Insilico Medicine has dosed the first patient in its Phase IIa clinical trial of Garutadustat, an AI-designed small-molecule therapy being developed for Inflammatory Bowel Disease (IBD), specifically ulcerativ...
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Jan 06, 2026
Zenas BioPharma’s Obexelimab Delivers Positive Phase 3 Results in IgG4-RD; Sanofi Secures US Priority Review for Tzield in Pediatric Stage 2 Type 1 Diabetes; Axsome’s AXS-05 sNDA Accepted by FDA with Priority Review for Alzheimer’s Agitation; Vanda’s NEREUS Receives FDA Approval; Omeros’ YARTEMLEA Sets Milestone as First Approved TA-TMA Therapy
Zenas BioPharma Announces Successful Phase 3 INDIGO Study of Obexelimab in IgG4-RD Zenas BioPharma has announced positive top-line results from its pivotal Phase 3 INDIGO clinical trial evaluating obexelimab for the treatment of IgG4-Related Disease (IgG4-RD). IgG4-RD is a rare, systemic, chronic fibroinflammato...
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Dec 30, 2025
Novo Nordisk Gains US Approval for Oral WEGOVY; Windward Bio Strengthens Immunology Pipeline With Clinical-Stage Bispecific WIN027; US FDA Grants Breakthrough Therapy Designation to ENHERTU in the Post-neoadjuvant Setting for HER2-positive Early Breast Cancer; Ipsen Enhances Early R&D Pipeline via Simcere Zaiming ADC; Roche Secures FDA Approval for SC Lunsumio VELO in Follicular Lymphoma
Novo Nordisk Secures US Approval for WEGOVY Novo Nordisk has achieved a significant regulatory milestone with the U.S. FDA approval of WEGOVY (semaglutide) for the treatment of obesity in pediatric patients aged 12 years and older. While WEGOVY has already revolutionized the adult weight management market, this ...
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