pharma news
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 ...
Read More...
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...
Read More...
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 ...
Read More...
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...
Read More...
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...
Read More...
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...
Read More...
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 ...
Read More...
Dec 23, 2025
Novo Nordisk Seeks FDA Approval for CagriSema; EU Approves Subcutaneous Self-administration of SAPHNELO via Pre-filled Pen for SLE; Cytokinetics Secures FDA Approval of MYQORZO for Adult Patients with Symptomatic Obstructive HCM; Boehringer’s JASCAYD Wins FDA Approval for Adult Pulmonary Fibrosis; BioMarin to Acquire Amicus for $4.8B, Advancing Long-Term Growth in Rare Diseases
Novo Nordisk Submits CagriSema for FDA Review as a Once-weekly GLP-1–amylin Combination Therapy for Weight Management Novo Nordisk has officially filed a New Drug Application (NDA) with the U.S. FDA for CagriSema, a once-weekly subcutaneous injection intended for chronic weight management. CagriSema represents a...
Read More...
Dec 16, 2025
Pilatus Biosciences Advances PLT012 Into the Clinic Following FDA IND Clearance; ENHERTU + pertuzumab Receives US Approval as the First New First-line Option in a Decade for HER2-positive Metastatic Breast Cancer; Sanofi Reports on Tolebrutinib Development in Primary Progressive MS; Gilead Reports Positive Phase 3 Results for Bictegravir–Lenacapavir Investigational HIV Therapy; argenx Announces Study Update for UplighTED Program of Efgartigimod SC in Thyroid Eye Disease
Pilatus Biosciences Receives FDA IND Clearance for PLT012, a Novel Anti-CD36 Metabolic Checkpoint Antibody Pilatus Biosciences has announced that the U.S. Food and Drug Administration (FDA) has cleared its Investigational New Drug (IND) application for PLT012, a first-in-class, humanized anti-CD36 monoclonal ant...
Read More...
Dec 09, 2025
Kallyope’s Elismetrep Achieves Primary and Secondary Endpoints in Phase 2b Clinical Study; IDEAYA Secures IND Approval to Initiate Clinical Evaluation of IDE034; OMISIRGE Receives FDA Approval; Agios Updates on Regulatory Path for Mitapivat to Treat Thalassemia; Mirum to Acquire Bluejay Therapeutics
Kallyope Reports Successful Phase 2b Trial Outcomes for Elismetrep in Acute Migraine Treatment Kallyope, a late-stage biotechnology company focused on neurological and metabolic therapies, announced positive results from its Phase 2b dose-ranging study of the lead candidate, elismetrep (K-304), for the acute tre...
Read More...
-Agonist.png "Toll-like Receptors Agonist")
