pharma news
Jul 21, 2026
Novartis Secures FDA Traditional Approval for Fabhalta in Primary IgAN; GSK Reports Mixed Phase III Results for Camlipixant in Refractory Chronic Cough; Merck Secures FDA Approval for LIPFENDRA; Innovent Reports Positive Phase II Results for Soficinib in Vitiligo; Lilly Signs Deal to Acquire AtaiBeckley for Mental Health Therapies
Novartis Wins FDA Traditional Approval for Fabhalta to Treat Primary IgAN Novartis announced that the US Food and Drug Administration (FDA) has granted traditional approval to Fabhalta (iptacopan) for slowing the progression of kidney function decline in adults with primary immunoglobulin A nephropathy (IgAN) wh...
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Jul 14, 2026
Hengrui Pharma Encounters FDA Regulatory Hurdle for Camrelizumab–Rivoceranib; Kailera Therapeutics Announces Positive Results for HRS-7535/KAI-7535 Across Two Phase 3 Studies; Jemperli Underscores Durable Clinical Complete Responses in dMMR/MSI-H Rectal Cancer; FDA Approves PADCEV-Keytruda Combination for Neoadjuvant and Adjuvant Treatment of Muscle-Invasive Bladder Cancer; Sanofi’s Subcutaneous Sarclisa Escena Gains US Approval
Hengrui Pharma Receives FDA Complete Response Letter for Camrelizumab–Rivoceranib Combination in Advanced Liver Cancer Hengrui Pharma and Elevar Therapeutics have encountered another setback in their efforts to secure U.S. approval for the combination of camrelizumab and rivoceranib, as the FDA has issued a thir...
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Jul 07, 2026
Novartis to Acquire Myricx Bio; Roche’s Divarasib Tops Approved KRAS G12C Inhibitors in Phase III NSCLC Trial; Otsuka Reports Positive Two-Year Phase 3 Results for VOYXACT in IgA Nephropathy; Revolution Medicines Reports Early Clinical Data for Zoldonrasib Combination Regimens at ESMO GI 2026; Can-Fite Completes Patient Enrolment for Interim Analysis in Pivotal Phase 3 Psoriasis Trial
Novartis to Acquire Myricx Bio to Expand Next-Generation ADC Portfolio Novartis has signed an agreement to acquire Myricx Bio, a privately owned biotechnology company based in the UK that is developing a novel class of antibody-drug conjugates (ADCs) featuring N-myristoyltransferase inhibitor (NMTi) payloads. ...
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Jun 23, 2026
Definium Reports Positive Phase 3 EMERGE Results for DT120 ODT in MDD; AbbVie to Buy Apogee Therapeutics; TrueLab Announces Strategic Antibody Licensing Collaboration with Bionyra Pharma; Nura Bio Secures Series B Financing to Advance SARM1 Programs; Moderna’s mRNA-1010 Earns Unanimous FDA Advisory Committee Backing on Benefit-Risk Profile
Definium Therapeutics Advances DT120 ODT with Positive Results from Pivotal Phase 3 EMERGE Study Definium Therapeutics, Inc. reported positive topline findings from Emerge, its first Phase 3 randomized, double-blind, placebo-controlled trial assessing a single 100 µg dose of DT120 (lysergide) orally disintegrati...
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Jun 16, 2026
Ultomiris Receives US Priority Review for Adult IgA Nephropathy Treatment; FDA Approves WELIREG Plus KEYTRUDA or KEYTRUDA QLEX for Adjuvant Treatment of Select ccRCC Patients; Jazz Pharmaceuticals Highlights Phase 3 LAGOON Trial Update for Zepzelca® in Second-Line SCLC; Novartis’ delpacibart braxlosiran (del-brax) Achieves Primary Biomarker Endpoint in Phase I/II FSHD Study; Takeda’s Zasocitinib Tops Deucravacitinib in Phase 3 Psoriasis Trial, Setting a New Benchmark for Oral Therapies; IMAAVY Demonstrates Clinically Meaningful and Sustained Hemoglobin Responses in Pivotal wAIHA Study
Ultomiris Secures Priority Review Status in the US for Adult IgA Nephropathy Alexion, AstraZeneca Rare Disease announced that the FDA has accepted and granted Priority Review to the supplemental Biologics License Application (sBLA) for Ultomiris as a potential treatment for adults with Immunoglobulin A Nephropat...
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Jun 09, 2026
Roche Expands Pipeline Through Global Bexobrutideg Partnership with Nurix Therapeutics; Incyte to Acquire Vega Therapeutics; Tango Therapeutics Unveils Promising Pancreatic Cancer Data with Vopimetostat–Daraxonrasib Combination; Otsuka Announces Encouraging 12-Month eGFR Outcomes from Phase 3 VISIONARY Study of VOYXACT in IgAN; Innovent Biologics Unveils Phase 3 DREAMS-3 Findings for First Approved GCG/GLP-1 Dual Receptor Agonist
Roche and Nurix Therapeutics Partner to Advance BTK Degrader Bexobrutideg Roche has entered into an exclusive licensing and collaboration agreement with Nurix Therapeutics to jointly develop and commercialize bexobrutideg (NX-5948), Nurix’s investigational Bruton’s Tyrosine Kinase (BTK) degrader. Through this pa...
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Jun 02, 2026
Hanmi Pharmaceutical and Eli Lilly and Company Join Forces to Advance Sonefpeglutide Development; Johnson & Johnson’s ERLEADA Achieves Positive Phase 3 Outcomes; Revolution Medicines Unveils Landmark Phase 3 RASolute 302 Data Demonstrating Strong Efficacy of Daraxonrasib in Metastatic Pancreatic Cancer; Pfizer’s BRAFTOVI Treatment Advances Outcomes by Nearly Doubling Progression-Free Survival in mCRC; Imfinzi Sets a New Standard with US Approval of the Only Immunotherapy Combination for BCG-Naïve High-Risk Bladder Cancer
Hanmi Pharmaceutical Secures Licensing Agreement with Eli Lilly and Company for Sonefpeglutide Hanmi Pharmaceutical announced a licensing agreement with Eli Lilly and Company covering the development, manufacturing, and commercialization of sonefpeglutide (LAPSGLP-2 analog), Hanmi’s investigational biologi...
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May 26, 2026
US Greenlight for Datroway Marks First TROP2 ADC Approval in Frontline mTNBC Beyond PD-1/PD-L1 Candidates; Gilead’s Hepcludex Achieves Historic FDA Approval Milestone in Chronic HDV; Biogen and Denali Therapeutics Report Progress in Phase 2b Evaluation of BIIB122 for Parkinson’s Disease; Eli Lilly and Company Spotlights Foundayo’s Late-Stage Success in Obesity Studies; BioMarin Shares Successful Phase 3 Study Outcomes for VOXZOGO® in Children with Hypochondroplasia
US Approves Datroway as the First TROP2-directed ADC for 1L mTNBC Patients Unsuitable for PD-1/PD-L1 Therapy AstraZeneca and Daiichi Sankyo have secured US approval for Datroway for treating adults with unresectable or metastatic triple-negative breast cancer (TNBC) who are ineligible for PD-1/PD-L1 inhibitor th...
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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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