pharma news
Aug 11, 2026
Sobi Partners with Innate Pharma to License Lacutamab for T-Cell Lymphoma; Yochanra Makes Global Debut in China as First Innovative Drug Designed to Overcome FGFR Inhibitor Resistance; Replimune Secures FDA Accelerated Approval for TUDRIQEV Plus Nivolumab in Advanced Cutaneous Melanoma; FDA Accepts Supplemental Biologics License Application for ENFLONSIA to Broaden RSV Indication in Young Children; Tarsus Pharmaceuticals to Acquire Alkeus Pharmaceuticals
Sobi Licenses Lacutamab from Innate Pharma to Advance Treatment of T-Cell Lymphoma Swedish Orphan Biovitrum AB (Sobi®) and Innate Pharma SA have announced a strategic partnership aimed at enabling the initiation of the TELLOMAK-3 confirmatory Phase 3 trial of lacutamab in cutaneous T-cell lymphoma (CTCL). The st...
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Aug 04, 2026
EU Approves Datroway for First-Line Metastatic TNBC; FDA Broadens Pluvicto’s Reach with Approval in PSMA+ mHSPC; AbbVie Announces EU Authorization of RINVOQ for Severe Alopecia Areata; Novo Nordisk Announces Latest Developments from the ZEUS Phase III Trial; Replimune Secures Positive FDA Advisory Committee Vote for RP1 in Advanced Melanoma
Datroway Receives EU Approval for First-Line Metastatic TNBC Patients Ineligible for Immunotherapy AstraZeneca and Daiichi Sankyo have secured European Commission approval for Datroway (datopotamab deruxtecan) as a monotherapy for the first-line treatment of adults with unresectable or metastatic triple-negative...
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Jul 28, 2026
Ultomiris Phase III Trial Update Highlights Progress in Post-Transplant TMA; argenx Acquires Forte Biosciences; Otsuka’s SIMTRIYO Receives FDA Nod as a First-in-Class ADHD Treatment; Outlook Therapeutics Secures FDA Approval for LYTENAVA to Treat Wet AMD; Merck Reveals Future Access Strategy for Once-Monthly Oral HIV Prevention Therapy Alimatravir
Phase III Ultomiris Trial Reports Progress in Adults and Adolescents with HSCT-Related TMA Topline findings from the Phase III ALXN1210-TMA-313 trial indicated that Ultomiris (ravulizumab) did not meet the primary endpoint of event-free survival over 26 weeks versus placebo in adults and adolescents (12 years an...
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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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