Latest pharma news
Sep 15, 2026
TAGRISSO Delivers Landmark Eight-Year Survival Outcomes in Early-Stage EGFR-Mutated Lung Cancer; Scholar Rock Receives FDA Approval for ISEMBYLD; Pharming’s Joenja Receives FDA Approval as First U.S. Treatment for Children With APDS; AbbVie Reports Positive Phase 3 Results for Atogepant in Menstrual Migraine; Rezera’s Ruvonoflast Delivers Positive Inflammation Results with Favorable Safety in RESOLVE-1
TAGRISSO Demonstrates Eight-Year Landmark Survival Benefit for Patients with Early-Stage EGFR-Mutated Lung Cancer Updated exploratory findings from the Phase III ADAURA trial demonstrated that AstraZeneca’s Tagrisso (osimertinib) continued to provide a sustained and clinically meaningful overall survival (OS) be...
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Sep 08, 2026
Novo Nordisk’s STEP Young Phase 3 Results Highlight Semaglutide’s Potential in Pediatric Obesity; Clover Reports Positive Phase 2 Clinical Findings for RSV + hMPV ± PIV3 Vaccine Candidates; Novartis Reveals Topline Results From Phase III Lp(a)HORIZON Trial of Pelacarsen; US Approves Etcamah Plus CDK4/6 Inhibitor for 1st-Line Advanced HR-Positive Breast Cancer; ZANVASTRO Wins FDA Approval as a First-of-Its-Kind Disease-Modifying Treatment for Alexander Disease
Novo Nordisk’s STEP Young Phase 3 Study Shows Semaglutide Reduced Obesity Classification in 40.4% of Children Novo Nordisk announced the initial results from the STEP Young Phase 3 trial, which evaluated once-weekly semaglutide in combination with lifestyle modifications, including a reduced-calorie diet and inc...
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Sep 01, 2026
Takeda’s MIMRYLO Wins U.S. FDA Approval for Polycythemia Vera; Lilly’s Mounjaro Gains FDA Approval for Cardiovascular Risk Reduction in Type 2 Diabetes; Teva Expands Neuroscience Portfolio Through Proposed Acquisition; BioNTech Ends Phase 2 Study of Autogene Cevumeran in Colorectal Cancer; AusperBio Secures $120 Million Series C to Advance AHB-137 and Next-Generation Hepatitis B Therapies
Takeda Gains FDA Approval for MIMRYLO Takeda announced that the U.S. Food and Drug Administration (FDA) has approved the New Drug Application (NDA) for MIMRYLO™ (rusfertide) to treat erythrocytosis in adults with polycythemia vera (PV), a type of blood cancer. MIMRYLO is a first-in-class hepcidin mimetic develop...
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Aug 25, 2026
US FDA Grants Priority Review to Jemperli for dMMR/MSI-H Locally Advanced Rectal Cancer; Amylyx’s Avexitide Achieves Positive Topline Results in Phase 3 LUCIDITY Study; Ultragenyx Marks Major Milestone as FDA Approves GENGLYCOS for GSDIa; Pasatru Receives FDA Approval for Fibrodysplasia Ossificans Progressiva; Merck and Moderna’s Intismeran Autogene Plus KEYTRUDA Delivers Positive Phase 3 Results in Resected Melanoma
GSK’s Jemperli Granted FDA Priority Review for dMMR/MSI-H Locally Advanced Rectal Cancer GSK plc announced that the US Food and Drug Administration (FDA) has accepted its supplemental Biologics License Application (sBLA) for priority review of Jemperli (dostarlimab) as a potential treatment for patients with pre...
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Aug 18, 2026
AstraZeneca Discontinues Phase III eVOLVE-Lung02 Trial of Volrustomig in Metastatic NSCLC; argenx Announces Favorable Topline Results from Phase 3 ALKIVIA Study of Efgartigimod; Bristol Myers Squibb’s ZENBEXUS Receives U.S. FDA Accelerated Approval in Combination with Daratumumab and Dexamethasone for Multiple Myeloma; Zealand Pharma Secures USD 100 Million in Royalty Financing Through Agreement with Royalty Pharma for Rusfertide; PTC Advances Rare Disease Strategy with Acquisition of ST-920 Fabry Disease Program
AstraZeneca Ends eVOLVE-Lung02 Phase III Trial Evaluating Volrustomig Plus Chemotherapy AstraZeneca has decided to discontinue the Phase III eVOLVE-Lung02 trial, which was assessing volrustomig in combination with chemotherapy as a first-line treatment for patients with metastatic non-small cell lung cancer (mNS...
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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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