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Mar 04, 2026
Scholar Rock plans to resubmit its biologics license application for apitegromab in spinal muscular atrophy following FDA reinspection of the Catalent Indiana fill-finish facility, with a U.S. launch anticipated in 2026.
Mar 03, 2026
The FDA informed uniQure that Phase 1/2 study data for AMT-130 in Huntington's disease is insufficient to support a biologics license application, recommending a prospective, randomized, double-blind, sham surgery-controlled study instead.
Mar 03, 2026
The FDA issued a Complete Response Letter for Atara Biotherapeutics' Ebvallo application, reversing its prior acceptance of the ALLELE trial design. Partner Pierre Fabre Pharmaceuticals has requested a Type A meeting to address the agency's concerns.
Mar 03, 2026
The AI in genomics market is estimated to grow from USD 1.97 billion in 2026 to USD 317.4 billion by 2040, while the drug discovery informatics market is expected to reach USD 11.18 billion by 2035, driven by machine learning integration and big data analytics.
Mar 03, 2026
The global oncology market is projected to nearly triple from $279.98 billion in 2026 to $748.17 billion by 2035, driven by rapid adoption of immunotherapy, checkpoint inhibitors, and cell therapies across solid tumors and hematologic cancers.
Mar 03, 2026
Sanofi's oral BTK inhibitor rilzabrutinib received orphan drug designation in Japan for IgG4-related disease and warm autoimmune hemolytic anemia, while also securing U.S. FDA breakthrough therapy designation for the rare anemia indication.
Mar 03, 2026
New initiatives aim to address social determinants of health in oncology, while research reveals persistent disparities in treatment access and clinical trial participation for Black and minority cancer patients.
Mar 03, 2026
Xbrane Biopharma reported full year 2025 revenue of SEK 152.4 million and a profit of SEK 127.2 million, driven by a SEK 168.9 million gain from the Alvotech transaction. The FDA issued a Complete Response Letter for the company's ranibizumab biosimilar application in October.
Mar 03, 2026
uniQure reports Q4 2025 results as investors await clarity on AMT-130 Huntington's disease gene therapy following FDA's November indication that Phase I/II data unlikely to support biologics license application.
Mar 03, 2026
Bristol Myers Squibb's growth portfolio increased 17% in 2025, partially offsetting a 15% decline in legacy products facing generic competition. The company's stock gained 11.4% in the past month on strong fourth-quarter results.
Mar 03, 2026
Polaryx Therapeutics has selected a contract research organization to conduct SOTERIA, a phase 2 trial evaluating PLX-200 across four rare lysosomal storage disorders, with trial initiation planned for the first half of 2026.
Mar 03, 2026
The European Medicines Agency's Committee for Medicinal Products for Human Use has adopted a positive opinion recommending marketing authorization for Moderna's mCOMBRIAX, the world's first combination Covid-19 and influenza vaccine, for individuals 50 years and older.
Mar 02, 2026
The FDA has accepted New Drug Applications for rusfertide in polycythemia vera with Priority Review and tirabrutinib for relapsed/refractory primary CNS lymphoma under Accelerated Approval, with PDUFA dates set for Q3 2026 and December 2026 respectively.
Mar 03, 2026
Relay Therapeutics reported full-year 2025 revenue of $15.36 million and a narrowed net loss of $276.48 million, while securing FDA Breakthrough Therapy designation for lead asset zovegalisib. The company filed a $96.18 million shelf registration.
Mar 02, 2026
The FDA removed the clinical hold on Intellia Therapeutics' Phase 3 trial of nexiguran ziclumeran for transthyretin amyloidosis with cardiomyopathy. The hold was imposed in October following liver safety concerns in one patient.
Mar 02, 2026
Final analysis of Merck's Phase 3 KEYNOTE-B96 trial shows KEYTRUDA plus paclitaxel with or without bevacizumab significantly improved overall survival in platinum-resistant recurrent ovarian cancer patients, reducing death risk by 18%.
Mar 02, 2026
Canada's Drug Agency issued a draft recommendation against public drug plan coverage for lecanemab, an Alzheimer's treatment conditionally approved by Health Canada in October 2025, citing cost concerns despite the drug's ability to slow cognitive decline.
Mar 02, 2026
The FDA has accepted Regeneron's Biologics License Application for garetosmab to treat fibrodysplasia ossificans progressiva, granting Priority Review with a target action date of August 2026. The application is supported by Phase 3 OPTIMA trial data.
Mar 02, 2026
The pharmaceutical industry is experiencing recovery driven by innovation in drug development, aggressive M&A activity, and expansion of drug development services. The sector faces both opportunities and headwinds including pipeline setbacks and regulatory pressures.
Mar 02, 2026
Belite Bio announced preliminary Q4 2025 results and plans to submit an NDA for tinlarebant in Q2 2026 following positive Phase 3 trial results. BioArctic reported record financial results with operating profit exceeding SEK 1.2 billion for 2025. Recordati delivered strong preliminary full-year 2025 results despite FX headwinds.
