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🇺🇸 AmericasLatest pharmaceutical news, drug approvals, and FDA regulatory updates
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Emergent BioSolutions Partners with Substipharm for $34.5M Japanese Encephalitis Vaccine Manufacturing Deal
Emergent BioSolutions announces $34.5M partnership with Substipharm Biologics to manufacture IMOJEV Japanese encephalitis vaccine for U.S. government distribution.
Cordis Launches SELUTION SLR Drug-Eluting Balloon in Japan for Peripheral Artery Disease Treatment
Cordis introduces SELUTION SLR PTA Drug-Eluting Balloon in Japan, offering new treatment option for peripheral artery disease patients with proven clinical outcomes.
Zealand Pharma's Survodutide Achieves 16.6% Weight Loss in Phase 3 Obesity Trial, Outperforming Current GLP-1 Therapies
Zealand Pharma announces survodutide achieved 16.6% weight loss in Phase 3 SYNCHRONIZE-1 trial, potentially exceeding Wegovy and Zepbound efficacy rates.
Ashvattha Therapeutics Presents Migaldendranib Data for Diabetic Macular Edema and AMD Treatment
Ashvattha Therapeutics announces presentations on Migaldendranib's mechanism of action for treating diabetic macular edema and neovascular AMD via subcutaneous delivery.
Aclaris Therapeutics ATI-052 Shows Promising 45-Day Half-Life in Phase 1a Trial Results
Aclaris Therapeutics announces positive Phase 1a results for ATI-052, a first-in-class anti-TSLP/IL-4Rα bispecific antibody with 45-day half-life for Th2 diseases.
Trevi Therapeutics Schedules Q1 2026 Earnings Call for Haduvio Chronic Cough Treatment Updates
Trevi Therapeutics will report Q1 2026 financial results and provide corporate updates on Haduvio development for chronic cough treatment on May 5, 2026.
Soligenix HyBryte Phase 3 FLASH2 Trial Shows Interim Results for Cutaneous T-Cell Lymphoma Treatment
Soligenix announces interim efficacy analysis results from Phase 3 FLASH2 trial evaluating HyBryte for cutaneous T-cell lymphoma treatment.
Avicanna Welcomes U.S. Cannabis Rescheduling Decision, Advances Medical Cannabis R&D Strategy
Avicanna Inc. applauds U.S. medical cannabis rescheduling announcement, supporting the company's pharmaceutical strategy and clinical development initiatives.
InnoCare Pharma Begins Phase III Trial of Orelabrutinib for Systemic Lupus Erythematosus Treatment
InnoCare Pharma doses first patient in Phase III trial testing BTK inhibitor orelabrutinib for systemic lupus erythematosus, marking key milestone.
Orca Bio's Orca-Q Receives FDA RMAT Designation for High-Risk Blood Cancers Treatment
Orca Bio's Orca-Q therapy gains FDA RMAT designation for high-risk hematologic malignancies based on promising Phase 1 survival and safety data.
FormBlends Releases 2026 Peptide Report as RFK-Era HHS Reshapes GLP-1 Therapy Access
FormBlends' 2026 State of Peptides report analyzes how RFK Jr.'s HHS and new obesity drugs from major pharma are changing GLP-1 therapy access for Americans.
C-Ray Therapeutics Receives FDA Acceptance for Copper-64 Drug Master File, Advancing Radiopharmaceutical Development
C-Ray Therapeutics' Copper-64 Drug Master File receives FDA acceptance, enabling global radiopharmaceutical developers to reference DMF No. 43568 for submissions.
BRC Therapeutics Receives FDA Clearance for BRC-002 Phase I Trial in Complex Regional Pain Syndrome
BRC Therapeutics gets FDA IND clearance for BRC-002, a first-in-class treatment for Complex Regional Pain Syndrome, advancing to Phase I safety trials.
Vanda Pharmaceuticals' Imsidolimab Shows Efficacy for Generalized Pustular Psoriasis in NEJM Evidence Study
Vanda Pharmaceuticals announces publication of pivotal Phase III imsidolimab study for generalized pustular psoriasis in NEJM Evidence, supporting BLA submission.
AstraZeneca's BREZTRI Aerosphere Approved as First Triple Therapy for Asthma in Patients 12 and Older
AstraZeneca receives FDA approval for BREZTRI Aerosphere as the first and only triple-combination therapy for asthma maintenance treatment in patients aged 12+.
Vensica Medical Receives FDA IND Approval for Phase 2 Trial of ViXe Needle-Free Xeomin Delivery System
Vensica Medical gets FDA clearance to begin Phase 2 trials for ViXe, a needle-free delivery system for Xeomin treatment of overactive bladder syndrome.
AbbVie Submits FDA Application for Upadacitinib (RINVOQ) to Treat Severe Alopecia Areata
AbbVie submits FDA application for upadacitinib (RINVOQ) to treat severe alopecia areata in adults and adolescents, backed by Phase 3 trial data.
Novartis Reports Strong Q1 2026 Growth Led by Remibrutinib CHMP Approval and Pipeline Advances
Novartis delivers strong Q1 2026 growth with Remibrutinib receiving positive CHMP opinion for chronic spontaneous urticaria and multiple pipeline milestones.
Wave Life Sciences WVE-007 Phase 2a Trial Gets FDA Approval for Obesity and Type 2 Diabetes Treatment
Wave Life Sciences receives FDA acceptance for WVE-007 Phase 2a multidose trial targeting obesity and type 2 diabetes, set to begin Q2 2026.
Pharma Partnering US: Emergent, EvolveImmune Deals Emerge
While direct announcements from the Pharma Partnering US 2026 event were not found, recent strategic manufacturing partnerships and collaborations emphasizing US operations have been reported. Key deals involve Emergent BioSolutions, EvolveImmune Therapeutics, and PTC Therapeutics.