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FDA Approves ZOLL’s Zenix Monitor/Defibrillator, Elevating Asahi Kasei’s Critical Care Solutions

in 1922 with ammonia and cellulose fiber business, Asahi Kasei has consistently grown through the proactive transformation of its business portfolio to meet the evolving needs of every age. With more than 50,000 employees worldwide, the company...

Shanchol® Oral Cholera Vaccine Prequalified by WHO, Ensuring Continuity of Global Supply

of Shanchol® have been supplied worldwide through UNICEF-led vaccination campaigns. After production was paused under its former ownership, GCBC Vaccines Pvt. Ltd. (formerly Shantha) has resumed manufacturing, with WHO conducting an on-site...

Pharmaceutical Leader Nia Tatsis, Ph.D., Appointed to Odyssey Therapeutics’ Board of Directors

Odyssey Therapeutics, Inc., a clinical-stage biopharmaceutical company seeking to transform the standard of care for patients suffering from autoimmune and inflammatory diseases by developing medicines that precisely target disease pathology,...

Dr. Zivjena Vucetic Appointed as Chief Medical Officer at Mission Bio to Lead Biopharma Partnerships and Clinical Adoption

as Chief Medical Officer. A physician-scientist with more than 15 years of experience in diagnostics and emerging platforms, Dr. Vucetic has directed medical and scientific strategies that move technologies from discovery to clinical settings,...

Therapeutics Complement Receives FDA IND Clearance to Advance CTx001 into Opti-GAIN, a Phase I/II Clinical Trial in Geographic Atrophy Secondary to AMD

enabling long-term modulation of the classical and alternative pathways of the complement cascade. GA is an advanced form of dry AMD that leads to irreversible vision loss, with limited therapeutic options currently available. "FDA clearance of the...

Zifo Executive: Biopharma Faces AI Anxiety and Tech Obsolescence

Despite the transformative potential of Artificial Intelligence, a pervasive 'AI anxiety' is holding back a significant portion of the biopharma industry, a worry that is directly linked to the need for a clear return on investment, according to...

Eisai and Biogen Announce U.S. Availability of LEQEMBI® IQLIK™ Subcutaneous Maintenance Dose for Early Alzheimer's Treatment

journey, the LEQEMBI Companion app was developed with Medisafe, a digital patient engagement and medication management platform. From educational information about the injection process to a tool for tracking where and when injections occur, the...

CareDx Announces IVD Products and IVDR Certification for AlloSeq® Tx and QTYPE®

of clinically differentiated, high-value healthcare solutions for transplant patients and caregivers. For more information, please visit www.caredx.com.

Niagen Bioscience's Pharmaceutical-Grade Niagen™ IV and Injections Are Now Available at Over 50 iCRYO Clinics and More Than 900 Clinics Nationwide

effective and efficient. With Niagen, we are equipping our franchisees and serving our guests with the very best.” Outperforming NAD+ IV in a pilot clinical study, Niagen IV offers superior tolerability, a 75% shorter infusion time (30-45 minute...

Novartis Receives FDA Approval for Rhapsido® (remibrutinib), the First Oral, Targeted BTKi Treatment for Chronic Spontaneous Urticaria (CSU

CSU across many countries, including in the European Union, Japan, and China, with priority review granted in China. Transforming care in Immunology "This approval of Rhapsido as the first and only BTK inhibitor in CSU is an important milestone in...

CollPlant Biotechnologies Announces Positive Non-Clinical Study Results for Its Photocurable Regenerative Dermal and Soft Tissue Filler

integrating contouring precision, structural support, and tissue regeneration into a single treatment. CollPlant's formulation combines hyaluronic acid with a modified form of rhCollagen to deliver both immediate and long-lasting benefits....

Corstasis Therapeutics and U.S. Heart and Vascular® will collaborate to improve heart failure care with ENBUMYST™ (Bumetanide Nasal Spray

heart failure, and hepatic and renal disease, including nephrotic syndrome in adults. INDICATION AND IMPORTANT SAFETY INFORMATION FOR ENBUMYST™ (BUMETANIDE NASAL SPRAY). INDICATION: ENBUMYST is indicated for the treatment of edema associated with...

Leqembi® has received approval for intravenous maintenance treatment in China

or the regimen of 10 mg/kg once every two weeks may be continued. AD is a progressive, relentless disease characterized by formation of protein deposits known as plaques made of amyloid-beta aggregates and neurofibrillary tangles made of tau...

At the Heart Failure Society of America, Bayer will showcase new data for KERENDIA® (finerenone)

with heart failure with left ventricular ejection fraction (HF LVEF) ≥40% (10mg, 20mg, 40mg tablets) IMPORTANT SAFETY INFORMATION CONTRAINDICATIONS: Hypersensitivity to any component of this product Concomitant use with strong CYP3A4 inhibitors...

Upsher-Smith Enhances Generics Portfolio by Introducing Difluprednate Ophthalmic Emulsion

improve patients' quality of life. By investing in talent, infrastructure, and biologics expansion, Bora continues to transform operations and achieve sustainable growth. For more information, please visit www.bora-corp.com.

European Commission Approves Alteogen’s Aflibercept Biosimilar, EYLUXVI® (ALT-L9)

long-acting therapeutic proteins and next-generation ADCs, developed by its proprietary NexP™-fusion and NexMab™ platform technology, respectively. It also developed a proprietary recombinant human hyaluronidase enzyme utilizing Hybrozyme™...

Sanguine Expands Oncology Biospecimen Portfolio via Strategic Clinic Partnerships

development, and potential therapeutic targets prior to intervention. Sanguine leverages its integrated technology platform to streamline data and donor engagement. By securely importing electronic medical records (EMRs) directly from clinic...

LOTUS study data on DAYBUE® (trofinetide) for Rett Syndrome's long-term efficacy and tolerability is published in Developmental Medicine and Child Neurology

has been shown to increase branching of dendrites and synaptic plasticity signals.10 Indication and Important Safety Information for DAYBUE® (trofinetide) Indication DAYBUE is indicated for the treatment of Rett syndrome in adults and pediatric...

Optune Lua® from Novocure has received approval in Japan for treating unresectable advanced/recurrent Non-Small Cell Lung Cancer (NSCLC)

balanced between cohorts: median age was 65 years (range, 22-86); 66% male, 34% female; 96% of patients had an ECOG performance status of 0-1. PD-L1 expression data were collected from 83% of patients (69 of 83 patients) enrolled at U.S. sites and...

At the American Thyroid Association meeting, FORE Biotherapeutics presented Phase 1/2a data for Plixorafenib, demonstrating a prolonged duration of effect in BRAF-altered thyroid cancers

FORTE basket study, which includes BRAF V600 altered thyroid cancers, as we aim to generate further data to inform treatment and help patients with BRAF driven tumors.” The results presented at ATA 2025 are from 21 patients with thyroid cancer, 16...