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Made Scientific and Sentinel BioTherapeutics Announce a Strategic Manufacturing Partnership to Advance the Phase I/II Allogeneic ePP Encapsulated Cell Therapy Program

Made Scientific, a leading U.S.-based cell therapy contract development and manufacturing organization (CDMO), and Sentinel BioTherapeutics, a clinical-stage biotechnology company advancing encapsulated cell-based immunotherapies for solid tumors,...

Phase 1/2 Clinical Study of Novel EGFR/HER3 Bispecific Antibody-Drug Conjugate AVZO-1418/DB-1418 Begins with First Patient Dosed

Duality Biotherapeutics' partner Avenzo Therapeutics, Inc. ("Avenzo"), a clinical-stage biotechnology company developing next-generation oncology therapies, announced the first patient has been dosed in the Phase 1 portion of a Phase 1/2 clinical...

Innovent Announces Approval from China's NMPA for Mazdutide, the First Dual GCG/GLP-1 Receptor Agonist, for Chronic Weight Management

Innovent Biologics, Inc. a world-class biopharmaceutical company that develops, manufactures and commercializes high-quality medicines for the treatment of oncologic, autoimmune, cardiovascular and metabolic, ophthalmologic and other major...

enGene’s Detalimogene Receives RMAT Designation from the FDA, Opening the Path for Expedited Review in High-Risk, Non-Muscle Invasive Bladder Cancer

enGene Holdings Inc. a clinical-stage, non-viral gene-based immunotherapy company, announced that the U.S. Food and Drug Administration (FDA) has granted Regenerative Medicine Advanced Therapy (RMAT) designation to detalimogene voraplasmid (also...

Nuvation Bio’s IBTROZI™ (taletrectinib), a next-generation oral treatment for advanced ROS1-positive non-small cell lung cancer, has been approved by the U.S. Food and Drug Administration

Nuvation Bio Inc. a global oncology company focused on tackling some of the toughest challenges in cancer treatment, announced that the U.S. Food and Drug Administration (FDA) has approved IBTROZI™ (taletrectinib) for the treatment of adult...

Lubrizol reveals a significant milestone for its innovative, patented Apisolex™ polymer excipient

Lubrizol announces that an Apisolex™ polymer excipient-enabled drug formulation is in Phase 1 clinical trials. Introduced to the market in 2022, Apisolex polymer excipient is a polyamino acid-based polymer that enhances the solubility of BCS Class...

Otulfi® (ustekinumab-aauz) by Fresenius Kabi Now FDA-Approved as an Interchangeable Biosimilar

Fresenius Kabi, an operating company of Fresenius, and Formycon AG, announced that the U.S. Food and Drug Administration (FDA) designated Otulfi® (ustekinumab-aauz) as an interchangeable biosimilar to the reference product Stelara® (ustekinumab)....

Rein Therapeutics announces the initiation of the RENEW Phase 2 trial of LTI-03 in patients with IPF

Rein Therapeutics a biopharmaceutical company advancing a novel pipeline of first-in-class medicines to address significant unmet medical needs in orphan pulmonary and fibrosis indications, announced that the RENEW Phase 2 trial of its lead asset,...

Serge Messerlian Appointed CEO of Creyon Bio, Leveraging Decades of Experience in Company Building and Strategic Collaborations

Creyon Bio, Inc. announced the appointment of industry leader, Serge Messerlian as Chief Executive Officer, effective immediately. Mr. Messerlian brings Creyon Bio a track record in both multinational pharmaceutical and biotechnology leadership as...

HighField Biopharmaceuticals Files INDs for Two ADCplex™ Immunoliposomes with Distinct Payloads to Address Limitations of Current ADCs

HighField Biopharmaceuticals, a clinical stage company using lipid-based therapeutics to treat cancer and other diseases, announced today it has filed two investigational new drug (IND) applications (HF158K1 and HFK2) with China’s National Medical...

Exicure, Inc. (Nasdaq: XCUR) Unveils Next Steps Toward New Clinical Trial in Acute Myeloid Leukemia (AML)

Exicure, Inc. today shared updates on its lead asset, GPC-100 (burixafor), a small molecule CXCR4 inhibitor. Exicure, Inc. (“Exicure”) is planning for a clinical trial in Acute Myeloid Leukemia (AML) with GPC-100. The company believes that...

IRBM Expands Functional Genomics Platform for Early Drug Discovery

IRBM, an integrated Contract Research Organization (CRO) specializing in preclinical drug discovery, has established a comprehensive Functional Genomics Platform to support genetic target identification and validation, and generation of...

ELIQUENT Life Sciences Acquires Truliant Consulting, Expanding Pharmacovigilance Platform

ELIQUENT Life Sciences (ELIQUENT), a global regulatory, quality, and safety consulting firm, today announced the acquisition of Truliant Consulting (Truliant), a leading pharmacovigilance, risk management, and regulatory compliance advisory firm....

Developing innovative production technology for the commercialization of 3D cell products, PHC and Cyfuse collaborate

PHC Corporation a subsidiary of PHC Holdings Corporation (Headquarters: Chiyoda-ku, Tokyo; President: Kyoko Deguchi), and Cyfuse Biomedical K.K. announce the successful development of a new production technology(*1) for the commercialization of...

Actinium Pharmaceuticals publishes Actimab-A + CLAG-M trial results for relapsed/refractory AML in Leukemia

Actinium Pharmaceuticals, Inc. a pioneer in the development of targeted radiotherapies, announced that results from the clinical trial evaluating Actimab-A in combination with the chemotherapy CLAG-M in patients with relapsed/refractory acute...

Fzata secures a clinical trial agreement for FZ002, targeting C. difficile treatment.

Fzata, Inc. announces the execution of a clinical trial agreement with the National Institutes of Health (NIH) to sponsor a Phase 1 clinical trial of FZ002 for C. difficile treatment. Oral FZ002 is a live yeast genetically modified to express a...

Redefining Pharmaceutical Market Analytics and Insights: PharmaScroll

PharmaScroll, a premier market research and business analytics firm, continues to set the benchmark for excellence in supporting the global life sciences and healthcare organizations. Renowned for its innovative tech-based solutions and in-depth...

Beacon Therapeutics has been granted FDA Regenerative Medicine Advanced Therapy (RMAT) designation for laru-zova (AGTC-501)

Beacon Therapeutics Holdings Limited a leading ophthalmic gene therapy company with a mission to save and restore the vision of patients with blinding retinal diseases, announced that the U.S. Food and Drug Administration (FDA) has granted...

Lutris Pharma secures $30 million in financing to advance the development of a biopharmaceutical aimed at improving the effectiveness of anti-cancer drugs

Lutris Pharma, a clinical stage biopharmaceutical company focused on improving anti-cancer therapies by reducing cutaneous dose-limiting toxicity, announced that it has secured a $30 million financing to advance the development of LUT014, an...

Artax Biopharma validates AX-158, a first-in-class oral Nck modulator, in phase 2a for autoimmune disease

Artax Biopharma, Inc., a clinical-stage biotechnology company focused on transforming the treatment of autoimmune diseases, today announces achievement of clinical validation through its Phase 2a clinical trial in psoriasis with fully proprietary...

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