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FIZE Medical, in an exclusive deal with Asahi Kasei Medical, has launched the FIZE kUO® System in Japan

global expansion and reinforces its mission to bring real-time kidney data into clinical decision-making. By transforming urine output into a continuously measured and analysed digital parameter, FIZE enables clinicians to better assess kidney...

GMA with MOVIVA®: Setting New Standards in Endoscopic Bariatric Treatment.

Agostino Gemelli in Rome, clinical experience is rapidly expanding across Europe. With around 80 procedures performed within a short timeframe in eight countries, MOVIVA® is helping to establish a new era of endoscopic bariatric treatment –...

Health Canada has granted Celltrion approval for Eydenzelt®, a biosimilar referencing Eylea® (aflibercept 2mg).

Canada has approved Eydenzelt®, a biosimilar referencing Eylea® (aflibercept 2mg), in both vial and pre-filled syringe format, for treatment of all indications approved for Eylea. “Today’s approval lays a solid foundation for Celltrion’s expansion...

Samsung Bioepis Announces the Launch of Denosumab Biosimilars, OBODENCE™ and XBRYK™, in Europe

denosumab-containing medicinal products Hypercalcaemia in paediatric patients These highlights do not include all the information needed to use OBODENCE safely and effectively. Refer to the Summary of Product Characteristics for OBODENCE’s full...

Menarini Group Shares New Data on ELZONRIS® (tagraxofusp-erzs)

and Stemline Therapeutics, Inc. ("Stemline"), a wholly-owned subsidiary of the Menarini Group, focused on bringing transformational oncology treatments to cancer patients, announced that the company will present new data related to ELZONRIS®...

Eisai Completes FDA Submission for LEQEMBI® IQLIK™ Subcutaneous Starting Dose.

entire treatment journey. The injection time for each LEQEMBI IQLIK autoinjector takes approximately 15 seconds. The SC formulation also has the potential to reduce healthcare resources associated with IV dosing, such as preparation for infusion...

VahatiCor Closes Oversubscribed Series B Financing to Speed Up A-FLUX® Development for Coronary Microvascular Dysfunction

VahatiCor, a medtech company transforming cardiac care for Coronary Microvascular Dysfunction (CMD), announced the successful closing of its $23 million Series B financing led by S3 Ventures, with support from Intuitive Ventures, and a strategic...

FDA Approves Arrowhead Pharmaceuticals’ REDEMPLO® (plozasiran) for Reducing Triglycerides in Adults with Familial Chylomicronemia Syndrome (FCS).

injection once every three months. REDEMPLO utilizes the proprietary and differentiated Targeted RNAi Molecule (TRiM™) platform and is Arrowhead’s first FDA-approved medicine, marking a major milestone for the company as it transitions into...

Emulate, in Partnership with FUJIFILM Cellular Dynamics, Launches Brain-Chip R1 to Advance Neurological Drug Development

Emulate Brain-Chip R1. This first-in-class isogenic model of the neurovascular unit offers researchers a powerful new platform for studying drug transport across the blood-brain barrier (BBB) and investigating mechanisms of neuroinflammation. The...

Jazz Pharmaceuticals presents new clinical and translational data for Modeyso™ (dordaviprone) in H3 K27M-mutant diffuse midline glioma at SNO 2025

clinical and preclinical research evaluating Modeyso™ (dordaviprone), as well as new preclinical data featuring JZP3507 (formerly ONC206) in central nervous system (CNS) tumors, reflecting Jazz's growing impact and innovation in neuro-oncology. Key...

New long-term data confirms TREMFYA® (guselkumab) as the only IL-23 inhibitor proven to block joint damage in active psoriatic arthritis

What are the possible side effects of TREMFYA®? TREMFYA® may cause serious side effects. See "What is the most important information I should know about TREMFYA®?" The most common side effects of TREMFYA® include: respiratory tract infections,...

Marius Pharmaceuticals has expanded its global footprint with Health Canada’s approval of KYZATREX® (testosterone undecanoate) CIII capsules

the U.S. market and makes the only oral testosterone replacement therapy option available under a softgel capsule dosage form in Canada. Building on Marius’s earlier submission to Health Canada in July 2024, the company is now poised to provide...

The BioTech Breakthrough Award has been granted to Asahi Kasei for the Planova™ FG1 Filter

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...

Odyssey Therapeutics Welcomes Dennis Dean, Ph.D., as EVP, Non-Clinical Development

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,...

HanchorBio Unveils Compelling New Data at SITC 2025 Highlighting the Best-in-Class Potential of HCB101 in Advanced Cancers

for HCB301, a tri-specific fusion targeting SIRPα/CD47, PD-1/PD-L1, and TGFβ, reinforces the scientific breadth of our platform across innate and adaptive immunity," said Scott Liu, Ph.D., Founder, Chairman, and CEO of HanchorBio. "HCB101 was...

Gilead’s Livdelzi® Shows Sustained Efficacy in PBC, Reducing ALP, Relieving Itch, and Potentially Slowing Disease Progression

in those at highest risk. This reinforces our belief in Livdelzi’s treatment profile and its potential to help transform care for people living with PBC. At Gilead, we remain focused on delivering innovation that drives long-term impact for...

PRM Pharma Launches HemiClor® 12.5 mg, the First FDA-Approved Low-Dose Chlorthalidone Tablet for Hypertension

the nationwide availability of HemiClor® (chlorthalidone) 12.5 mg tablets, the first and only FDA-approved 12.5 mg formulation of chlorthalidone for the treatment of hypertension in adults. This milestone comes as the newly released 2025 AHA/ACC...

Leukogene Therapeutics’ M2T-CD33 (LTI-214) has received Orphan Drug Designation from the U.S. FDA for the treatment of Acute Myeloid Leukemia

that are both potent and safer for patients. This designation represents an important step toward our goal of transforming the treatment paradigm for AML.” Nathan Dolloff, PhD, Founder and CSO of Leukogene stated, “This is an important step forward...

LIfT BioSciences will present preclinical data on its first-in-class Immunomodulatory Alpha Neutrophils at the 40th Society for Immunotherapy of Cancer

of LIfT BioSciences, commented: “Being selected to present our latest data underscores growing recognition of our IMAN platform’s potential to transform immuno-oncology. Our findings highlight how our first-in-class IMANs can restore innate immune...

Data on BIMZELX® (bimekizumab-bkzx) in Hidradenitis Suppurativa Showed Sustained Improvements in Pain and Draining Tunnel Resolution for Three Years

a global biopharmaceutical company focused on the discovery and development of innovative medicines and solutions to transform the lives of people living with severe diseases of the immune system or of the central nervous system. With approximately...