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PureTech Secures U.S. and EU Orphan Designations for Deupirfenidone (LYT-100) in IPF

PureTech Health plc a hub-and-spoke biotherapeutics company dedicated to giving life to science and transforming innovation into value, announced that the U.S. Food and Drug Administration (FDA) and European Commission have granted Orphan Drug...

MTF Biologics and Kolosis BIO introduce Summit Matrix™, expanding solutions for orthopedic and spinal surgeries

MTF Biologics, a global nonprofit organization that saves and heals lives by advancing tissue and organ donation, transplantation, and research, and Kolosis BIO (Kolosis), a premier provider of orthobiologic solutions, announced the launch of...

FDA Approves New 2-Gram Fibryga® Presentation to Improve Convenience and Precision in Treating Acquired Fibrinogen Deficiency

Octapharma USA, Inc. announced that the U.S. Food and Drug Administration (FDA) has approved a new 2-gram presentation of Fibryga®, Fibrinogen (Human) Lyophilized Powder for Reconstitution, for fibrinogen replacement in patients with acquired...

Orum Therapeutics Names Chad May Chief Scientific Officer to Advance Degrader-Antibody Conjugate Programs

Orum Therapeutics a biotechnology company pioneering the field of degrader-antibody conjugates (DACs), today announced the appointment of Chad May, Ph.D., as Chief Scientific Officer (CSO). Dr. May brings more than 20 years of oncology and...

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

Just a few months after the world’s first Gastric Mucosal Ablation (GMA) case using MOVIVA® at the Policlinico Universitario Agostino Gemelli in Rome, clinical experience is rapidly expanding across Europe. With around 80 procedures performed...

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

Jazz Pharmaceuticals plc announced that the company will present five abstracts at the 2025 Society for Neuro-Oncology (SNO) Annual Meeting taking place November 19-23 in Honolulu, Hawaii. The presentations will feature both clinical and...

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

Johnson & Johnson announced new data from the Phase 3b APEX study showing that TREMFYA® continued to reduce both signs and symptoms of active psoriatic arthritis (PsA) and inhibit progression of structural damage at 48 weeks. At Week 24, TREMFYA ®...

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

Asahi Kasei Corporation has earned top honors in the 2025 BioTech Breakthrough Awards, winning the Biomanufacturing Innovation of the Year for its Planova™ FG1 virus removal filter, developed by its Asahi Kasei Bioprocess business unit. Designed...

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

Gilead Sciences, Inc. announced new long-term data reinforcing the safety and efficacy profile of Livdelzi® (seladelpar) for people living with primary biliary cholangitis (PBC). Findings support Livdelzi's consistent efficacy and safety outcomes...

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

UCB, a global biopharmaceutical company, announced three-year data from the BE HEARD trials for BIMZELX® (bimekizumab-bkzx) in moderate-to-severe hidradenitis suppurativa (HS). BIMZELX, the first and only medicine approved to selectively inhibit...

Baird Medical’s MWA system has achieved successful Medicare reimbursement at a prominent New York practice

Merck known as MSD outside of the United States and Canada, announced positive topline results from the Phase 3 LITESPARK-022 trial in patients with clear cell renal cell carcinoma (RCC) following nephrectomy. In this study, KEYTRUDA®...

Successfully deployed in Myanmar conflict zone, the SurgiField system enables life-saving surgery

SurgiBox Inc. announced the successful deployment of its SurgiField System in Myanmar (Burma), where frontline medical teams used the portable surgical technology to perform life-saving procedures in active conflict zones. In a breakthrough...

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

Asahi Kasei, a global provider of healthcare technology and pharmaceutical solutions, has advanced its suite of critical care products through premarket approval by the U.S. Food and Drug Administration (FDA) for ZOLL’s Zenix®...

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

Novartis announced that Rhapsido® (remibrutinib) received US Food and Drug Administration (FDA) approval as an oral treatment for adult patients with chronic spontaneous urticaria (CSU) who remain symptomatic despite H1 antihistamine treatment....

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

Corstasis Therapeutics Inc., an innovative biopharmaceutical company providing enhanced outpatient therapeutic options for patients with cardiovascular and renal disease, announced a strategic collaboration with U.S. Heart and Vascular® (USHV),...

Leqembi® has received approval for intravenous maintenance treatment in China

BioArctic AB's partner Eisai announced that lecanemab (Leqembi) has been approved for once every four weeks intravenous (IV) maintenance dosing for the treatment of early Alzheimer's disease by the National Medical Products Administration (NMPA)...

Upsher-Smith Enhances Generics Portfolio by Introducing Difluprednate Ophthalmic Emulsion

Upsher-Smith Laboratories, LLC announced the recent launch of Difluprednate Ophthalmic Emulsion 0.05%. According to IQVIA, the Difluprednate Ophthalmic Emulsion market had U.S. sales of approximately $18 million*. The Therapeutic Equivalence (TE)...

Medicines Discovery Catapult and Crown Bioscience form a global alliance for radiopharmaceutical innovation

Medicines Discovery Catapult (MDC) and Crown Bioscience have formed a strategic global collaboration to deliver an integrated translational biology platform for innovators developing radiopharmaceuticals. Radiopharmaceuticals are a growing class...

Nuvation Bio unveils new data on IBTROZI™ (taletrectinib) in advanced ROS1-positive non-small cell lung cancer

Nuvation Bio Inc. a global oncology company focused on tackling some of the toughest challenges in cancer treatment, announced new and updated results from the pivotal Phase 2 TRUST-I and TRUST-II studies evaluating IBTROZI™ (taletrectinib) for...

Boehringer Ingelheim launches swine vaccine with advanced protection against Porcine Circovirus Type 2 in the U.S

Launching now in the U.S., INGELVAC CIRCOFLEX® AD is the first vaccine to combine both PCV2a and PCV2d antigens in a single dose designed for optimized herd health. Built on the industry-leading vaccine INGELVAC CIRCOFLEX® from Boehringer...