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Approval and Launch of Nintedanib Capsules

Dexcel Pharma USA is pleased to announce that it has received final approval from the U.S. Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA) for Nintedanib Capsules, 100 mg and 150 mg, the generic equivalent of...

CellCentric Launches DOMMINO-1, a Phase 2 Trial of Inobrodib Combined with Pomalidomide and Dexamethasone in Relapsed/Refractory Multiple Myeloma

CellCentric, a clinical-stage biotechnology company developing inobrodib as a first-in-a-class, oral p300/CBP inhibitor for the treatment of multiple myeloma, announced the initiation of DOMMINO-1, a pivotal Phase 2 clinical trial evaluating...

ProductLife Group Appoints Dr. James Burt as CEO

ProductLife Group (PLG), a global provider of consulting and outsourcing services for the life sciences industry, has appointed Dr. James Burt as Chief Executive Officer. Dr. Burt brings more than 20 years of international leadership experience...

Constance Sabbagh Appointed as General Manager as Avanzanite Expands French Operations

Avanzanite Bioscience B.V., a rapidly growing commercial-stage European specialty pharmaceutical company focused on rare diseases, today announced its expansion into France, Europe’s second largest economy, and the appointment of Constance Sabbagh...

FTC Warns PBM Practices Drive Higher Drug Costs as Employers Push Back

US-Rx Care, the nation's first fiduciary pharmacy risk manager and an industry leader since 2007, is issuing an urgent strategic call-out to employers: the Pharmacy Benefit Manager (PBM) industry has reached a point of no return. After years of...

30% Lower Risk With WELIREG® + LENVIMA® vs. Cabozantinib in Previously Treated RCC

Merck known as MSD outside of the United States and Canada, and Eisai today announced the first presentation of results from the Phase 3 LITESPARK-011 trial evaluating the dual oral regimen of WELIREG® (belzutifan). Merck’s first-in-class oral...

CollPlant Expands Its rhCollagen 3D Bioprinting Portfolio Through the Launch of Ready-to-Print BioFlex

CollPlant a regenerative and aesthetic medicine company developing innovative technologies and products based on its proprietary recombinant human collagen (rhCollagen) platform, today announced the launch of BioFlex, a ready-to-print...

SECuRE trial update: Another participant with negative PSMA PET and undetectable PSA

Clarity Pharmaceuticals a clinical-stage radiopharmaceutical company with a mission to develop next-generation products that improve treatment outcomes for patients with cancer, is pleased to announce that yet another participant with mCRPC in the...

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...

To strengthen global AI, data strategy, evidence synthesis, and economic modelling capabilities, Precision AQ expands its senior leadership team

Precision AQ, a global commercialisation partner built to guide life science innovators through commercial complexity, announced the appointment of two new leaders who will accelerate the company's international growth and enhance delivery of...

FDA Grants KORU Medical Systems 510(k) Clearance for RYSTIGGO® Delivery via FreedomEDGE® Infusion System

KORU Medical Systems, Inc. a leading medical technology company focused on the development, manufacturing, and commercialization of innovative and patient-centric large volume subcutaneous infusion solutions, announced that the Company received...

Ad Hoc Analyses Indicate Enhanced Survival Outcomes with VYLOY™ (zolbetuximab) Combined with Chemotherapy When Common Adverse Events Are Properly Managed

Astellas Pharma U.S., Inc. announced the publication of exploratory ad hoc analyses from the combined Phase 3 SPOTLIGHT (NCT03504397) and GLOW (NCT03653507) studies in patients with HER2-negative, CLDN18.2-positive advanced gastric or...

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...

RoslinCT and BOOST Pharma Form Strategic Manufacturing Partnership to Advance Cell Therapy for Osteogenesis Imperfecta

RoslinCT, a global contract development and manufacturing organization (CDMO) specializing in advanced cell therapies, and BOOST Pharma, a clinical-stage biotechnology company developing first-in-class cell therapies for rare paediatric skeletal...

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

Eisai Co., Ltd. and Biogen Inc. (Nasdaq: BIIB, Corporate headquarters: Cambridge, Massachusetts, CEO: Christopher A. Viehbacher, "Biogen") announced that Eisai has completed the rolling submission of the Supplemental Biologics License Application...

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).

Arrowhead Pharmaceuticals, Inc. announced that the U.S. Food and Drug Administration (FDA) has approved REDEMPLO (plozasiran), a small interfering RNA (siRNA) medicine, as an adjunct to diet to reduce triglycerides in adults with familial...

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...