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ADARx doses first patient in Phase 3 STOP-HAE trial; ADX-324 receives orphan drug designation for hereditary angioedema

ADARx Pharmaceuticals, Inc. (ADARx), a late-stage clinical biotechnology company developing next-generation RNA therapeutics, today announced that the first patient has been dosed in its Phase 3 STOP-HAE clinical trial evaluating ADX-324 in...

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...

Illumina's Constellation Mapped Read technology uncovers hard-to-see genomic insights in the GeneDx pilot

Illumina, Inc. announced that GeneDx, a leader in genetic testing for rare diseases, is piloting Illumina's emerging constellation mapped read technology, evaluating its performance on regions of the genome that traditional short-read technologies...

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®...

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...

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....

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

CollPlant Biotechnologies a regenerative and aesthetic medicine company developing disruptive technologies and products based on its proprietary non-animal recombinant human collagen (rhCollagen), announced positive results from its non-clinical...

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)...

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

FORE Biotherapeutics, a registration stage biotherapeutics company dedicated to developing targeted therapies to treat patients with cancer, today presented new plixorafenib results from the previously completed Phase 1/2a clinical trial that...

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...

Waldencast announces the FDA approval of Obagi® saypha® MagIQ™ injectable hyaluronic acid gel under the Obagi Medical brand

Waldencast plc a global multi-brand beauty and wellness platform, announced that the U.S. Food and Drug Administration (“FDA”) has approved Obagi® saypha® MagIQ™ injectable hyaluronic acid (“HA”) gel, the first product in the Obagi® saypha®...

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...

Precision BioSciences announces a U.S. patent covering PBGENE-HBV for chronic hepatitis B and provides updates on the program's status

Precision BioSciences, Inc. a clinical stage gene editing company utilizing its novel proprietary ARCUS® platform to develop in vivo gene editing therapies for diseases with high unmet need, announced that it will be issued U.S. Patent No....

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...

Eisai submitted a rolling sBLA to the U.S. FDA for LEQEMBI® IQLIK™ as a subcutaneous starting dose to treat early Alzheimer’s, under Fast Track status

Eisai Co., Ltd. and Biogen Inc. announced that Eisai has initiated the rolling submission of the Supplemental Biologics License Application (sBLA) to the U.S. Food and Drug Administration (FDA) for lecanemab-irmb (U.S. brand name: LEQEMBI®)...

CorrectSequence Therapeutics' CS-101 Achieves Promising Results in First Patient: High-Precision Base Editing Clinical Treatment for Sickle Cell Disease

CorrectSequence Therapeutics Co., Ltd. (Correctseq), a clinical-stage biotechnology company pioneering transformer Base Editing (tBE) technology for the treatment of severe diseases, today announced the successful treatment of the first sickle...

2025 Interim Results and Business Updates Announced by Innovent

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

Innovent Biologics announces U.S. FDA IND approval for Phase 3 MarsLight-11 study of IBI363 in squamous NSCLC

Innovent Biologics, Inc. a world-class biopharmaceutical company committed to developing, manufacturing and commercializing high-quality medicines in oncology, cardiovascular and metabolic diseases, autoimmune, ophthalmology and other major...