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CareDx Announces IVD Products and IVDR Certification for AlloSeq® Tx and QTYPE®

CareDx, Inc. – The Transplant Company™ – a leading precision medicine company focused on the discovery, development, and commercialization of clinically differentiated, high-value healthcare solutions for transplant patients and caregivers – The...

Niagen Bioscience's Pharmaceutical-Grade Niagen™ IV and Injections Are Now Available at Over 50 iCRYO Clinics and More Than 900 Clinics Nationwide

Niagen Bioscience, Inc. the global authority on NAD+ (nicotinamide adenine dinucleotide) with a focus on the science of healthy aging, announces that pharmaceutical-grade Niagen Plus™ products, Niagen IV and injections, are now offered at more...

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)...

At the Heart Failure Society of America, Bayer will showcase new data for KERENDIA® (finerenone)

Bayer announced that data from across the KERENDIA® (finerenone) comprehensive clinical trial program will be presented at the Heart Failure Society of America (HFSA)’s. In July 2025, the U.S. Food and Drug Administration (FDA) approved a new...

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)...

European Commission Approves Alteogen’s Aflibercept Biosimilar, EYLUXVI® (ALT-L9)

Alteogen Inc. announced today that the European Commission (EC) has granted marketing authorization for EYLUXVI® (code name: ALT-L9), an Eylea® biosimilar co-developed by its subsidiary, Alteogen Biologics. EYLUXVI® is Alteogen's second approved...

Sanguine Expands Oncology Biospecimen Portfolio via Strategic Clinic Partnerships

Sanguine Biosciences, a leading provider of healthy and disease-state human biospecimens and data for research, today announced the expansion of its oncology sample offerings through new partnerships with oncology clinics nationwide. These...

LOTUS study data on DAYBUE® (trofinetide) for Rett Syndrome's long-term efficacy and tolerability is published in Developmental Medicine and Child Neurology

Acadia Pharmaceuticals Inc. announced that the journal Developmental Medicine and Child Neurology published interim results from the caregiver-reported observational online, open-label, ongoing LOTUS study evaluating effectiveness and tolerability...

Optune Lua® from Novocure has received approval in Japan for treating unresectable advanced/recurrent Non-Small Cell Lung Cancer (NSCLC)

Novocure announced that Japan’s Ministry of Health, Labour and Welfare (MHLW) approved Optune Lua® for concurrent use with PD-1/PD-L1 inhibitors for the treatment of adult patients with unresectable advanced/recurrent non-small cell lung cancer...

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...

At the PHPN 2025 Symposium, Corsair Pharma will present new data on its proprietary transdermal system for Treprostinil prodrug

Corsair Pharma, Inc., a clinical-stage biopharmaceutical company focused on advancing innovative transdermal therapies for pulmonary arterial hypertension (PAH), today announced it will present new data on the TRX-248 Transdermal System at the...

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...

Marius Pharmaceuticals and Hims & Hers™ collaborate to expand access to KYZATREX® (testosterone undecanoate) CIII capsules, the first FDA-approved oral testosterone therapy available on the Hims & Hers platform

Marius Pharmaceuticals, Inc. announced a collaboration with Hims & Hers™, one of the largest digital health platforms for men, to make KYZATREX®, an FDA-approved oral testosterone replacement therapy for adult men with low or no testosterone...

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®...

At World Sleep 2025, Avadel Pharmaceuticals will present new data on LUMRYZ™ (sodium oxybate) for extended-release oral suspension

Avadel Pharmaceuticals plc a biopharmaceutical company focused on transforming medicines to transform lives, today announced that new data supporting the use of LUMRYZ as a narcolepsy treatment will be presented in one oral presentation and 16...

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...

In the IDeate-Lung01 Phase 2 trial, Ifinatamab Deruxtecan demonstrated clinically meaningful response rates in patients with extensive-stage small cell lung cancer

Results from the IDeate-Lung01 phase 2 trial showed that ifinatamab deruxtecan (I-DXd) demonstrated clinically meaningful response rates in patients with previously treated extensive-stage small cell lung cancer (ES-SCLC). These data were...