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Novo Nordisk’s Ozempic pill—the only FDA-approved oral peptide GLP-1 for adults with Type 2 Diabetes—will soon be available in the U.S

Novo Nordisk announced that starting Monday, May 4, Ozempic® (semaglutide) tablets 1.5 mg, 4 mg, and 9 mg will be available for adults with type 2 diabetes in the US. Ozempic® is the only FDA-approved oral peptide GLP-1 medication for adults with...

UCB to acquire Candid Therapeutics, strengthening its immunology pipeline with novel T-cell engagers

UCB, a global biopharmaceutical company, announced signing of a definitive agreement under which it would acquire Candid Therapeutics (Candid), a privately held clinical-stage biotechnology company redefining the treatment of autoimmune and...

Bristol Myers Squibb and Pfizer to provide Eliquis® (apixaban) through the Mark Cuban Cost Plus Drug Company

The Bristol Myers Squibb-Pfizer Alliance announced the launch of a collaboration with Mark Cuban Cost Plus Drug Company (Cost Plus Drugs) to offer Eliquis® (apixaban) on CostPlusDrugs.com. Eliquis is one of the most widely prescribed oral...

Eton Pharmaceuticals Strengthens Rare Disease Portfolio with U.S. Commercialization Rights to HEMANGEOL® Oral Solution

Eton Pharmaceuticals, Inc an innovative pharmaceutical company focused on developing and commercializing treatments for rare diseases, announced it has in-licensed U.S. commercialization rights to HEMANGEOL® oral solution from Pierre Fabre...

Unique Mouse Model Enables genOway to Transform Prediction of Antibody Therapies in Humans

Antibody therapies are changing the treatment of cancer, inflammatory diseases and infections. However, many promising drug candidates fail in clinical trials. A study in Science Immunology shows that genOway's genO-hFcγR mouse model enables more...

With timsOmni™ Mass Spectrometry, Bruker Advances Functional Proteomics 2.0 for Deeper Insights into Disease Biology

Bruker Corporation announced new advancements to enable Functional Proteomics 2.0 workflows on the timsOmni™ mass spectrometer to enable disease researchers to move beyond canonical protein lists toward biologically or pathologically functional...

China approves Libevitug, first-in-class therapy for hepatitis D

Huahui Health announced that China National Medical Products Administration (NMPA) has granted conditional approval to its Libevitug injection for the treatment of chronic hepatitis D virus infection in adults with or without compensated...

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...

Novotech Appoints Anand Tharmaratnam as Chief Executive Officer

Novotech, a globally recognized full-service biotech clinical research organization (CRO), is pleased to announce the appointment of Dr. Anand Tharmaratnam as its new Chief Executive Officer. Dr. Tharmaratnam brings nearly three decades of...

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...

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

Emulate, Inc., the leading provider of next-generation Organ-on-a-Chip technology, in partnership with FUJIFILM Cellular Dynamics, Inc., a pioneering global developer and manufacturer of human induced pluripotent stem cells (iPSCs), today...

Fresenius Kabi’s biosimilars Conexxence® and Bomyntra® (denosumab-bnht) receive interchangeable designation from the FDA

Fresenius Kabi, part of the global healthcare company Fresenius, and a leading provider of essential medicines and medical technologies, announced that the U.S. Food and Drug Administration (FDA) designated Conexxence®(1) and Bomyntra®(2)...

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®...

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...

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®...

Theravance Biopharma completes enrollment in Phase 3 CYPRESS study of Ampreloxetine for neurogenic orthostatic hypotension

Theravance Biopharma, Inc. announced completion of enrollment in the open-label portion of its pivotal Phase 3 CYPRESS study in patients with symptomatic neurogenic orthostatic hypotension (nOH) due to multiple system atrophy (MSA), a rare and...

To advance gene therapy development and manufacturing, ProBio has launched GMP AAV manufacturing services at its Hopewell facility

ProBio, a leading contract development and manufacturing organization (CDMO) specializing in gene and cell therapy, announced the launch of its cGMP Adeno-Associated Virus (AAV) manufacturing services at its 128,000 sq. ft. state-of-the-art...

Jazz Pharmaceuticals announces the U.S. FDA approval of Modeyso™ (dordaviprone) as the first and only treatment for recurrent H3 K27M-mutant diffuse midline glioma

Jazz Pharmaceuticals plc announced that the U.S. Food and Drug Administration (FDA) has granted accelerated approval for Modeyso™ (dordaviprone) for the treatment of adult and pediatric patients 1 year of age and older with diffuse midline glioma...

Roche's first respiratory test, powered by TAGS technology, has received FDA clearance for SARS-CoV-2, Influenza A, Influenza B, and RSV

Roche announced the U.S. Food and Drug Administration (FDA) 510(k) clearance for the cobas® Respiratory 4-flex. This is the first FDA-cleared assay utilizing Roche's innovative TAGS (Temperature-Activated Generation of Signal) technology, designed...

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