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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...

MediPharm Labs launches a new nighttime inhaler, expanding its leading CBN oil portfolio

MediPharm Labs Corp. a pharmaceutical company specializing in precision-based cannabinoids, is pleased to announce it has launched the new Shake & Puff CBN THC Nighttime Inhaler in Canada. This innovative product expands MediPharm’s leading CBN...

Haleon’s Otrivin® Brand Now Features Aptar’s First Nasal Pump Made with 52% Bio-based Material

Aptar Pharma, a global leader in drug delivery and active material science solutions and services, is proud to announce that its Freepod® nasal spray pump - one of the delivery systems for Haleon's Otrivin® brand - is now made with mass balance...

Avenacy Unveils the Launch of Dehydrated Alcohol Injection, USP Vials in the U.S. Market

Avenacy, a specialty pharmaceutical company focused on supplying critical injectable medications, announced the launch of Dehydrated Alcohol Injection, USP in the United States as a therapeutic generic equivalent of Ablysinol®, which ended its...

Fresenius Expands Biosimilars Portfolio with Denosumab Launch in the U.S

Fresenius announced that its operating company Fresenius Kabi, has introduced two new biosimilars - Conexxence® (denosumab-bnht) and Bomyntra® (denosumab-bnht) - in the United States. These denosumab biosimilars are approved by the FDA for all...

The iPSCore™ platform, developed by iXCells Biotechnologies, enables the generation of highly characterized iPSC-derived human cell models

iXCells Biotechnologies USA, Inc. (“iXCells”), a leading cell technology company specializing in the generation of predictive human disease models is pleased to announce the launch of its modular iPSCore™ platform. iXCells’ mission is to empower...

Lubrizol reveals a significant milestone for its innovative, patented Apisolex™ polymer excipient

Lubrizol announces that an Apisolex™ polymer excipient-enabled drug formulation is in Phase 1 clinical trials. Introduced to the market in 2022, Apisolex polymer excipient is a polyamino acid-based polymer that enhances the solubility of BCS Class...

Samsung Bioepis and Organon’s HADLIMA™ Gains FDA Interchangeability Designation, Expanding Access to Adalimumab Alternative

Samsung Bioepis Co., Ltd. and Organon & Co. announced that the US Food and Drug Administration (FDA) has designated the HADLIMA™ (adalimumab-bwwd) high- and low-concentration (40 mg/0.4 mL, 40 mg/0.8 mL) autoinjectors and high-concentration...

Fresenius Kabi Introduces Epinephrine Injection, USP, in 30 mg/30 mL Multi-Dose Vials

Fresenius Kabi, an operating company of Fresenius, announced today that Epinephrine Injection, USP, is now available in the United States in 30 mg per 30 mL multi-dose vials. Epinephrine Injection 30 mg per 30 mL is a prescription medicine used...

Otulfi® (ustekinumab-aauz) by Fresenius Kabi Now FDA-Approved as an Interchangeable Biosimilar

Fresenius Kabi, an operating company of Fresenius, and Formycon AG, announced that the U.S. Food and Drug Administration (FDA) designated Otulfi® (ustekinumab-aauz) as an interchangeable biosimilar to the reference product Stelara® (ustekinumab)....

Latest SURPASS-3 Trial Data Reveals How Tirzepatide Treatment Affects Muscle Composition in Type 2 Diabetes

AMRA Medical, as part of a collaborative effort composed of researchers from the University of Glasgow, University Hospitals Cleveland, and Eli Lilly and Company, recently conducted a detailed post-hoc analysis of Lilly’s SURPASS-3 trial. The...

BioClear Toenail Fungus Device Under Review: Effective LED Laser for Healthy Nails & Discoloration Treatment

Toenail fungus, medically known as onychomycosis, is more than just a cosmetic issue. It's a persistent condition that affects the appearance, health, and comfort of your feet. What begins as a small yellow or white spot under the nail can...

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