Sun Pharma Launches Unloxcyt (Cosibelimab-ipdl) for the Treatment of aCSCC

Shots: Sun Pharma has reported Unloxcyt (cosibelimab-ipdl) is now available in the US for adults with metastatic or locally advanced cutaneous squamous cell carcinoma (CSCC) who are not eligible for curative surgery or radiation Approval of label update was based on long-term pivotal CK-301-101 data, showing improved ORR, including higher CR, and DoR without new…

ByDipanshu DixitJanuary 16, 2026

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LIB Therapeutics Receives the FDA Approval for Lerochol (Lerodalcibep-liga) for Adults with Elevated LDL Cholesterol

Shots: The US FDA has approved Lerochol as an LDL-C lowering therapy for adults with hypercholesterolemia, including HeFH; US launch as a PFS is expected in spring 2026, with an autoinjector later in 2026, while EMA approval is anticipated in Jun 2026 alongside additional global regulatory filings Approval was supported by the global P-III (LIBerate) trial, enrolling over 2,900 CVD patients and without…

ByDipanshu DixitDecember 12, 2025

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Doc.com Launches AI & Blockchain Telemedicine Platform in the US

Shots: Doc.com launches its AI & blockchain-powered telemedicine platform in the US to improve patient access, data security, & care coordination Pts can securely connect with licensed in-state healthcare providers via mobile using the platform, with up to 15min. of complimentary teleconsultation offered during launch, available in eligible jurisdictions & subject to applicable regulations, followed…

ByRidhi RastogiNovember 12, 2025

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Phibro Animal Health Unveils Restoris Piezoelectric Dental Gel for Dogs in the US

Shots: Phibro Animal Health has launched Restoris piezoelectric dental gel for the treatment & support of long-term oral health in dogs with periodontal disease in the US Laboratory & clinical studies showed Restoris reduced periodontal pocket depth & promoted alveolar bone regeneration around treated teeth within 30 days Restoris is applied into periodontal pockets via…

ByRidhi RastogiOctober 31, 2025

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Biocon Biologics Obtains the US Market Launch Date for Bosaya and Aukelso (Biosimilar, Prolia & Xgeva)

Shots: Biocon Biologics & Amgen have entered into a settlement & license agreement, allowing the US launch of Bosaya (60mg/mL, SC, PFS) & Aukelso (70mg/mL, SC, single-dose vial), provisional interchangeable biosimilars to Prolia & Xgeva (denosumab) by Oct 1, 2025 Clinical data showed both biosimilars matched the reference product in quality, safety & efficacy, plus Bosaya…

ByRidhi RastogiOctober 3, 2025

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BioPorto Launches ProNephro AKI (NGAL) to Detect Acute Kidney Injury in the US

Shots: BioPorto has reported the US launch of the ProNephro acute kidney injury (AKI) test through its collaboration with Roche, following its FDA 510(k) clearance on Roche’s cobas c 501 analyzers for hospital clinical laboratories ProNephro AKI (NGAL) is an AKI biomarker test for pediatric use (3mos.–21yrs.), which helps identifying ICU pts at risk of…

ByRidhi RastogiAugust 28, 2025

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Celltrion Launches Osenvelt and Stoboclo (Biosimilars, Xgeva and Prolia) in the US

Shots: Celltrion has launched Osenvelt & Stoboclo, biosimilar versions of Amgen’s Xgeva & Prolia (denosumab) in the US Stoboclo (60mg/mL) treats postmenopausal women & men with osteoporosis at high fracture risk, glucocorticoid-induced osteoporosis in both sexes, & increases bone mass in men on androgen deprivation therapy for nonmetastatic prostate cancer & women on adjuvant aromatase inhibitors…

ByRidhi RastogiJuly 8, 2025

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Johnson & Johnson MedTech Reports the US Launch of VOLT Wrist and Proximal Humerus Plating Systems

Shots: J&J MedTech has launched Variable Angle Optimized Locking Technology (VOLT) Distal Radius (Wrist) & VOLT Proximal Humerus 3.5 Plating System in the US VOLT Wrist, developed with the AO Technical Commission, features the VOLT Two-Column Distal Radius Rim Plate with a new shape that sits more distal to target fragments & is less prominent…

ByRidhi RastogiJune 20, 2025

Sun Pharma Launches Unloxcyt (Cosibelimab-ipdl) for the Treatment of aCSCC

LIB Therapeutics Receives the FDA Approval for Lerochol (Lerodalcibep-liga) for Adults with Elevated LDL Cholesterol

Doc.com Launches AI & Blockchain Telemedicine Platform in the US

Phibro Animal Health Unveils Restoris Piezoelectric Dental Gel for Dogs in the US

Biocon Biologics Obtains the US Market Launch Date for Bosaya and Aukelso (Biosimilar, Prolia & Xgeva)

BioPorto Launches ProNephro AKI (NGAL) to Detect Acute Kidney Injury in the US

Celltrion Launches Osenvelt and Stoboclo (Biosimilars, Xgeva and Prolia) in the US

Johnson & Johnson MedTech Reports the US Launch of VOLT Wrist and Proximal Humerus Plating Systems

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