The EC Approves Fresenius’ Conexxence and Bomyntra (Biosimilars, Prolia & Xgeva)

Shots:The EC has approved Conexxence & Bomyntra, biosimilar versions of Prolia & Xgeva (denosumab)Approval covers all indications of the reference products incl. osteoporosis in postmenopausal women & men at high risk of fracture, SRE prevention in adults with bone-involved malignancies, giant cell tumors of bone & treatment-related bone lossAdditionally, Fresenius & Amgen…

ByRidhi Rastogi1 day ago

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FDA Approves Merck Animal Health’s Bravecto Quantum to Treat and Protect Dogs from Fleas and Ticks

Shots:The US FDA has approved Bravecto Quantum (Fluralaner for Extended-Release Injectable Suspension), a once-yearly injectable for flea and tick protection in dogs, will be available in U.S. veterinary clinics by Aug, 2025Bravecto Quantum kills adult fleas and controls flea and tick infestations (Ixodes scapularis, Dermacentor variabilis, Rhipicephalus sanguineus) for 12 mos., and Amblyomma…

ByDipanshu DixitJuly 11, 2025

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Takeda Reports US FDA Approval of GAMMAGARD LIQUID ERC for Primary Immunodeficiency

The US FDA has approved GAMMAGARD LIQUID ERC [immune globulin infusion (human)] for treating primary immunodeficiency (PI) pts (age≥2); commercialization will be anticipated in 2026 and in the EU in 2027, where it’s approved as DEQSIGA by the EMAGAMMAGARD LIQUID ERC is a 10% ready-to-use IG therapy with ≤2 µg/mL IgA, for IV or…

ByDipanshu DixitJuly 1, 2025

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New Drug Designations – May 2025  

Shots:    PharmaShots’ Designation Report provides a concise overview of the latest drug designations granted by major regulatory authorities, including the FDA, EMA, MHLW, Health Canada and NMPA  The May 2025 report covers designations granted to 44 drugs and 5 medical devices, spanning 15 small molecules, 7 biologics, 13 cell and gene therapies & 5 medical devices among others  …

ByDipanshu DixitJune 24, 2025

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Averoa Receives the EC’s Approval for Xoanacyl to Treat Chronic Kidney Disease

Shots:The EC has approved Xoanacyl (ferric citrate complex) for chronic kidney disease; UK's MAA was filed via MHRA's IRPApproval was supported by 3 pivotal trials conducted by Akebia Therapeutics, which showed increased iron levels along with reduction in serum phosphorus in CKD ptsAveroa licensed Xoanacyl from Akebia in Dec 2022, enhancing its…

ByRidhi RastogiJune 16, 2025

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BMS’ Opdivo Receives the EC’s Approval as a Perioperative Treatment of Resectable NSCLC

Shots:The EC has approved Opdivo + CT as neoadj. therapy followed by surgery & adj. Opdivo alone to treat adults with resectable NSCLC at high risk of recurrence & PD-L1 expression ≥1% in all 30 EEA statesApproval was based on P-III (CheckMate-77T) study assessing neoadj. Opdivo + CT vs neoadj. PBO & CT…

ByRidhi RastogiMay 19, 2025

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Elixir Medical Reports European MDR CE Mark Approval & Launch of LithiX Hertz Contact IVL System

Shots:Elixir has reported European MDR CE Mark approval & commercial launch of LithiX Hertz Contact (HC) Intravascular Lithotripsy (IVL) System in EU to improve calcium & percutaneous coronary intervention treatmentLithiX is a transcatheter device that uses low-profile metal hemispheres on a semi-compliant balloon to apply HC Stress, creating deep & wide fractures while…

ByRidhi RastogiApril 11, 2025

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Womed Collaborates with Kebomed Europe & Saesco Medical to Launch Womed Leaf in Europe

Shots:Womed has entered into licensing agreements with Kebomed Europe & Saesco Medical to distribute Womed Leaf, an intrauterine adhesion barrier film, across EuropeAs per the agreement, Kebomed will handle distribution across France, Germany, Sweden, Denmark, Norway, Finland, Austria & Switzerland, while Saesco Medical will oversee commercialization in Spain, Italy, Portugal, Belgium, the Netherlands…

ByRidhi RastogiApril 9, 2025

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Daiichi Sankyo and AstraZeneca Report the EC’s Approval of Enhertu for HER2 Low/Ultralow Metastatic Breast Cancer (MBC)

Shots:The EC has approved Enhertu monotx. for inoperable HR+, HER2-low/ultralow MBC whose disease progressed on & are ineligible for endocrine therapy, based on the P-III (DESTINY-Breast06) trial; regulatory review is ongoing in Japan & other regionsTrial (N=866) assessed Enhertu (5.4mg/kg) vs CT in HER2-low (n=713) & ultralow (n=153) pts, showing 38% PFS in CT-naïve…

ByRidhi RastogiApril 4, 2025

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Averoa Receives the CHMP’s Positive Opinion for Xoanacyl to Treat Chronic Kidney Disease

Shots:The CHMP has recommended Xoanacyl (ferric citrate complex) for chronic kidney disease, with an EU decision expected by Jun 2025, while the UK's MAA will be filed via MHRA's IRP, with decision anticipated in the coming mos.MAA was filed via centralized European procedure in Mar 2024 & was supported by 3 pivotal trials…

ByDipanshu DixitApril 2, 2025

The EC Approves Fresenius’ Conexxence and Bomyntra (Biosimilars, Prolia & Xgeva)

FDA Approves Merck Animal Health’s Bravecto Quantum to Treat and Protect Dogs from Fleas and Ticks

Takeda Reports US FDA Approval of GAMMAGARD LIQUID ERC for Primary Immunodeficiency

New Drug Designations – May 2025

Averoa Receives the EC’s Approval for Xoanacyl to Treat Chronic Kidney Disease

BMS’ Opdivo Receives the EC’s Approval as a Perioperative Treatment of Resectable NSCLC

Elixir Medical Reports European MDR CE Mark Approval & Launch of LithiX Hertz Contact IVL System

Womed Collaborates with Kebomed Europe & Saesco Medical to Launch Womed Leaf in Europe

Daiichi Sankyo and AstraZeneca Report the EC’s Approval of Enhertu for HER2 Low/Ultralow Metastatic Breast Cancer (MBC)

Averoa Receives the CHMP’s Positive Opinion for Xoanacyl to Treat Chronic Kidney Disease

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