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

News

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 IRP Approval was supported by 3 pivotal trials conducted by Akebia Therapeutics, which showed increased iron levels along with reduction in serum phosphorus in CKD pts Averoa licensed Xoanacyl from Akebia in Dec 2022, enhancing its…

ByRidhi RastogiJune 16, 2025

News

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 states Approval was based on P-III (CheckMate-77T) study assessing neoadj. Opdivo + CT vs neoadj. PBO & CT…

ByRidhi RastogiMay 19, 2025

News

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 treatment LithiX 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

News

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 Europe As 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

News

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 regions Trial (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

News

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

News

Pfizer Secures the EC’s Approval for Abrysvo (Respiratory Syncytial Virus Vaccine) for RSV Lower Respiratory Tract Disease

Shots: The EC has approved Abrysvo to prevent lower respiratory tract disease (LRTD) caused by RSV in individuals (aged 18-59yrs.) across all EU states including Iceland, Liechtenstein, and Norway. Approval was based on a pivotal P-III (MONeT) study that assesses the safety, tolerability & immunogenicity of Abrysvo vs PBO in adults (aged 18-59yrs.) at risk…

ByDipanshu DixitApril 1, 2025

News

BMS’ Opdivo Receives the CHMP’s Positive Opinion as a Neoadjuvant Treatment of Resectable NSCLC

Shots: The CHMP has recommended Opdivo + Pt-based CT as neoadj. followed by Opdivo alone as adj. treatment of adults with resectable NSCLC at high risk of recurrence & PD-L1 expression ≥1%. If approved, EC’s decision would be valid in all 30 EEA states The P-III (CheckMate-77T) study assessed neoadj. Opdivo + CT, followed by surgery…

ByRidhi RastogiMarch 31, 2025

News

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

Shots: The US FDA has approved BLA of Conexxence & Bomyntra, biosimilar versions of Prolia & Xgeva (denosumab) for all indications of the reference products Approval was supported by extensive analytical development & similarity assessment based on 2 trials: one assessing its PK, PD, & immunogenicity in healthy volunteers, & other evaluating its efficacy, PD, safety,…

ByRidhi RastogiMarch 27, 2025

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

Pfizer Secures the EC’s Approval for Abrysvo (Respiratory Syncytial Virus Vaccine) for RSV Lower Respiratory Tract Disease

BMS’ Opdivo Receives the CHMP’s Positive Opinion as a Neoadjuvant Treatment of Resectable NSCLC

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

Contact US

OUR INFORMATION

FOLLW US

FOLLW US

Sign Up to Our Newsletter