PharmaShots

Samsung Bioepis and Organon’s Hadlima (Biosimilar, Humira) Receives the US FDA’s Interchangeability Designation for All Presentations

Shots:FDA has granted interchangeability designation to Hadlima, a biosimilar version of Humira (adalimumab) for prefilled syringe (40mg/0.4mL) & autoinjectors (40mg/0.4mL & 40mg/0.8mL) expanding on the prior designation for prefilled…

4 days ago

News

AnX Robotica’s MotiliCap and MotiliScan Receive the US FDA’s 510(k) Clearance for GI Motility Monitoring

Shots:The US FDA has granted 510(k) clearance to MotiliCap & MotiliScan for GI motility monitoringMotiliCap is a radiation & sedation-free motility capsule that evaluates gastrointestinal transit across stomach,…

4 days ago

News

GRIN Therapeutics Collaborates with Angelini Pharma to Co-Develop and Commercialize Radiprodil for Neurological Disorders

Shots:GRIN has granted Angelini Pharma exclusive rights to commercialize radiprodil worldwide, while GRIN will retain its rights in the US, Canada, & Mexico as well as lead global development…

4 days ago

News

Eli Lilly to Acquire SiteOne Therapeutics for ~$1B, Strengthening its Pain Pipeline

Shots:Eli Lilly has entered into a definitive agreement to acquire SiteOne Therapeutics incl. its asset, STC-004, expanding its pain pipeline As per the deal, SiteOne shareholders will receive an upfront payment…

5 days ago

INSIGHTS+

New Drug Designations – April 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 April 2025 report…

May 2025

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LIFE SCIENCES | DAILY NEWS | MAY 27, 2025 | PHARMASHOTS

May 2025

News

AstraZeneca Reports the CHMP’s Positive Opinion for Perioperative Imfinzi to Treat Muscle-Invasive Bladder Cancer (MIBC)

Shots:The CHMP has recommended Imfinzi as a perioperative treatment of MIBC; regulatory review is ongoing in Japan & other regionsOpinion was based on the P-III (NIAGARA) trial (n=1063)…

May 2025

News

RemeGen’s Telitacicept Receives the NMPA’s Approval for Generalized Myasthenia Gravis (gMG)

Shots:The NMPA has approved telitacicept for the treatment of AChR antibody-positive gMG in combination with standard therapiesIn P-III trial for gMG, telitacicept demonstrated favorable efficacy vs PBO, with 98.1%…

May 2025

News

GSK Reports Health Canada’s NDS Acceptance of Depemokimab for Asthma with Type 2 Inflammation and CRSwNP

Shots:Health Canada has accepted NDS of depemokimab as an adjunctive therapy for asthma pts (≥12yrs.) with type 2 inflammation marked by blood eosinophil count as well as inadequately controlled…

May 2025

News

AI Medical Technology’s Dermalyser Receives European CE Mark Approval for Melanoma Detection

Shots:AI Medical Technology has reported the CE mark approval of Dermalyser for melanoma detection; commercialization to begin in 2025Dermalyser was validated in AI-DSMM study across 36 Swedish centers,…

Samsung Bioepis and Organon’s Hadlima (Biosimilar, Humira) Receives the US FDA’s Interchangeability Designation for All Presentations

AnX Robotica’s MotiliCap and MotiliScan Receive the US FDA’s 510(k) Clearance for GI Motility Monitoring

GRIN Therapeutics Collaborates with Angelini Pharma to Co-Develop and Commercialize Radiprodil for Neurological Disorders

Eli Lilly to Acquire SiteOne Therapeutics for ~$1B, Strengthening its Pain Pipeline

New Drug Designations – April 2025

LIFE SCIENCES | DAILY NEWS | MAY 27, 2025 | PHARMASHOTS

AstraZeneca Reports the CHMP’s Positive Opinion for Perioperative Imfinzi to Treat Muscle-Invasive Bladder Cancer (MIBC)

RemeGen’s Telitacicept Receives the NMPA’s Approval for Generalized Myasthenia Gravis (gMG)

GSK Reports Health Canada’s NDS Acceptance of Depemokimab for Asthma with Type 2 Inflammation and CRSwNP

AI Medical Technology’s Dermalyser Receives European CE Mark Approval for Melanoma Detection

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