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Rapid Nexus Reports the US FDA’s 510(k) Clearance of Hemastyl Gel Device to Support Wound Healing
Shots: The US FDA has granted 510(k) clearance to the Hemastyl gel device to support chronic wound healing  The Hemastyl gel is a topical formulation that enhances the tissue-repair environment to support wound closure, while the Periwound NerveStim device works with Hemastyl to restore periwound function The Periwound NerveStim device is in final FDA approval stages, with…
November 14, 2025
Day One Biopharmaceuticals to Acquire Mersana Therapeutics for ~$285M
Shots: Day One has entered into a definitive merger agreement to acquire Mersana, delisting Mersana from the public market & making it a wholly owned subsidiary upon deal completion As per the deal, Day One will acquire Mersana for $25/share plus a CVR of ~$30.25/share tied to certain clinical development, regulatory, & commercial milestones for…
November 13, 2025
BioNet’s VacPertagen Receives the CHMP’s Positive Opinion for Pertussis Disease 
Shots:  The CHMP has recommended VacPertagen as a booster aganist Pertussis for pts (age≥12) and for passive infant protection via maternal immunization during pregnancy   VacPertagen is an acellular pertussis vaccine with two components, including recombinant Pertussis Toxin (PTgen) and filamentous haemagglutinin (FHA), providing targeted protection without unnecessary antigens   VacPertagen’s benefits have been demonstrated in three clinical studies involving adults, adolescents, and pregnant women  Ref: BioNet| Image: BioNet| Press Release…
November 13, 2025
Fondazione Telethon’s Waskyra Receives the CHMP’s Positive Opinion for WAS 
Shots:  The CHMP has recommended Waskyra, an ex vivo gene therapy for Wiskott-Aldrich Syndrome (WAS)  Waskyra is a single-administration therapy that uses a patient’s CD34+ hematopoietic stem and progenitor cells, modified with a lentiviral vector carrying the WAS gene  The therapy will be available to pts at IRCCS Ospedale San Raffaele, where the clinical trial was conducted. The BLA for WAS…
November 13, 2025
Gan & Lee Pharmaceuticals Gains the CHMP’s Positive Opinion for Ondibta (Biosimilar, Lantus SoloStar) 
Shots:  The CHMP has recommended Ondibta, a biosimilar insulin glargine pre-filled pen for pts (age≥ 2), reference medicine Lantus SoloStar. The EC will now review the opinion, and approval is anticipated across the EU and EEA states   Insulin glargine is a long-acting, once-daily basal insulin analog that provides up to 24 hours of steady, peakless glucose-lowering activity   Ondibta completed head-to-head P-III trials in both the EU and the US against Lantus, with studies in…
November 13, 2025
Thermo Fisher Scientific’s EXENT System Receives the US FDA’s 510(k) Clearance to Aid Multiple Myeloma Diagnosis
Shots: Thermo Fisher Scientific has received FDA 510(k) clearance for the EXENT Analyser & Immunoglobulin Isotypes (GAM) Assay, an automated mass spectrometry-based platform, for aiding diagnosis of MM & related conditions The EXENT System detects & isotypes low-concentration M-proteins with high sensitivity to identify them by molecular weight, differentiating endogenous from therapeutic antibodies & providing…
November 13, 2025
Chiesi Group Collaborates with Aliada Therapeutics to Develop Enzyme Replacement Therapies for Lysosomal Storage Disorders
Shots: Chiesi Group has entered into an exclusive license deal with Aliada Therapeutics, an AbbVie subsidiary, to advance its Blood-Brain Barrier (BBB)-crossing platform technology for developing therapies targeting lysosomal storage disorders As per the deal, Chiesi will receive an exclusive global license to develop & commercialize enzyme replacement therapies using its BBB-crossing platform, with Aliada receiving…
November 13, 2025
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