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Amneal Pharmaceuticals and mAbxience’s Boncresa and Oziltus (Biosimilar, Prolia and Xgeva) Receive the US FDA’s Approval 
 Shots:  The US FDA has approved Boncresa (denosumab-mobz), a biosimilar version of Prolia, and Oziltus (denosumab-mobz), a biosimilar version of Xgeva  Denosumab is an mAb that reduces bone resorption and is used in oncology and osteoporosis indications   Under the Amneal and mAbxience collaboration, mAbxience manages development and manufacturing, and Amneal has exclusive US commercialization rights  Ref: Amneal Pharmaceuticals| Image: Amneal Pharmaceuticals and mAbxience | Press Release Related News:- Kashiv BioSciences and Amneal…
December 22, 2025
BioMarin to Acquire Amicus Therapeutics for ~$4.8B
Shots: BioMarin has entered into a definitive agreement to acquire Amicus, strengthening BioMarin's commercial portfolio with Galafold (migalastat) for Fabry Disease & Pombiliti (cipaglucosidase alfa-atga) + Opfolda (miglustat) for Pompe Disease As per the deal, BioMarin will acquire Amicus for $14.5/share in an all-cash transaction for a total equity value of ~$4.8B; closing is expected in Q2’26 Amicus also…
December 22, 2025
Daiichi Sankyo
Daiichi Sankyo Reports the EMA’s MAA Validation of Datroway to Treat Metastatic Triple Negative Breast Cancer
Shots: The EMA has validated the Type II Variation MAA for Daiichi's Datroway (datopotamab deruxtecan) as monotx. For the 1L treatment of adults with unresectable or metastatic TNBC who are ineligible for PD-1/PD-L1 inhibitor therapy; additional regulatory filings are underway MAA was supported by the global P-III (TROPION-Breast02) trial assessing Datroway vs CT in 644…
December 19, 2025
Shanghai Henlius Receives the US FDA IND Clearance for HLX18 (Biosimilar, Opdivo)  
Shots:  The US FDA has granted IND clearance to HLX18 (nivolumab), a biosimilar version of Opdivo, for the treatment of certain resected solid tumors   Novolumab is an mAb targeting PD-1 to enhance anti-tumor immune responses and is approved worldwide for cancers, including melanoma, mesothelioma, head and neck, and urothelial carcinoma   HLX17 (pembrolizumab biosimilar) and HLX13 (ipilimumab biosimilar) have entered worldwide multicenter P-I…
December 19, 2025
Abbott
Abbott Reports FDA Clearance and CE Mark Approval of its Amplatzer Piccolo Delivery System for Premature Babies with a Hole in the Heart
Shots: Abbott has received the US FDA clearance & European CE Mark for its Amplatzer Piccolo Delivery System, used with Amplatzer Piccolo Occluder, to treat premature babies (≥2lbs) with patent ductus arteriosus (PDA; hole in the heart) Approved in the US & EU in 2019, Amplatzer Piccolo Occluder is a minimally invasive transcatheter device, smaller…
December 19, 2025
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