The US FDA New Drug Approvals in November 2025

Shots: Innovation surged in November, with cutting-edge science and strategic collaborations reshaping the drug development landscape across oncology, renal disease, hereditary conditions, and more The US FDA cleared five standout therapies, including Bayer’s Hyrnuo (Sevabertinib), UCB’s Kygevvi (Doxecitine + Doxribtimine), and Arrowhead’s Redemplo, underscoring a month of meaningful clinical progress November 2025 closed with five approvals, matching last year’s total, signaling sustained momentum and a steady…

ByDipanshu DixitDecember 9, 2025

NEWS

Nurix Therapeutics Presents New Data from P-I of Bexobrutideg (NX-5948) in Relapsed/Refractory CLL at ASH’25

Shots: Nurix reported updated P-Ia/I b data for bexobrutideg in which P-Ia (n=48) showed an ORR of 83% incl. 2 CRs & a median PFS of 22.1mos. across all doses (50 mg to 600 mg OD) in heavily pretreated relapsed/refractory CLL/SLL pts.; P-Ib data (n=42) indicated higher ORR i.e. 83.3% & longer PFS at the 600mg…

ByPrince GiriDecember 8, 2025

NEWS

Kelun-Biotech and Crescent Biopharma Enter Strategic Deal to Accelerate CR-001 and SKB105 Programs

Shots: Crescent granted Kelun exclusive rights to research, develop, manufacture & commercialize CR-001 in Greater China, while Kelun granted Crescent similar exclusive rights for SKB105 globally (excl. Greater China) Kelun will receive $80M upfront, ~$1.25B in milestones, tiered mid–single to low-double-digit royalties & potential change-of-control payments, while Crescent will get $20M upfront, ~$30M in milestones…

ByRidhi RastogiDecember 5, 2025

INSIGHTS+

Key Biosimilars Events of November 2025

Shots: Regulatory momentum accelerates globally, with major approvals across the US, EU, UK, and Canada for biosimilars targeting high-value biologics such as Simponi, Stelara, Perjeta, Prolia/Xgeva, Remicade, Xolair, Eylea, Lucentis, and Lantus SoloStar, strengthening patient access in immunology, oncology, ophthalmology, diabetes, and allergy/asthma Sandoz, Alvotech, Celltrion, Henlius/Organon, Teva, and others expand portfolios and market reach, including multiple EC and…

ByDipanshu DixitDecember 2, 2025

NEWS

Samsung Bioepis Reports EU Launch of Obodence & Xbryk (Biosimilar, Prolia & Xgeva)

Shots: Samsung Bioepis has launched Obodence (60mg PFS) & Xbryk (120mg vial), biosimilar versions of Prolia & Xgeva, for bone health treatments, with commercial availability expected by Dec 2025 & Jan 2026, respectively Obodence treats postmenopausal women & men with osteoporosis at high fracture risk, glucocorticoid-induced osteoporosis in both sexes, & bone loss in men on…

ByRidhi RastogiDecember 1, 2025

NEWS

The US FDA Approves Lupin’s Armlupeg (Biosimilar, Neulasta)

Shots: The US FDA has approved Armlupeg (pegfilgrastim-unne) as a biosimilar version of Neulasta (pegfilgrastim) Armlupeg (6 mg/0.6 mL) is administered as a single-dose SC injection. It is indicated to reduce the incidence of febrile neutropenia in pts with non-myeloid cancers undergoing myelosuppressive CT and to improve survival following acute myelosuppressive radiation exposure Armlupeg will be produced at Lupin’s Biotech facility…

ByDipanshu DixitDecember 1, 2025

NEWS

Abbott Expands Leadership in Cancer Diagnostics with ~$23B Acquisition of Exact Sciences

Shots: Abbott has entered into a definitive agreement to acquire Exact Sciences, making Exact a subsidiary of Abbott upon deal completion As per the deal, Abbott will acquire Exact Sciences for $105 per share, representing a total equity value of ~$21B & an estimated enterprise value of $23B, with financing that includes absorbing Exact’s ~$1.8B in…

ByRidhi RastogiNovember 21, 2025

NEWS

GSK Collaborates with LTZ Therapeutics to Advance Myeloid Cell Engager Therapies in Oncology

Shots: GSK has entered into a strategic research collaboration with LTZ Therapeutics to advance the development of novel myeloid cell engagers (MCEs) in oncology, leveraging LTZ’s immune-engager platform Under the collaboration, GSK & LTZ aim to develop up to four MCE therapies for hematologic cancers & solid tumors, with GSK receiving an exclusive option to…

ByRidhi RastogiNovember 19, 2025

NEWS

J&J Accelerates Cancer Innovation with $3.05B Halda Therapeutics Acquisition

Shots: J&J has entered into a definitive agreement to acquire Halda Therapeutics, strengthening its oncology pipeline As per the deal, J&J will acquire Halda for $3.05B in cash, with the deal treated as a business combination & expected to close in the coming months Acquisition will add Halda’s Regulated Induced Proximity TArgeting Chimera (RIPTAC) platform…

ByRidhi RastogiNovember 18, 2025

NEWS

Adagene Enters ~$845M Licensing Deal with Third Arc Bio to Develop Masked CD3 T Cell Engagers

Shots: Third Arc Bio has entered into a licensing agreement with Adagene to utilize its SAFEbody technology platform for generating masked CD3 T cell engagers against unique tumor-associated antigens As per the deal, Third Arc Bio will gain global rights to research, develop & commercialize 2 candidate molecules, while Adagene will receive a no-cost option…

ByRidhi RastogiNovember 14, 2025

The US FDA New Drug Approvals in November 2025

Nurix Therapeutics Presents New Data from P-I of Bexobrutideg (NX-5948) in Relapsed/Refractory CLL at ASH’25

Kelun-Biotech and Crescent Biopharma Enter Strategic Deal to Accelerate CR-001 and SKB105 Programs

Key Biosimilars Events of November 2025

Samsung Bioepis Reports EU Launch of Obodence & Xbryk (Biosimilar, Prolia & Xgeva)

The US FDA Approves Lupin’s Armlupeg (Biosimilar, Neulasta)

Abbott Expands Leadership in Cancer Diagnostics with ~$23B Acquisition of Exact Sciences

GSK Collaborates with LTZ Therapeutics to Advance Myeloid Cell Engager Therapies in Oncology

J&J Accelerates Cancer Innovation with $3.05B Halda Therapeutics Acquisition

Adagene Enters ~$845M Licensing Deal with Third Arc Bio to Develop Masked CD3 T Cell Engagers

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