This week, PharmaShots’ news was all about the updates on Clinical Trials, Regulatory, Pharma, MedTech, M&A, Animal Health, and Biosimilars. Check out our full report below:
Roche Reports P-III (INShore) Trial Findings on Gazyva (Obinutuzumab) for Idiopathic Nephrotic Syndrome
Read More: Roche
Merck Reports the P-III (LITESPARK-022) Trial Data on Welireg + Keytruda to Treat Clear Cell Renal Cell Carcinoma (RCC)
Read More: Merck
J&J Reports Long-Term Extension Results from GALAXI-2, GALAXI-3, and GRAVITI Trials of Tremfya (Guselkumab) for Crohn’s Disease
Read More: J&J
AbbVie Reports Topline P-III (M19-044) Trial Data on Rinvoq (Upadacitinib) to Treat Non-Segmental Vitiligo
Read More: AbbVie
Merck Reports the US FDA’s Approval of Winrevair (Sotatercept-csrk) to Treat Adults with Pulmonary Arterial Hypertension (PAH)
Read More: Merck
Eisai and Biogen Report the Health Canada’s Approval of Leqembi (Lecanemab) to Treat Alzheimer’s Disease
Read More: Eisai & Biogen
Bayer Reports the US FDA’s Approval of Lynkuet (Elinzanetant) to Treat Vasomotor Symptoms
Read More: Bayer
Eli Lilly’s Omvoh (mirikizumab-mrkz) Receives the US FDA’s Approval for Ulcerative Colitis
Read More: Eli Lilly
Syndax Pharmaceuticals’ Revuforj (Revumenib) Receives the US FDA’s Approval for NPM1-Mutated R/R Acute Myeloid Leukemia
Read More: Syndax Pharmaceuticals
AstraZeneca Reports the EC’s Approval of Koselugo (Selumetinib) for Treating Neurofibromatosis Type 1
Read More: AstraZeneca
Merck Receives EC’s Approval for Perioperative Keytruda for Locally Advanced Head and Neck Squamous Cell Carcinoma (LA-HNSCC)
Read More: Merck
Daiichi Sankyo Reports the Health Canada’s Approval of Enhertu for HER2 Low/Ultralow Metastatic Breast Cancer (MBC)
Read More: Daiichi Sankyo
BioMarin Reports the US FDA’s sBLA Acceptance & Priority Review of Palynziq (Pegvaliase-pqpz) to Treat Phenylketonuria
Read More: BioMarin
GSK Secures Exclusive License to Syndivia’s ADC Candidate for Prostate Cancer
Read More: GSK & Syndivia
Incyte Partners with Enable Injections for enFuse On-Body Delivery System
Read More: Incyte & Enable Injections
GSK Collaborates with Empirico to Advance EMP-012 Across Inflammatory Respiratory Diseases
Read More: GSK & Empirico
ModeX Therapeutics (OPKO Health) Enters $1B+ Deal with Regeneron to Develop Multispecific Antibodies for Select Therapeutic Indications
Read More: ModeX Therapeutics & Regeneron
Boehringer Ingelheim Licenses an Autoimmune Disease Therapy from Kyowa Kirin for ~$744.4M
Read More: BI & Kyowa Kirin
4D Molecular Therapeutics Collaborates with Otsuka Pharmaceutical to Develop and Commercialize 4D-150 in the APAC Region
Read More: 4DMT & Otsuka
Avvio Medical’s Avvio Enhanced Lithotripsy System (ELS) Receives the US FDA’s Breakthrough Device Designation (BDD) for Kidney Stone Treatment
Read More: Avvio Medical
Roche Receives the European CE Mark for its Elecsys Dengue Ag Test for Dengue Virus Detection
Read More: Roche
Eli Lilly Strengthens its Gene Therapy Capabilities with Adverum Acquisition
Read More: Eli Lilly & Adverum
Novartis to Acquire Avidity Biosciences for ~$12B, Boosting its Neuroscience Pipeline
Read More: Novartis and Avidity Biosciences
Thermo Fisher Scientific to Acquire Clario for ~$9.4B
Read More: Thermo Fisher Scientific & Clario
Metsera Declares Novo Nordisk’s ~$9B Acquisition Proposal a Superior Offer to Pfizer Merger Agreement
Read More: Metsera & Novo Nordisk
Samsung Bioepis Enters Asset Purchase Deal with Biogen for Byooviz (Biosimilar, Lucentis) and Opuviz (Biosimilar, Eylea) in the EU
Read More: Samsung Bioepis & Biogen
The FDA Grants Interchangeability Designation to Celltrion’s Stoboclo & Osenvelt (Biosimilars, Prolia & Xgeva)
Read More: Celltrion
Fresenius Kabi’s Conexxence and Bomyntra (Biosimilars, Prolia & Xgeva) Receives FDA’s Interchangeable Designation
Read More: Fresenius Kabi
GlycoNex Doses Last Patient in P-III Trial of SPD8 (Biosimilar, Prolia/Xgeva) to Treat Osteoporosis
Read More: GlycoNex
Phibro Animal Health Unveils Restoris Piezoelectric Dental Gel for Dogs in the US
Read More: Phibro Animal Health
Related Post: PharmaShots Weekly Snapshots (Oct 21, 2025 – Oct 24, 2025)
