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:
Daiichi Sankyo & AstraZeneca Report the Topline P-III (DESTINY-Breast05) Trial Data of Enhertu for High-Risk Early Breast Cancer
Read More: Daiichi Sankyo & AstraZeneca
Merck Presents P-III (HYPERION) Trial Data of Winrevair (sotatercept-csrk) for Pulmonary Arterial Hypertension at ERS 2025
Read More: Merck
Amgen Reports P-III (VESALIUS-CV) Trial Findings on Repatha (Evolocumab) to Reduce Cardiovascular Risk in Adults
Read More: Amgen
Regeneron’s Evkeeza Receives the US FDA’s Approval to Treat Homozygous Familial Hypercholesterolemia in Younger Patients
Read More: Regeneron
AbbVie Reports the US FDA’s NDA submission of Tavapadon to Treat Parkinson’s Disease
Read More: AbbVie
Johnson & Johnson’s Tremfya (Guselkumab) Receives the US FDA’s Approval for Pediatric Plaque Psoriasis and Active Psoriatic Arthritis
Read More: J&J
Novo Nordisk Reports the US FDA’s BLA Submission of Mim8 (Denecimig) for Haemophilia A with or without Inhibitors
Read More: Novo Nordisk
RAPT Therapeutics Receives the US FDA’s IND Clearance to Evaluate RPT904 for Food Allergy
Read More: RAPT Therapeutics
Novartis’ Rhapsido (Remibrutinib) Receives the US FDA’s Approval for Chronic Spontaneous Urticaria
Read More: Novartis
Pharming Reports the US FDA’s sNDA Acceptance and Priority Review to Leniolisib for Activated Phosphoinositide 3-Kinase Delta Syndrome
Read More: Pharming
AbbVie Reports the US FDA’s BLA Submission of Pivekimab Sunirine to Treat Blastic Plasmacytoid Dendritic Cell Neoplasm
Read More: AbbVie
Jazz Pharmaceuticals Reports the US FDA’s Approval of Zepzelca (Lurbinectedin) + Tecentriq (Atezolizumab) for ES-SCLC
Read More: Jazz Pharmaceuticals & Genentech
Daiichi Sankyo and AstraZeneca Report the US FDA’s sBLA Acceptance of Enhertu Regimen for HER2+ Breast Cancer
Read More: Daiichi Sankyo & AstraZeneca
Health Hope Pharma Collaborates with Gilead Sciences to Advance Encequidar in Virology
Read More: Health Hope Pharma & Gilead
Hinge Bio Collaborates with Kyorin Pharmaceutical to Advance HB2198 in Japan for Autoimmune Diseases
Read More: Hinge Bio and Kyorin Pharmaceutical
Novocure Reports Final P-III (METIS) Trial Data on Tumor Treating Fields (TTFields) Therapy for Brain Metastases from NSCLC
Read More: Novocure
Abbott Receives Health Canada’s Approval for Esprit BTK System to Treat Chronic Limb Threatening Ischemia Below the Knee
Read More: Abbott
Hologic Secures the US FDA’s 510(k) Clearance & European CE Mark for Panther Fusion GI Bacterial Assays to Advance Gastroenteritis Diagnostics
Read More: Hologic
Genmab to Acquire Merus for ~$8B
Read More: Genmab & Merus
Halozyme Therapeutics to Acquire Elektrofi for ~$900M, Expanding its Drug Delivery Offerings
Read More: Halozyme Therapeutics and Elektrofi
Amneal Pharmaceuticals Reports the US FDA’s BLA Filing for Biosimilar Candidate to Xolair (Omalizumab)
Read More: Amneal Pharmaceuticals
Gedeon Richter and Hikma Pharmaceuticals Receive the US FDA’s Approval for Enoby and Xtrenbo (Biosimilar, Prolia & Xgeva)
Read More: Gedeon Richter & Hikma Pharmaceuticals
Biocon Biologics Obtains the US Market Launch Date for Bosaya and Aukelso (Biosimilar, Prolia & Xgeva)
Read More: Biocon Biologics
Zoetis’ Dectomax-CA1 Injectable Receives the US FDA’s Conditional Approval to Prevent New World Screwworm Infestations in Cattle
Read More: Zoetis
Related Post: PharmaShots Weekly Snapshots (Sep 22, 2025 – Sep 26, 2025)
