This week, PharmaShots’ news was all about the updates on Clinical Trials, Regulatory, Pharma, MedTech, M&A, Biosimilar, and DigiHealth. Check out our full report below:
AstraZeneca Reports P-III (FLAURA2) Trial Findings on Tagrisso Regimen to Treat EGFRm NSCLC
Read More: AstraZeneca
Eli Lilly Reports P-III (BRUIN CLL-313) Trial Data on Jaypirca for 1L Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma
Read More: Eli Lilly
Amgen and Kyowa Kirin Report Topline P-III (ASCEND) Study Results of Rocatinlimab in Moderate to Severe Atopic Dermatitis
Read More: Amgen and Kyowa Kirin
ImmunityBio Reveals P-II (QUILT-3.055) Trial Findings of Anktiva in CPI-Resistant NSCLC
Read More: ImmunityBio
Regeneron Reports Follow-Up Data from P-III (EMPOWER-Lung 3) Trial of Libtayo (Cemiplimab) to Treat NSCLC
Read More: Regeneron
Merck Reports P-III (STRIDE-13) Trial of Capvaxive for Active Immunization Against Pneumococcal Disease
Read More: Merck
Nanjing Leads Biolabs Reports First Patient Enrolment in P-Ib/II Trial of Opatisumab for Advanced Melanoma
Read More: Nanjing Leads Biolabs
Takeda’s Vonvendi Receives the US FDA’s Approval for Adults and Children with Von Willebrand Disease
Read More: Takeda
Medison and Ipsen’s Bylvay Receives the Health Canada’s Approval to Treat Cholestatic Pruritus in Alagille Syndrome Patients
Read More: Medison and Ipsen
The US FDA Approves Johnson & Johnson’s Inlexzo for BCG-Unresponsive High-Risk Non-Muscle-Invasive Bladder Cancer (HR-NMIBC)
Read More: J&J
Sanofi’s Tzield Receives the NMPA’s Approval to Delay Progression of Type 1 Diabetes
Read More: Sanofi
Sobi Reports the US FDA’s BLA Acceptance of Nanoecapsulated Sirolimus + Pegadricase for Uncontrolled Gout
Read More: Sobi
Corcept Therapeutics Reports the US FDA’s NDA Acceptance of Relacorilant to Treat Platinum-Resistant Ovarian Cancer
Read More: Corcept Therapeutics
Daiichi Sankyo Reports the EMA’s MAA Acceptance of Enhertu to Treat Solid Tumors
Read More: Daiichi Sankyo
Johnson & Johnson Reports the EMA’s MAA Submission of Icotrokinra to Treat Plaque Psoriasis (PsO)
Read More: J&J
Ferring Reports the PMDA’s NDA Acceptance of Nadofaragene Firadenovec to Treat BCG-Unresponsive High-Risk Non-Muscle-Invasive Bladder Cancer (HR-NMIBC)
Read More: Ferring
Ionis’ ION582 Receives the US FDA’s Breakthrough Therapy Designation to Treat Angelman Syndrome
Read More: Ionis
Hengrui Pharma Enters a ~$1.08B Deal with Braveheart Bio for HRS-1893
Read More: Hengrui Pharma and Braveheart Bio
Servier to Acquire KER-0193 from Kaerus Bioscience for ~$450M
Read More: Servier and Kaerus Bioscience
Remedium Bio Joins Forces with Eli Lilly to Advance Gene Therapies for Obesity and Type 2 Diabetes
Read More: Remedium Bio and Eli Lilly
ONWARD Medical’s ARC-EX System Receives the European CE Mark Approval for Spinal Cord Stimulation
Read More: ONWARD Medical
Pulse Biosciences Receives FDA IDE Approval for nsPFA Cardiac Surgery System to Treat Atrial Fibrillation
Read More: Pulse Biosciences
Varian’s Embozene Receives the European CE Mark Approval for Use in Genicular Artery Embolisation to Treat Knee Osteoarthritis
Read More: Varian
Exact Sciences Launches Cancerguard Test for Early Multi-Cancer Detection
Read More: Exact Sciences
QIAGEN Secures CE-IVDR Certification for QIAstat-Dx Meningitis/Encephalitis Panel to Detect CNS Infections
Read More: QIAGEN
neurocare Receives the US FDA’s Clearance for Apollo TMS Therapy Devices to Treat Major Depressive Disorder in Adolescents
Read More: neurocare
Tempus AI Receives the US FDA’s 510(k) Clearance for Updated Tempus Pixel Cardiac Imaging Platform
Read More: Tempus AI
Novartis to Acquire Tourmaline Bio for ~$1.4B, Complementing its Cardiovascular Portfolio
Read More: Novartis and Tourmaline Bio
Kashiv BioSciences Collaborates with CRISTÁLIA to Commercialize ADL-018 (Biosimilar, Xolair) in Latin America
Read More: Kashiv BioSciences and CRISTÁLIA
Fangzhou Joins Forces with Innovent Biologics for AI-Driven Metabolic & Weight Management Solutions
Read More: Fangzhou and Innovent Biologics
Related Post: PharmaShots Weekly Snapshots (Sep 01, 2025 – Sep 05, 2025)