Skip to content Skip to footer
Subscribe Now

NEWS

Astellas Receives CHMP Positive Opinion for Perioperative Padcev + Keytruda for Muscle-Invasive Bladder Cancer (MIBC)
Shots: The CHMP has recommended Astellas' Padcev (enfortumab vedotin) + Keytruda for neoadj. & adj. treatment for cisplatin-ineligible pts with resectable MIBC; If approved, authorization would be valid in all 30 EEA states Opinion was based on the P-III (KEYNOTE-905/EV-303) trial, which randomized cisplatin-ineligible MIBC pts to Arm A (neoadj. & adj. Keytruda), Arm B (surgery alone), or…
May 22, 2026
Tempus AI Launches ArteraAI Prostate Test for Metastatic Prostate Cancer
Shots: Tempus AI has reported clinical launch of the ArteraAI Prostate Test (mHSPC), a CLIA-certified & CAP-accredited prognostic assay designed for pts with metastatic hormone-sensitive prostate cancer (mHSPC) ArteraAI Prostate Test (mHSPC) is an externally developed digital pathology algorithm clinically available through the Tempus AI ecosystem, with full platform integration to support personalized treatment decisions…
May 22, 2026
Polpharma Partners with Tuteur to Commercialize a Biosimilar Candidate Across LATAM for Autoimmune Diseases
Shots: Polpharma Biologics has entered into a licensing agreement with Tuteur to commercialize a biosimilar candidate for autoimmune diseases across Latin America, excl. Brazil As per the deal, Tuteur will handle commercialization, marketing, & distribution in the licensed territories, while Polpharma will be responsible for the development & manufacturing of the biosimilar candidate The biosimilar…
May 22, 2026
Merck
Merck Reports the P-III (TroFuse-005) Trial Data on Sacituzumab Tirumotecan for Advanced or Recurrent Endometrial Cancer
Shots: Merck has reported global P-III (TroFuse-005) trial data assessing sac-TMT (4 mg/kg, Q2W) vs doxorubicin/paclitaxel in 776 pts with endometrial carcinoma & carcinosarcoma who have received prior Pt-based CT & anti-PD-1/anti-PD-L1 immunotherapy either together or separately Trial met its 1EP of improved OS & PFS in the above pts, plus it also reached its key…
May 22, 2026
Medtronic Plans to Acquire SPR Therapeutics, Strengthening its Pain Portfolio
Shots: Medtronic has announced its intent to acquire SPR Therapeutics for an upfront payment of ~$650M, aiming to expand its neuromodulation portfolio with temporary peripheral nerve stimulation (PNS) tech for chronic pain management Acquisition will add SPR’s FDA-cleared SPRINT PNS System to Medtronic’s pain management portfolio, which showed over 71% pts experienced significant pain relief…
May 21, 2026
Novartis Receives the CHMP Positive Opinion of Vijoice for PROS Disorders 
Shots:  The CHMP has recommended Vijoice (alpelisib) for pts (age≥2 yrs) with severe or life-threatening PIK3CA-related overgrowth spectrum (PROS) disorders who require systemic therapy  EMA’s recommendation is supported by a retrospective study of 57 PROS pts (age≥2 yrs) treated with alpelisib through a compassionate use program. Pts achieving at least a 20% reduction in the size of 1–3 abnormal growths or tumours after 24 wks, based…
May 21, 2026
Boehringer Ingelheim
Boehringer Ingelheim Receives the CHMP Positive Opinion of Jascayd for Idiopathic Pulmonary Fibrosis (IPF) and Progressive Pulmonary Fibrosis (PPF) 
Shots:  The CHMP has recommended Jascayd (nerandomilast) for the treatment of adults with IPF and PPF  Opinion was supported by the P-III (FIBRONEER-IPF and FIBRONEER-ILD) trials; both trials met their 1EPs, showing nerandomilast slowed lung function decline vs PBO through Wk-52. Nerandomilast also demonstrated a favorable safety/tolerability profile, with no liver monitoring requirement and PBO-like discontinuation rates as monotx.   Jascayd (PO, BID) is a PDE4B inhibitor with antifibrotic and…
May 21, 2026
Load more