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Gilead
NEWS

Gilead Reports the US FDA Accelerated Approval of Hepcludex to Treat Chronic Hepatitis Delta Virus (HDV) Infection

Shots: The US FDA has granted accelerated approval for Gilead’s Hepcludex (bulevirtide-gmod; 8.5mg) for the treatment of adults with chronic HDV infection Approval was based on the P-III (MYR301) trial assessing Hepcludex (QD, SC) for 144wks. in pts living with HDV, followed by 96wks. of off-treatment follow-up Trial showed significant improvements in HDV RNA reduction & ALT…
May 25, 2026

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Boehringer Ingelheim
NEWS

The NMPA Grants Conditional Approval to Boehringer Ingelheim’s Hernexeos for 1L HER2-Mutant NSCLC

Shots: The NMPA has granted conditional approval to Hernexeos (zongertinib) for initial treatment of adults with unresectable, locally advanced, or metastatic NSCLC harboring HER2 (ERBB2) tyrosine kinase domain-activating mutations Approval was based on the data from a treatment-naïve cohort (N=74) of P-Ib (Beamion LUNG-1) trial assessing Hernexeos as monotx., which showed improved ORR of 75.7% (10.8%…
May 22, 2026

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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

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NEWS

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

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NEWS

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

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Merck
NEWS

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

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NEWS

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

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