Skip to content Skip to footer
Subscribe Now
Daiichi Sankyo
NEWS

Daiichi Sankyo Reports the EMA’s MAA Acceptance of Enhertu + Perjeta to Treat HER2 Positive Metastatic Breast Cancer

Shots: The EMA has validated the Type II Variation MAA for Enhertu (trastuzumab deruxtecan) in combination with pertuzumab for the 1L treatment of patients with HER2+ positive unresectable or metastatic breast cancer. MAA was supported by P-III (DESTINY-Breast09) trial data on Enhertu (5.4mg/kg) ± Perjeta vs taxane, trastuzumab & Perjeta (THP) in HER2+ metastatic breast cancer…
January 19, 2026

Read more

Telix Pharmaceuticals
NEWS

Telix Reports First US Patient Dosing in the P-III Trial of Illuccix and Gozellix, for the Diagnosis of Prostate Cancer

Shots: The company has reported dosing of the first patient in the US  P-III (BiPASS) trial evaluating its PSMA-PET imaging agents, Illuccix and Gozellix, for use in the initial diagnosis of prostate cancer BiPASSa P-III study enrolling 250 pts in the US and Australia to support marketing authorization of 68Ga-PSMA-PET in the pre-biopsy setting Building…
January 19, 2026

Read more

NEWS

D3 Bio Receives the US FDA IND Clearance to Initiate P-I trial of D3S-003 & P-II Combination Study of Elisrasib (D3S-001) with D3S-002

Shots: FDA has granted IND clearance to initiate D3S-003 a P-I, and a P-II combination study of D3S-001 (elisrasib), a next-gen KRAS G12C inhibitor, with D3S-002, an oral ERK1/2 inhibitor The P-II trial will evaluate the D3S-001 + D3S-002 combination in KRAS G12C–mutant NSCLC patients who have progressed on prior KRAS G12C therapies to assess…
January 19, 2026

Read more

NEWS

Boston Scientific to Acquire Penumbra for ~$14.5B

Shots: Boston Scientific has entered into a definitive agreement to acquire Penumbra, expanding its cardiovascular portfolio As per the deal, Boston Scientific will acquire Penumbra for $374/share, with Penumbra stockholders having the option to receive either $374 in cash or 3.8721 shares of Boston Scientific’s common stock, representing the enterprise value of ~$14.5B; closing expected…
January 16, 2026

Read more

NEWS

Agenus Completes Strategic Collaboration with Zydus Lifesciences of ~$141M to Advance BOT+BAL Development & Expand US Manufacturing

Shots: Agenus has completed its strategic collaboration with Zydus Lifesciences to accelerate global development and potential commercialization of the BOT+BAL immunotherapy program As per the deal, Zydus gave $75M upfront payment to Agenus for US biologics manufacturing facilities, and Agenus is also eligible for Contingent Milestone Payments ~$50M in production-linked milestones. Zydus acquired common stock…
January 16, 2026

Read more

NEWS

Santhera Pharmaceuticals Reports Swissmedic’s Approval of Agamree (Vamorolone) to Treat Duchenne Muscular Dystrophy

Shots: Swissmedic has approved Agamree for the treatment of pts (≥4yrs) with Duchenne muscular dystrophy and expects launch in H2’26 Approval was based on pivotal P-IIb (VISION-DMD) data and EMA assessments, granting 15-year Swiss orphan drug exclusivity; Santhera retains exclusive Swiss distribution. Trial met its 1EP of Time to Stand (TTSTAND) velocity vs PBO at…
January 15, 2026

Read more

Sanofi
NEWS

Sanofi Secures China Approval for Myqorzo and Redemplo in oHCM and FCS

Shots: China’s NMPA has approved Sanofi-licensed Myqorzo (aficamten) for the treatment of obstructive hypertrophic cardiomyopathy (oHCM) and Redemplo (plozasiran) for triglyceride reduction in adults with familial chylomicronemia syndrome (FCS) on dietary control The approval of Myqorzo was based on the pivotal P-III (SEQUOIA-HCM) study in pts with symptomatic oHCM, while Redemplo’s approval was supported by…
January 15, 2026

Read more

NEWS

Emergent BioSolutions Receives US FDA Approval of sNDA for NARCAN Nasal Spray with New Carrying Case to Reverse Opioid Overdoses

Shots: The US FDA has approved Emergent BioSolutions’ supplemental NDA (sNDA) for over-the-counter (OTC) NARCAN Nasal Spray to be packaged in a new, compact carrying case designed to improve portability and everyday preparedness The new carrying case includes two blister-packed doses with a Quick Start Guide and is intended to increase accessibility, discretion, and likelihood…
January 15, 2026

Read more

NEWS

ImmunityBio Reports Positive Clinical Results of ANKTIVA Plus Checkpoint Inhibitors in NSCLC

Shots: ImmunityBio announced positive results from two clinical studies evaluating ANKTIVA (nogapendekin alfa inbakicept) in combination with checkpoint inhibitors (CPI) in non-small cell lung cancer (NSCLC), demonstrating statistically significant immune restoration across 151 pts In 1L NSCLC, the randomized QUILT-2.023 study showed a significant and sustained increase in absolute lymphocyte count (ALC) with ANKTIVA +…
January 15, 2026

Read more

Load more