Skip to content Skip to footer

Astellas and Pfizer Gain FDA Priority Review for Padcev + Keytruda in Muscle-Invasive Bladder Cancer (MIBC), Regardless of Cisplatin Eligibility

Shots: The US FDA has accepted sBLA & granted priority review to perioperative Padcev + Keytruda/Keytruda Qlex for the treatment of pts with MIBC, regardless of cisplatin eligibility (PDUFA: Aug 17, 2026) sBLA was supported by the P-III (EV-304/KEYNOTE-B15) trial assessing neoadj. Padcev + Keytruda, followed by surgery & then adj. Keytruda + Padcev vs…

Read more

Eli Lilly to Acquire Kelonia Therapeutics for ~$7B

Shots: Eli Lilly has entered into a definitive agreement to acquire Kelonia Therapeutics, expanding Lilly’s genetic medicine capabilities As per the deal, Lilly will acquire Kelonia for ~$7B in cash, incl. $3.25B upfront, & additional clinical, regulatory & commercial milestone payments; closing expected in H2’26 Acquisition will add Kelonia’s in vivo gene placement system (iGPS0) & its lead asset, KLN-1010, a one-time IV…

Read more

Aligos Therapeutics Licenses Pevifoscorvir Sodium to Xiamen Amoytop Biotech for Greater China

Shots: Aligos has entered into an exclusive license agreement with Xiamen Amoytop Biotech, granting Amoytop rights to develop & commercialize pevifoscorvir sodium in Greater China for chronic hepatitis B virus (HBV) infection As per the deal, Aligos will receive an $25M upfront & ~$420M in clinical, regulatory, & sales milestones along with tiered, high single-digit…

Read more

Interna Therapeutics Collaborates with Daiichi Sankyo to Develop MNM-Based Targeted Delivery Technologies

Shots: Interna has entered into a research collaboration with Daiichi Sankyo via its Daiichi Sankyo Research Institute Boston to evaluate its MNM technology as a delivery enhancer for targeted therapeutic modalities As per the deal, the companies will integrate MNM molecules with targeting approaches to enhance intracellular delivery & therapeutic performance, initially focusing on preclinical…

Read more

CareDx to Divest Lab Products Unit to EuroBio Scientific for $170M

Shots: CareDx has entered a definitive agreement to divest its Lab Products business, incl. PCR & NGS-based transplant diagnostics, to EuroBio Scientific for $170M in cash  Divestiture aims to streamline operations and refocus on core Precision Medicine Testing Services and digital solutions, while retaining exclusive North America rights to distribute post-transplant monitoring IVD tests, incl. AlloSeq…

Read more

AOP Health Reports the US FDA Approval Rapiblyk (Landiolol) for Pediatric Patients with Supraventricular Tachycardia

Shots: The US FDA has approved Rapiblyk (landiolol) for use in pediatric pts (from birth to <18 years of age) with supraventricular tachycardia (SVT), expanding its use beyond adults Approval was supported by the LANDI-PED study (n=60), which showed >20% reduction in ventricular rate, demonstrating clinically meaningful heart rate control in this patient subgroup Rapiblyk…

Read more