FDA has granted Emergency Use Authorization to Seegene USA's Allplex multiplex PCR assay, making it the first U.S.-authorized test to simultaneously detect and differentiate HSV-1, HSV-2, VZV, and ...

Gerren McHam, vice president of Government and External Affairs, API Innovation Center, describes how China’s recent export control updates may introduce new vulnerabilities for ...

FDA IND clearance enables U.S. site activation for the ongoing Phase I C-1101-101 trial, with initial dosing already completed in Australia and near-term plans to begin treating U.S. patients. C-1101 ...

David Hung, president, CEO, and founder of Nuvation Bio, discusses his leadership style, emphasizing the importance of hiring ...

Viral surveillance and predictive modeling are used to map mutational escape pathways and inform proactive antibody design against likely future variants rather than only current circulating strains.

Indication includes adults with hypercholesterolemia, including heterozygous familial hypercholesterolemia, for LDL-C ...

Kp-104 (vensobafusp alfa) advances as a Phase II/III-ready bifunctional complement biologic targeting alternative and terminal pathways, with rare renal Phase II basket interim reads in Q4 2026 and Q2 ...

Consideration includes $6.75/share upfront cash and up to $2.50/share CVRs, implying ~$3.8B total value and ~40% premium to the 30‑day VWAP. BPL‑003 (intranasal mebufotenin benzoate/5‑MeO‑DMT) targets ...

Traditional approval was anchored on eGFR preservation rather than proteinuria surrogate, strengthening linkage to dialysis/transplantation risk reduction. APPLAUSE-IgAN showed a 2.7 mL/min/1.73 ...