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Approved under the regulator’s accelerated pathway, Tecelra is also the first new synovial sarcoma therapy in more than a decade, according to Adaptimmune Therapeutics.

In pursuit of Merck’s blockbuster Keytruda, GSK’s Jemperli scored its own broad FDA label expansion, allowing its use in first-line endometrial cancer regardless of biomarker status.

As part of a major reorganization, Vir Biotechnology has discontinued the bulk of its virology work and pivoted to cancer in an exclusive licensing deal with Sanofi.

Poor efficacy data for two early-stage candidates for the rare disease alpha-1 antitrypsin deficiency have convinced Vertex Pharmaceuticals to terminate their development.

Moderna’s stock price plunged more than 20% in Thursday morning trading after the company lowered its 2024 revenue guidance due to weak demand for its coronavirus vaccine in the second quarter.

With an upfront $800 million payment and $325 million in potential milestones, Otsuka Pharmaceutical is acquiring Jnana Therapeutics’ drug discovery platform and rare disease candidate, the companies announced Thursday.

Eli Lilly on Thursday released late-stage data showing a 38% reduction in the risk of heart failure outcomes, as it plays catch-up with Novo Nordisk’s semaglutide which won the FDA’s cardio nod in March.

The Genetic Metabolic Diseases Advisory Committee will meet on Friday to discuss Zevra’s modified scale to describe the efficacy of its drug candidate for the treatment of Niemann-Pick disease type C.

Reiterating his ruling in a prior Inflation Reduction Act case, New Jersey District Court Judge Zahid Quraishi ruled that Novo Nordisk’s participation in the Medicare Drug Price Negotiation Program is of its own free will.

Sarepta has been hit with another patent infringement lawsuit, this time from Sanofi and its subsidiary Genzyme alleging that the biotech used protected technology related to AAV vectors.

Generative AI could enhance and accelerate the way people work on clinical trials. In this Q&A, a management consultant shares his insights on benefits, risks and more.

In this episode, Lori and guests discuss the pursuit of adequate representation and how clinical trials are being shaped by the legal environment they operate within.

66.6% of OST-HER2 treated patients achieved 2-year overall survival compared with 40% in the historical control group (p = 0.0046) FDA issues Biologics Licensing Application (BLA) number for OST-HER2 in preparation for anticipated BLA filing for the prevention or delay of recurrent, fully resected, pulmonary metastatic osteosarcoma following August 27, 2025 End of Phase 2 Meeting Company responds to FDA correspondences seeking to align approval metrics for Regenerative Medicine Advanced Therapy (RMAT) designation, Breakthrough Therapy designation (BTD) and Biologics Licensing Application via Accelerated Approval Program Company’s NYSE American listing included in the Russell Microcap, Russell Microcap Value and Russell Microcap Growth indexes

MHRA seeks to harmonize UK & US regulatory review via Project Orbis EMA Rapporteur Scientific Advice Meeting scheduled for October 2025

Investment accelerates Maxwell’s path toward FDA trials and global market readiness