Rare Disease Therapies Gain Momentum With Regulatory Support and Continued Market Growth
The landscape for rare disease treatments appears to be evolving rapidly, thanks to a confluence of regulatory momentum and a booming market forecast. Statements from key federal figures in recent...
Zydus Lifesciences in Discussions to Acquire Majority Stake in Amplitude Surgical for €256.8m ($277.4m)
Zydus Lifesciences Limited announced on March 11, 2025, that it entered into an agreement to acquire a majority stake in Amplitude Surgical. Reports state that Zydus Lifesciences has a tender offer agreement with PAI Partners,...
End of an Era: The After Final Consideration Pilot Program 2.0 Concludes
The sun is officially setting on the United States Patent and Trademark Office’s (USPTO) After Final Consideration Pilot Program 2.0 (AFCP 2.0)[1]. This program, which has been instrumental in facilitating...
FDA Dataset Helps Firms Scrutinize Third-Party Chemistry Labs
Medical devices that contact the human body undergo biocompatibility safety assessments prior to market release, including tests for physiochemical properties. The Food and Drug Administration’s (FDA) Center for Devices and Radiological Health (CDRH) recently released a dataset to assist medical device firms in this process. The information addresses capabilities of third-party analytical chemistry labs.
The First FDA Approved, Chinese Developed, PD-1 Inhibitor For Nasopharyngeal Carcinoma
On October 27th, 2023, the U.S. Food and Drug Administration (FDA) approved LOQTORZITM (toripalimab-tpzi), developed by Coherus BioSciences, Inc., and Shanghai Junshi Biosciences Co., Ltd., for two indications: 1) in...
