[11/1/2024] FDA is warning patients and health care professionals not to use drugs compounded and distributed by Fullerton Wellness LLC, Ontario, ... ...

[1/16/2025] FDA is warning health care professionals not to use unapproved epinephrine nasal solutions manufactured by BPI Labs LL...

[9/18/2024] FDA is warning consumers and health care professionals not to use SnoreStop Nasal Spray, distributed by Green Pharmaceuticals Inc. ...

　　For the implementation of the "supervision and management of medical devices regulations", the full implementation of medical device registrants (hereinafter referred to as the registrant) quality and safety of the main responsibility to further strengthen the registrant entrusted to the supervision and management of the production, and effectively prevent and control the risk of medical device quality and safety. Now on the relevant matters announced as follows: First, the strict implementation of the main responsibility of medical device registrants (a) registrants should fully implement the main responsibility for the quality and safety of medical devices, the establishment of a...

　　In 2024, the State Drug Administration adhered to Xi Jinping's thought of socialism with Chinese characteristics in the new era as a guide, fully implemented the 20th CPC National Congress and the spirit of the 2nd and 3rd Plenary Sessions of the 20th CPC Central Committee, implemented the requirements of the "four most stringent", in accordance with the work idea of "political, strong supervision, safety, development and people's livelihood. In accordance with the working idea of "speaking politics, strengthening supervision, ensuring safety, promoting development and benefiting people's life", integrating high-quality development and high-level safety, the standardization work of medical devices has stepped up to a new level, and the high standard has helped the scientific supervision of medical devices, promoted technological innovation, and led to the...

Today, Genentech, a Roche company, announced that a detailed analysis of REGENCY, a Phase 3 clinical trial of the anti-CD20 antibody therapy Gazyva (obinutuzumab) for the treatment of patients with active lupus nephritis, has been published in the New England Journal of Medicine. The data showed that Gazyva, in combination with standard therapy, met the trial's primary endpoint, significantly improving patients' complete renal remission...

On February 6, Bristol-Myers Squibb (BMS) revealed its decision to terminate the development of Cendakimab, an IL-13 monoclonal antibody that has entered Phase III, during the release of its 2024 results.Cendakimab is no longer visible in the PPT of BMS's 2024 annual report. In response, Adam Lenkowsky, Chief Commercial Officer of BMS, explained, "Given the available data, we have decided to abandon the development of Cendakim...

On February 7, 2025, Novo Nordisk announced updated data from FRONTIER3, a Phase III clinical trial of the FIX/FX dual antibody Min8 for the treatment of childhood hemophilia A. The study was divided into two parts, with the first part receiving 26 weeks of weekly treatment and the second part, the remaining 26 weeks being switched to once-monthly or maintenance weekly treatment. For the first part, the mean annualized bleeding rate (ABR) was 0.53, with a median ABR of 0. 45...

On February 6, 2025, Merck Sharp & Dohme announced the initiation of a pivotal Phase III clinical trial of the new ROR1 ADC drug Zilovertamab Vedotin in combination with R-CHP against R-CHOP for the first-line treatment of diffuse large B-cell lymphoma (DLBCL). WaveLINE-010 is planned to enroll 1,046 patients with DLBCL, with the primary endpoint being PFS and secondary endpoints including CR rate, OS, EFS, C...