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Threshold for oncology drug development is raised: FDA pays attention to clinical trial dose design
Time of Update: 2021-09-20
Recently, the agency is launching the Optimus project of the FDA Oncology Center of Excellence, which will develop new guidelines for cancer drug manufacturers to explore a wider range of doses in early trials .
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Boyage completes first patient enrollment due to CRISPR/Cas9 gene editing therapy
Time of Update: 2021-09-10
Text|Pharmaceutical Mission HillsOn September 8, Boya Gene announced that its subsidiary Guangzhou Gene has a multi-center phase 1 registered clinical trial of the hematopoietic stem cell gene editing therapy product ET-01 for blood transfusion-dependent β-thalassemia.
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Jianyou shares: Daptomycin for injection has been approved by the US FDA for drug registration
Time of Update: 2021-08-16
On June 30, Jianyou shares announced that its subsidiary Hong Kong Jianyou recently received daptomycin for injection, 500mg/bottle (ANDA number: 213623), 350mg/bottle (ANDA number: 213786) issued by the US Food and Drug Administration.
Letter of approval .
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New indication for AstraZeneca dovalizumab is about to be approved in China
Time of Update: 2021-08-16
According to the official website of China's National Food and Drug Administration, AstraZeneca's blockbuster PD-L1 inhibitor durvalumab injection (durvalumab, trade name: Imfinzi) has a new indication for the market.
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Following Pfizer, Merck's new pneumonia vaccine was approved by the FDA
Time of Update: 2021-08-03
Pfizer’s new vaccine protects against more than 7 more pathogens than the 10-year-old Prevnar 13-valent vaccine.
At the same time, Merck will continue to sell its 38-year-old pneumococcal 23-valent vaccine, which can prevent 23 strains and is approved for use in children .
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Nanchang Market Supervision Administration Announcement on Food Sampling Inspection Information in 2021 (No. 23 of 2021
Time of Update: 2021-08-02
In accordance with the " Food Safety Law of the People's Republic of China " and other relevant regulations, the information on the food safety inspections recently carried out by our bureau is now
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Guangzhou Municipal Market Supervision Administration Phase 7 Food Safety Supervision Sampling Inspection Information in 2021
Time of Update: 2021-05-08
html" class="zdbq" title="Manage related food information" target="_blank">management bureau of the city's production and operation of 10 major categories foodmate.
html" class="zdbq" title="Manage related food information" target="_blank">management bureau of the city's production and operation of 10 major categories foodmate.
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Xinlitai SAL0104 Capsule was approved to carry out clinical trials for the prevention and treatment of thrombotic diseases
Time of Update: 2021-04-14
SAL0104 capsule is a coagulation factor XIa inhibitor, and its intended development indication is the prevention and treatment of thrombotic diseases.
Compared with similar products, coagulation factor XIa inhibitors can reduce the incidence of thrombosis and at the same time have the characteristics of low bleeding risk.
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Yangtze River Health: The State Food and Drug Administration agrees to change the holder of the marketing license for caspofungin acetate for injection
Time of Update: 2021-03-27
On March 18, the Yangtze River Health announced that the State Food and Drug Administration agreed that caspofungin acetate for injection (drug approval number: Sinopharm Zhunzi H202003001, Sinopharm Zhunzi H202003002, specifications 50mg, 70mg) drug marketing license holders "Borui Pharmaceutical (Suzhou) Co.
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The color of the dairy products
Time of Update: 2021-02-13
The Center for Science in the Public Interest says Danon's behavior deceives consumers that they expect real fruit, not the color provided by insects , 's source of sebum red extract .
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Notice of the Chongqing Municipal Market Supervision Administration on special sampling of food during the 375 batch outbreak (No. 6 of 2020
Time of Update: 2020-11-29
During the epidemic prevention and control period, in order to ensure the safety of the people's diet, the Chongqing Municipal Market Supervision and Administration carried out special supervision and sampling of key foods such as rice noodle oil, meat, egg milk, fruits and vegetables and fresh aquatic products.
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Regenerative Element and Reding Pharmaceuticals develop REGN1979 (CD20xCD3 bispecific antibody) for the treatment of non-Hodgkin's lymphoma
Time of Update: 2020-06-24
Regeneron and Zai Lab announced a strategic partnership to develop and commercialize REGN1979 (CD20xCD3 dual-specific antibodies) in Chinese mainland, Hong Kong, Taiwan and Macau This partnership wi
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The State Drug Administration accepts a new drug application for the treatment of set cell lymphoma in Zanubrutinib, Baiji Shenzhou
Time of Update: 2020-06-11
lymphoma is a group of malignant tumors that originate in B cells, T cells, or NK cells Set cell lymphoma (MCL) is usually an invasive non-Hodgkin's lymphoma (NHL) that originates from B cells in th
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FDA approves Pfizer Ruxience for adult patients to treat a wide range of diseases
Time of Update: 2020-06-09
recently, Pfizer announced that the U.S Food and Drug (http:// Administration ( FDA (http:// ) has approved Ruxience (rituximab-pvvr, ritusxixipro, rituxixixim) for the treatment of adult patie
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China's listed drug database, can be checked in this way
Time of Update: 2020-05-13
REVIEW: "China Listed Drug Database" multi-function screening, intelligent multi-dimensional analysis of accurate, detailed and comprehensive information quickly and easily understand the drug After when analyzing a company listed for Drug Evaluation, do you spend most of their time doing data export analysis reports it?
