China Paint Network News: districts (cities) county quality supervision bureau (market supervision bureau), all relevant enterprises: in order to ensure consumer safety, in the first half of 2015, our bureau on paint
The FDA sent a full response letter to Sanofi sutimlimab rejecting its listing application
Time of Update: 2021-01-21
Compiled on November 14, the FDA issued a full response letter regarding the application for permission for Sanofi supplement C1s inhibitor Sutimlimab biologics.
"Pharmaceutical Express" Hengrui SHR-1314 approved clinical FDA delayed liso-cel listing application
Time of Update: 2021-01-20
November 17, 2020 / Medical Information At a Glance: Schweija China Operations Director Robert Lo is leaving; FDA again postpones liso-cel listing application; East China Pharmaceutical Injection sodium sodium is evaluated; Hengrui SHR-1314
From two public documents, the FDA and medical experts debate the withdrawal of preshedoning drugs
Time of Update: 2021-01-20
Last month, it was reported that the U.S. FDA had proposed withdrawing accelerated approval for makena, amAG Pharmaceuticals' premaconceive prevention drug. AMAG filed a request not to accept the FDA's withdrawal proposal and called
Supplement C3 inhibitor listing application is FDA priority review! Challenge the heavy drug Ikuzhu monoantigen
Time of Update: 2021-01-20
data also showed a higher rate of normalization of hemolytic symptoms in the pegcetacoplan group, and a clinically significant improvement in the chronic disease treatment function assessment (FACIT)-fatigue score.
Pfizer's third-generation APK inhibitors are eligible for FDA priority review; AstraZenecom's new
Time of Update: 2021-01-20
FDA approval, the company will jointly develop and commercialize relugolix compound tablets in the United States and Canada for the treatment of diseases in women's health.
Transparency brings trust: Fda announces disclosure of review information used to support emergency use authorizations
Time of Update: 2021-01-20
The U.S. FDA issued a circular on November 17 promising to publicly disclose scientific data and other review information used to authorize, revise, or revoke the Authorization for Emergency Use of Drugs (EUA). FDA Director Stephen Hahn said
New antipsychotic drugs! ALKS3831 (Otspin/samidorphan) has been re-accepted by the FDA: Treatment of Schizophrenia/Biphasy Type I Disorder
Time of Update: 2021-01-20
ENLIGHTEN-1 is a 4-week randomized, double-blind Phase III study conducted in patients with schizophrenia who are experiencing acute exacerbation, comparing the antipsychotic efficacy, safety and tolerance of APKS3831 relative to placebo.
The FDA Director issued a statement expressing his commitment to maintaining the transparency of coVID-19's emergency use authorization
Time of Update: 2021-01-20
I would like to take a moment to reaffirm the FDA's commitment to transparency in the EUA process and provide more information about the FDA's decision to release, revise or withdraw EUA for pharmaceutical and biological products, including vaccines.
These five FDA approval decisions in the first quarter of 2021 deserve attention in the areas of Mercadon, Bayer...
Time of Update: 2021-01-19
and is expected to make a decision by the end of March on heart failure drugs, new dousing muscular dystrophy drugs and cancer cell therapy drugs.
Asasin Pharma has been certified as an FDA orphan drug, with a total of 9 chinese pharmaceutical companies in 2020
Time of Update: 2021-01-19
, as of now, Asah Pharmaceuticals has obtained 9 FDA orphan drug certifications in research and development of new drugs, the largest number of Chinese enterprises.
Due to process conditions, the potentially heavy drug Ao nitrogen flat compound was delayed by the FDA approval
Time of Update: 2021-01-19
On Tuesday, NASDAQ-listed Company Alkermes announced that it had received a letter from the U.S. Food and Drug Administration (FDA) on its new drug, APKS 3831 (Ao nitrogenpine/samidorphan), for adults with schizophrenia and bisomethic type I disorders.
The FDA issued 34 product-specific guidelines for the first oral botany BE recommendation
Time of Update: 2021-01-19
drugs. FDA's guidelines provide recommendations for the identification and quality assessment of plant raw materials (BRM), recommendations for API similarity, recommendations for bioethics (research type is clinical endpoint biological
