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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.
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"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
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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.
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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.
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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
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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
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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.
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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.
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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.
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Sales of the top 10 new drugs approved by the FDA are expected to peak at $16 billion in 2020
Time of Update: 2021-01-19
Pharmaceuticals: Pershing Mesut Ozanimod Adaptation: Peak Sales of Multiple Sclerosis: $1.598 billion March 2020, Time Inc. announced that the U.S. FDA has approved Zeposia (Ozanimod) for the treatment of adult multiple sclerosis (RMS), including clinical
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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
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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.
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The Chinese University of Science and Technology has developed a new catalyst to convert carbon dioxide into fuel
Time of Update: 2021-01-18
of work on how to reduce carbon dioxide in the air more effectively. The capture of carbon dioxide in the air has entered a phase of small-scale industrialization. Using carbon dioxide, there are also many solutions, different reduction solutions
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FDA awards MC-1 "orphan drug title" for treatment of phosphate sterol (amine) oxidase (PNPO) deficiency
Time of Update: 2021-01-18
addition, the European Medicines Agency (EMA) has awarded MC-1 the title of rare pediatric disease for the treatment of seizures associated with PNPO deficiency.
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Research and development daily Sanofi Pompeia Therapy is eligible for FDA priority review
Time of Update: 2021-01-18
journal PLoS Biology, scientists from institutions such as the Cleveland Clinic found that melatonin may be a new treatment for COVID-19. , Inc., published data from phase 1/2 clinical trials of the CoronaVac vaccine that triggers a rapid immune
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The FDA has issued industry guidelines for adding sugar to products such as honey
Time of Update: 2021-01-17
2019618,（FDA）：、、。 ,。 ：The purpose of this guidance is to provide clarification on the labeling requirements for single-ingredient packages and/or containers of pure honey, pure maple syrup, and other pure sugars and syrups, which
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The FDA's Biosynthical and Interchangeable Products Q and A Guide adds four questions and answers on interchangeability
Time of Update: 2021-01-17
to biosopass and interchangeable product development. The FDA, after considering feedback on Q and A gathered during the relevant review period and incorporating, as appropriate, changes to the Q and A recommendations, moves the finalized
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FDA approves first complementary therapy for non-small cell lung cancer with 80% reduction in disease recurrence
Time of Update: 2021-01-17
Fda approves Tagrisso (osimertinib, Osimtinib), a third-generation EGFR inhibitor developed by AstraZeneta, as the first complementary therapy to treat patients with non-small cell lung cancer (NSCLC) with specific types of gene mutations in tumors.
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FDA grants Zenotuzumab 'fast track qualification' to treat NRG1 gene fusion tumors
Time of Update: 2021-01-16
Merus is currently recruiting patients for Phase I/II clinical trials aimed at evaluating the effectiveness of Zenocutuzumab's single-drug treatment of pancreatic cancer and other solid tumors that are fusion of the NRG1 gene.
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Gene Tektronox anti-TIGIT antibody Tiragolumab has been identified by the FDA as a breakthrough therapy
Time of Update: 2021-01-16
of THE CITYSCAPE, published at the 2020 annual meeting of the American Society of Clinical Oncology (ASCO), showed an improvement in the overall remission rate (ORR of 37% vs. 21% of the risk of disease deterioration or death (no progression survival PFS
