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The FDA approved AstraZeneatic and Enhertu for stomach adenocarcinoma
Time of Update: 2021-01-22
The FDA said recently that it has expanded the range of adaptations to AstraZeneta (fam-trastuzumab deruxtecan-nxki) to include locally advanced or metastatic HER2-positive gastric or gastroesophageal (GEJ) adenocarcinoma, which has previously been treated with tricoporosis.
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Innovative neurostitulation therapy for Alzheimer's disease has been recognized by the FDA as a breakthrough medical device
Time of Update: 2021-01-22
The FDA's Breakthrough Medical Device Program is designed to help patients gain more timely access to innovative technologies that can provide more effective treatment or diagnosis of life-threatening or irreversible debilitating diseases.
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FDA approves Bayer Nubeqa prescription information update: Phase 3 clinical significantly extended lifetime
Time of Update: 2021-01-22
data show that nubeqa significantly reduced the risk of death by 31% and extended the survival of patients with non-metastatic desopathic prostate cancer (nmCRPC) compared to placebo.
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Targeted complement signaling pathrapies Innovative antibody therapies are eligible for FDA priority review
Time of Update: 2021-01-22
Demopulos, Chairman and CEO of Omeros, said, "There are currently no FDA-approved products for the treatment of HSCT-TMA, a common and fatal complication of stem cell transplantation.
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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.
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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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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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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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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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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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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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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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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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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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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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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'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
