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Bayer's Nubeqa Receives FDA Priority Review for the Treatment of mHSPC
Time of Update: 2022-05-09
Based on positive data from the Phase 3 ARASENS trial, Bayer raised Nubeqa's peak annual sales, which it expects to reach 3 billion euros .
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FDA grants Bayer's oral FXIa inhibitor asundexian Fast Track designation!
Time of Update: 2022-05-03
asundexian is an oral factor XIa (FXIa) inhibitor currently being developed as a potential drug for secondary prevention in patients with NCIS, as well as 2 other diseases: atrial fibrillation (irregular heartbeat) and recent myocardial infarction (heart attack) .
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Bayer's Factor XIa Inhibitor Stroke Clinical Program Receives U.S. FDA Fast Track Designation
Time of Update: 2022-03-04
XIa Asundexian a sundexianFast Track designation is designed to facilitate the accelerated development of drug candidates for serious diseases to address unmet medical needs, with the goal of bringing important new treatments to patients earlier .
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FDA Issues Complete Response Letter (CRL) for Somatrogon for Growth Hormone Deficiency (GHD)
Time of Update: 2022-02-18
First-line results from the pivotal Phase III trial showed that weekly Somatrogon (hGH-CTP) administered subcutaneously was non-inferior to once-daily Genotropin (hGH) .
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Huahai broke out! FDA warning letter closes, wins 5 blockbuster varieties and 10 innovative drugs
Time of Update: 2021-12-08
Recently, Huahai Pharmaceuticals announced heavy news: the southern Sichuan API base warning has been lifted, and sales in the US market are expected to resume .
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Huahai broke out! FDA warning letter closed to win 5 blockbuster varieties
Time of Update: 2021-12-08
com database, company announcement Recently, Huahai Pharmaceuticals announced heavy news: the southern Sichuan API base warning has been lifted, and sales in the US market are expected to resume .
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Huahai broke out! FDA warning letter closed to win 5 blockbuster varieties
Time of Update: 2021-12-07
Recently, Huahai Pharmaceuticals announced heavy news: the southern Sichuan API base warning has been lifted, and sales in the US market are expected to resume .
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FDA Rheumatism News: 3 new drugs have been approved, and 2 drugs have been "warned"!
Time of Update: 2021-12-05
In this issue, Wang Yuhua, director of the Department of Rheumatology and Immunology, Beijing Shijitan Hospital, Capital Medical University, took us into ACR 2021 and shared the latest news of the FDA on the safety of rheumatism treatment .
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FDA's clinical warning analysis on Oncopeptides peptide conjugate Pepaxto
Time of Update: 2021-10-11
On February 26, 2021, the FDA accelerated the approval of PEPAXTO ® (melphalan flufenamide) in combination with dexamethasone for the treatment of adult patients with relapsed or refractory multiple myeloma.
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FDA requires Pfizer/BioNTech and Moderna new crown vaccines to add label warnings
Time of Update: 2021-08-11
However, on June 24, according to foreign media reports, American experts concluded that there is a "possible link" between rare cases of cardiac inflammation and mRNA vaccines, which has brought certain harm to Pfizer/BioNTech and Moderna's vaccine injections.
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Bayer's antihistamine nasal spray Astepro receives FDA approval for over-the-counter OTC use
Time of Update: 2021-08-09
In the process of splitting its consumer health business into an independent company, GlaxoSmithKline’s Voltaren Arthritis Pain (diclofenac sodium topical gel) was approved in February last year as an over-the-counter product for adults (18 and 18 years old).
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Bayer's cell therapy for advanced Parkinson's disease obtains FDA fast-track qualification
Time of Update: 2021-07-31
The main purpose of this phase I clinical study is to evaluate the safety and tolerability of DA01 cell transplantation during the one-year period after transplantation .
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FDA warning!
Time of Update: 2021-07-30
>270 ), making it a very safe surgical anesthetic when carefully monitored; however, its efficacy requires careful measurement of highly diluted fen in solution. Tony
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FDA issues warning on GSK shingles vaccine Shingrix
Time of Update: 2021-07-14
S. Food and Drug Administration (FDA) reminded the public that the agency added the "Warnings and Precautions" section of the shingles vaccine Shingrix label to cause rare neuroautoimmune diseases The risk of Guillain-Barré Syndrome (GBS) .
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Biogen Alzheimer's FDA judgment date approaches, capital market issues warning
Time of Update: 2021-06-18
In addition to aducanumab, Biogen and its development partner Eisai Pharmaceuticals are studying another Alzheimer's disease treatment drug, which has completed the recruitment of patients for later trials .
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Biogen Alzheimer's FDA judgment date approaches capital market warning
Time of Update: 2021-06-12
Analyst Iuri Struta said in the study that Biogen lacks preparation for the patent cliffs of the three key multiple sclerosis drugs Tysabri, Tecfidera and Vumerity.
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K drug treatment of high-risk early triple-negative breast cancer encounters a complete response letter from the US FDA
Time of Update: 2021-04-19
The sBLA seeks to approve Keytruda for the treatment of high-risk early triple-negative breast cancer (TNBC) patients, specifically: Keytruda combined with chemotherapy for neoadjuvant (preoperative) treatment, and then Keytruda as a single drug for adjuvant (postoperative) treatment.
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The Mercadon/Bayer heart failure drug Vericiguat has been approved by the FDA
Time of Update: 2021-03-10
patients with a medium follow-up period of 10.8 months showed that the Vericiguat treatment group reduced the risk of compound endpoint death from heart failure hospitalization and cardiovascular causes (35.5% vs.
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The FDA has approved Bayer nubeqa ® for the treatment of patients with adenocarcinoma
Time of Update: 2021-02-24
today, Bayer announced FDA approval for Nubeqa® (darolutamide) for the treatment of patients with non-metastatic desopathic prostate cancer (nmCRPC).
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Bayer received FDA approval for Gadavist
Time of Update: 2021-02-24
the U.S. Food and Drug Administration (FDA) has approved Bayer's Gadhavist as the first and only heart magnetic resonance imaging (CMRI) agent for patients with coronary artery disease. The injection has been approved
