. After the acceptance, the FDA will review the application materials of Cinda Biologics, conduct on-site verification, and finally determine whether to approve it .
The FDA approved the listing of a new drug aducanumab for Alzheimer's disease, but it led to the resignation of three experts. Why?
Time of Update: 2021-06-30
Based on the phenomenon of β-amyloid deposits in the brains of AD patients, researchers have launched a large number of studies in an attempt to find specific drugs for the treatment of Alzheimer's disease.
New drug listing adventures: Who is the FDA's compromise for?
Time of Update: 2021-06-28
Recently, the US Food and Drug Administration (FDA) announced that it has accelerated the approval of the new drug Aducanumab (trade name Aduhelm) developed by Biogen for the treatment of Alzheimer's disease, but this decision caused an uproar .
U.S. FDA Approval of Listed Drugs and my country's Domestic Application Status in the First Quarter of 2021
Time of Update: 2021-06-08
of these two types of enterprises is far ahead and ranked below. In the first echelon of the same category, 280 domestic companies have approved drugs for the digestive tract and metabolism, 214 drugs for the nervous system, and 210 drugs
U.S. FDA approval of listed drugs in the first quarter of 2021 and my country's domestic application status
Time of Update: 2021-06-06
/> The number of these two types of enterprises is far ahead and ranked below. In the first echelon of the same category, 280 domestic companies have approved drugs for the digestive tract and metabolism, 214 drugs for the nervous system, and 210
The US FDA grants Legendary Biologics BCMA CAR-T priority review qualification, which is expected
Time of Update: 2021-06-05
May 28, 2021/MedClub News/--Legendary Bio announced that the US FDA has accepted its BCMA CAR-T cell therapy ciltacabtagene autoleucel ( cilta-cel) Priority review of the Biological Agent License Application (BLA), the PDUFA date has been confirmed as November 29, 2021.
Wanchun Pharmaceutical's U.S. listing application for pranabulin was granted priority review by FDA
Time of Update: 2021-06-04
Article source: Medical Rubik's Cube Info>On June 1, Wanchun Medicine announced that its core product "Punablin Concentrate Solution for Injection" for use
TG Therapeutics' third-generation CD20 monoclonal antibody listing application was accepted by the U.S. FDA | Yimai Meng broke the news
Time of Update: 2021-06-01
There are B lymphocyte surface antigen B1, Bp35, leukocyte surface antigen Leu-16, transmembrane 4-domain subfamily A member 1, etc. The protein function may be involved in regulating B cell activation and proliferation
FDA Issues Guidance for Non-clinical Research of Individualized Antisense Oligonucleotide Therapeutics
Time of Update: 2021-05-22
Debilitating or Life-threatening Diseases", introducing support for research on individualized antisense oligonucleotides Non-clinical information recommended by the FDA for Sexual New Drug Application (IND). > FDA Acting
Only 5% of clinical trials of new coronary therapies can give guidance? The acting director of the FDA co-issued a joint message
Time of Update: 2021-03-24
Time of Update: 2021-02-24
Talicia is an FDA-approved helicobacter pyridobacteria removal therapy based on rifabutin designed to address helicobacter pyridosis resistance to antibiotics commonly used in standard care therapies.
Baiji Shenzhou BTK inhibitor Zebutini new adaptive disease listing application was accepted by the FDA
Time of Update: 2021-02-24
On February 17, Baiji Shenzhou announced that the U.S. FDA had accepted a new application (SNDA) for the treatment of patients with Fahrenheit globulinemia (WM), with the PDUFA dated October 18, 2021.
Fda approves the listing of the ruzurgi (amifampridine) pill
Time of Update: 2021-02-16
ruzurgi was based on a randomized double-blind, placebo-controlled clinical study of 32 adult patients.
FDA approves Pfizer's third-generation APK inhibitor for listing
Time of Update: 2021-02-14
On November 3rd Pfizer announced that the FDA had approved the launch of the third generation of ALC Tyrosine kinase inhibitor (TKI) Lorlatinib for the treatment of ALC-positive metastasis non-small cell lung cancer (NSCLC) patients.
The Drug Administration issued a document to provide guidance for the control of nitrosamine impurities
Time of Update: 2021-02-13
(Draft for Comments), and is now open to public consultation. According to the Draft, since July 2018, N-nitrodiamine (NDMA) has been detected in other sartan-type API drugs, such as NDMA, N-Nitrodythylamine (NDEA) and so
The application for the listing of baiva bead monobial-like drugs was accepted by the FDA
Time of Update: 2021-02-01
Source: Pharmaceutical Mission, January 28, Baotai Bio issued a press release saying that the FDA has accepted the BAT1706 (Beval pearl monobial-like drug) injection biological products market application (BLA), the adaptation of the application
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.
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.