, the U.S. Food and Drug Administration approved the first diagnostic test for taking patient samples at home to test COVID-19 influenza A and B. FDA Authorized Quest Diagnostics RC COVID-19 and Flu RT-PCR
Sanofi Rilzabrutinib is eligible for the FDA Fast Track
Time of Update: 2021-03-05
In terms of ITP therapeutic drugs, Nplate (romiplostim) is the first FDA-approved drug to treat ITP, a platealine-producing analog peptide that opens up new avenues for long-term treatment of this chronic disease by increasing and maintaining plate concentrations.
Junshi Ripley single resistance was approved for Phase III clinical overlay by fda fast track eligibility overlay
Time of Update: 2021-03-05
treatment in patients with mucosal melanoma was also approved by the FDA. The first approved domestic PD-1 single anti-2018 December 2018, Junshi biotrepri single anti-injection in china obtained the conditional approval of NMPA listing
Innovative medicine for acute migraines! FDA accepts nasal drug methyl sulfonate dehydroquine amine
Time of Update: 2021-03-05
the drug was developed using Impel's proprietary Precision Olfactory Delivery (POD) technology and delivered directly to the blood vessel-rich upper nasal cavity, potentially providing convenience and clinical benefits for patients with acute migraines.
The FDA stopped Voyager gene therapy to treat Huntington's disease
Time of Update: 2021-03-05
Later on Tuesday, Cambridge, Massachusetts-based Voyager announced that the FDA had issued a clinical stay on its application for a new drug (IND) for the company's gene therapy VY-HTT01 for huntington's disease.
FDA approves first drug to treat rare metabolic disorders
Time of Update: 2021-03-05
The U.S. Food and Drug Administration today approved Oxlumo as the first treatment for type 1 primary oxalic aciduria (PH1), a rare genetic disorder.
Advanced kidney cancer "immune and targeted" first-line treatment! The Opdivo-Cabometyx program was approved by the FDA and beats Sutt!
Time of Update: 2021-03-04
weeks, and Cabometyx is given 40 mg tablets oral once a day. the Opdivo and Cabometyx "Immune plus Targeting" combinations have been approved through the Priority Review Program and the Real-Time Oncology Review (RTOR) pilot project for all
New medicine for rare lung disease! Roche Esbriet (pyridone) is reviewed by the FDA as a priority
Time of Update: 2021-03-04
phase II clinical trial data show that Esbriet slowed the progression of the disease in UIDD patients at 24 weeks of treatment compared to a placebo.
First lupus nephritis (LN) oral drug! Lupkynis, the best-in-class calcium-adjusted neurophosphatase inhibitor, has been approved by the FDA!
Time of Update: 2021-03-04
recently, the company announced that the U.S. Food and Drug Administration (FDA) has approved Lupkynis (voclosporin), a joint background immunosuppressive therapy for the treatment of active lupus nephritis (LN) adult patients.
The combination of the two immunotherapy combinations of Shishi Shiguibao has been approved by the FDA
Time of Update: 2021-03-03
BMS announced that the FDA has approved the PD-1 inhibitor Opdivo (nivolumab), in association with the CTLA-4 inhibitor Yeervoy (ipilimumab), to treat patients with hepatocellular carcinoma (HCC) who have previously received treatment with sorapinib.
Sovantini was awarded two fast-track qualifications by the FDA
Time of Update: 2021-03-03
On April 17, He huang China Pharmaceutical Technology Co., Ltd. (Chi-Med, called and Huang Pharmaceuticals) announced that its oral tyrosine kinase inhibitor surufatinib has been awarded two fast-track qualifications by the FDA
New drug for cystic fibrosis (CF)! Vertex triple therapy Trikafta has been given FDA priority review to expand the population (6-11 years old)!
Time of Update: 2021-03-03
therapy Trikafta (elexacaftor/tezacaftor/ivacaftor and the scope of use of cavtor) to include CFTR gene carrying at least one F508del mutation, or CFTR gene carrying a specific mutation and based on in vitro data to respond to Trikafta treatment of 6
Lilly Tauvaid (Flortaucipir F18) is approved by the FDA
Time of Update: 2021-03-03
a way to get this important information in patients. Tauvid in two clinical studies. In study 1, 64 patients with normal and impaired end-stage cognition agreed to undergo Tauvid imaging and participate in the post-mortem
