Angry FDA & CDC: $5 Billion Bivalent Moderna New Crown Vaccine Not As Effective As Monovalent
Was the omission of key data intentional or unintentional?
Apparatus
Medical
Good News, Orphan Drug Status Granted By The FDA For Ezurpimtrostat, a Cutting Edge Drug For Liver Cancer!
The FDA has recently granted orphan drug designation to Ezurpimtrostat, a PPT-1 inhibitor for the treatment of patients with hepatocellular carcinoma (HCC).
Apparatus
Fda Accepts Zuranolone's Nda Application And Grants It Priority Review For The Treatment Of Mdd And Pdd
Approval for new FIC depression drug on the horizon!
Apparatus
Inventory Of Fda-Approved Adc Drugs
The global ADC drug market will be approximately $5.2 billion by 2021
Medical
New Treatment For Uroepithelial Carcinoma Receives Fda Fast Track Designation With Encouraging Initial Results
The FDA granted Fast Track designation to a new drug, IK-175, in combination with nabumab for the treatment of advanced uroepithelial carcinoma, after preliminary trial data showed encouraging and durable anti-tumor activity with a favorable safety profile.
Apparatus
FDA Approves Vabysmo, The First Bispecific Antibody For The Eye!
The US Food and Drug Administration has approved Vabysmo (faricimab-svoa), for the treatment of wet age-related macular degeneration (AMD) and diabetic macular oedema (DME).
Apparatus
New Drug Expected For Patients With Low HER2 Expression, FDA Grants Priority Review Status To Enhertu
The FDA granted priority review status to Enhertu (DS-8201) for the treatment of patients with HR-positive, low HER2-expressing breast cancer, and Enhertu has enabled these patients to remain disease-free for an average of 10.1 months, with an average overall survival time of nearly two years. A decision on approval is expected to be made in the fourth quarter of this year.
Apparatus
Newly Approved Targeted Drug Makes 79% Of Patients' Tumours Disappear Altogether, This Type Of Blood Tumour Is Saved!
The US FDA has approved pemigatinib, the first targeted drug to date for patients with specific mutated blood tumours, and the results of the study show that the drug made tumours disappear completely in 79% of patients!
Apparatus
Another Cancer-Independent Targeted Drug Approved! Up To 84% Efficacy!
Targeted drug Selpercatinib has received accelerated approval from the FDA. It is cancer-independent and may benefit any solid tumour with a positive RET gene fusion. It is up to 84% effective in selected patients with non-small cell lung cancer!
Apparatus
FDA Grants Orphan Drug Status To Two New Therapies In a Row, And These Two Groups Of Patients Are Expected To Benefit!
Recently, the US FDA has granted orphan drug status to two new therapeutics in a row. One is a small molecule inhibitor, PCLX-001, for the treatment of acute myeloid leukaemia; the other is a T-cell therapy, ET140203, for the treatment of hepatoblastoma. Both therapies are currently in relevant trials.