With this validation, the application is complete, and the EMA will now begin the review procedure. Tepotinib is a highly selective oral MET inhibitor that is administered once
In a communication received on November 24, 2020, the FDA reiterated that an inspection of the company’s manufacturing facility is required as part of the BLA approval process.
If successful, this pharmacologic approach could substantially change the treatment paradigm for OSA patients. “There is a clear unmet need for an approach that addresses the underlying cause
The partnership aims to advance HFB30132A, a SARS-CoV-2 neutralizing antibody for the treatment of COVID-19, through clinical development and commercial sale in Russia, pending approval from the Ministry
The FDA has set a Prescription Drug User Fee Act (“PDUFA”) target date of May 21, 2021. “The FDA’s acceptance of our BLA and granting of priority review
“We are encouraged by the European Commission’s and European Medicines Agency’s recognition of the benefit that zanidatamab can provide in the treatment of HER2-expressing gastric cancers as we
“The FDA’s decision supports our ability to provide a new treatment option for critically ill COVID-19 patients with bacterial infections resistant to nearly all other available therapies. This
The trial is enrolling adult epilepsy patients with temporal lobe onset, with or without secondary generalized seizures. A clinical feasibility study at St. Vincent’s Hospital Melbourne (published in The
The study, IMPOWER 22, will evaluate the efficacy and safety of islatravir — Merck’s novel investigational nucleoside reverse transcriptase translocation inhibitor (NRTTI) under evaluation for both treatment and
Dr. Himanshu Pop Hale, Ace Hospital Pune, India, has recruited the first patient in the IPF phase II Proof-of-Concept study with C21 (VP01 project). “We are pleased to announce that
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