Health
CSOFT’s health blog aims to provide insight into complex diseases, treatment options and regulatory developments, and other prevalent health issues people face today.
FDA Approves First Prostate Cancer Hormone Treatment
Today (12/21) the U.S. Food and Drug Administration (FDA) approved the first oral treatment for prostate cancer, a disease that affects on average one in every nine men. Orgovyx, created by Myovant, was created to treat advanced prostate cancer cases by blocking the...
Moderna COVID-19 Vaccine Receives FDA Emergency Use Authorization
On Friday (12/18) The U.S Food and Drug Administration granted Moderna Emergency Use Authorization for their COVID-19 vaccine in adults over 18 years old. In addition to Pfizer’s vaccine, the U.S government agreed to purchase 200 million doses from Moderna which will...
GlaxoSmithKline, MacroGenics Inc. and More Receive FDA Approvals
The U.S. Food and Drug Administration (FDA) had many approvals this week including a treatment created by GlaxSmithKline for Lupus Nephritis in adults, one of the most common autoimmune diseases. The FDA approval for GlaxoSmithKline was historic, as Benlysta is the...
Jet 7 Xtra Flex Catheter for Stroke Patients Recalled by Penumbra
Following the close of the market on Tuesday, Penumbra announced the U.S. Food and Drug Administration (FDA) advised recall of their catheter device resulting from 14 reported patient deaths, among other patient hemorrhages,...
Emergency Use Authorization Given to Ellume’s At-Home COVID-19 Test
On December 15, 2020, the U.S. Food and Drug Administration (FDA) approved the first over the counter fully at-home COVID-19 Test. The test delivers results in approximately 20 minutes and diagnoses individuals as young as two years old and is expected to be delivered...
Pre-Market Review Option Rolled Out by FDA for 510k Clearance
Under its Abbreviated 510k Program, the U.S. Food and Drug Administration (FDA) outlined guidelines for the Safety and Performance Based Pathway, a fast track for medical devices in well established categories to gain market...
Pfizer and BioNTech Receive Premier COVID-19 Vaccine Authorization
Pfizer and BioNTech have made history with their COVID-19 vaccine, as it is the first to enter the U.S. market after Phase 3 clinical trial results showing 95% efficacy. The mRNA vaccine is being allocated for emergency use to hospitals nationwide,...
AstraZeneca Partners with Sputnik to Boost COVID-19 Vaccine Efficacy
Russia’s Sovereign Health Plan disclosed today (12/11) that Sputnik-V will be joining AstraZeneca in their pursuit for a COVID-19 vaccine. The joint vaccine production will enter clinical trial phases on adults 18 years and older by the...
The European Medicines Agency (EMA) Suffers Cyber Attack
BioNTech released a statement on December 9, 2020 that Pfizer and their COVID-19 vaccine documents was “unlawfully accessed” in a breach on the European Medical Agency's (EMA) system. The severity of the attack was not divulged, however the EMA disclosed that they...
FDA Breakthrough Designation Given to ReGelTec
ReGelTec, a medical device company out of Baltimore’s leading medical device HYDRAFIL, has received Breakthrough Designation from the U.S. Food and Drug Administration (FDA). The Breakthrough Device Program was created with intentions to expedite the...
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