We need to ‘operationalize’ COVID testing: Co-Diagnostics CEO Co-Diagnostics CEO Dwight Egan gives details on his company’s new rapid at-home COVID test. The FDA announced this week that the recall
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FDA Panel Convenes To Discuss Requirement Of Moderna Vaccine Booster Shots
The U.S Food and Drug Administration panel is holding an important meeting on Thursday to discuss and vote on whether permission should be given for the use of booster shots
Continue reading »FDA authorizes first e-cigarette, cites benefit for smokers
FDA advisory committee reviewing Pfizer vaccine data for ages 5-11 ‘extremely important’: Dr. Siegel Pfizer asked for FDA approval of its COVID vaccine for children ages 5 to 11. The
Continue reading »Biotech Stocks Facing FDA Decision In October 2021
As we head into the fourth quarter of 2021, here is a recap of what happened on the regulatory front this month that caught our attention. Samsung Bioepis’ Byooviz became
Continue reading »Pfizer Further Expands Recall Of Anti-smoking Drug Chantix
Drug major Pfizer has again expanded the earlier two recalls of its anti-smoking Drug Chantix (Varenicline) in the form of tablets, to now include all the lots, for the potential
Continue reading »Biogen’s Aduhelm Gets FDA Approval – A New Drug For Alzheimer’s In 18 Years, Priced At $56,000/Yr
A new treatment for Alzheimer’s in 18 years has made it to the finish line, thanks to the FDA approval of Aduhelm. Aduhelm, developed by Biogen Inc.(BIIB)/Eisai Co., Ltd., has
Continue reading »Pfizer COVID-19 Vaccine Allowed To Store In Refrigerator For A Month : FDA
The U.S. Food and Drug Administration has authorized unopened, thawed Pfizer-BioNTech COVID-19 vaccine vials to be stored in a refrigerator at 2 to 8 degrees Celsius for up to one
Continue reading »AstraZeneca’s Farxiga Approved In U.S. For Chronic Kidney Disease
British drug major AstraZeneca’s Farxiga (dapagliflozin) oral tablets can now be used in the United States to treat chronic kidney disease regardless of diabetes status. The U.S. Food and Drug
Continue reading »FDA asks Emergent plant to pause manufacturing while it investigates botched Covid vaccines
The FDA asked Emergent BioSolutions to temporarily stop producing materials for Covid-19 vaccines while U.S. regulators investigate its plant in Baltimore responsible for ruining millions of J&J, Emergent said in
Continue reading »First FDA-approved Immunotherapy For First Treatment Of Gastric Cancer
The U.S. Food and Drug Administration has approved Bristol-Myers Squibb Co.’s Opdivo (nivolumab), in combination with certain types of chemotherapy, to become the first immunotherapy for the initial treatment of
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