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
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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
Continue reading »AstraZeneca, FibroGen: FDA To Convene Committee Meeting To Review Roxadustat In Anaemia Of CKD
AstraZeneca Plc. (AZN.L,AZN) announced Tuesday that the US Food and Drug Administration or FDA informed FibroGen, Inc. that it will convene a meeting of the Cardiovascular and Renal Drugs Advisory
Continue reading »FDA Says No To ATNX And CRMD, Morphic Jumps On IBD Trial Data, INO’s REVEAL 1 Meets Goals
Today’s Daily Dose brings you news about the regulatory set back of Athenex’s oral Paclitaxel and CorMedix’s Defencath, ASLAN Pharma’s Atopic Dermatitis trial results, FDA panel review of FibroGen’s Roxadustat,
Continue reading »NDAL MFG Recalls Manukaguard Allercleanse Nasal Spray
NDAL MFG Inc. called back one lot of Manukaguard Allercleanse nasal spray citing yeast contamination, the U.S. Food and Drug Administration said in a statement. The spray is used to
Continue reading »Nine Firms Issued Warning Letters Against Selling Unauthorized E-liquids
The U.S. Food and Drug Administration (FDA) has issued warning letters to nine firms who manufacture and operate websites selling electronic nicotine delivery system (ENDS) products, specifically e-liquids. The move
Continue reading »Novavax Does It Again!
Shares of Novavax Inc. (NVAX) set a fresh record high of $235.50 on Friday as investors cheered the company’s coronavirus vaccine trial results. The company’s protein-based COVID-19 vaccine candidate, NVX-CoV2373,
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