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New 483 Observations Unlikely to Impact Much Awaited Revance's Daxi Approval, Says This Analyst
Benzinga via Yahoo Finance· 2 years agoRevance Therapeutics Inc (NASDAQ: RVNC) delivered a solid Q2 of RHA filler sales of $25.5 million,...
FDA flags issues at Coherus partner's China plant for cancer drug
Reuters via Yahoo News· 1 year agoHowever, the company said those observations, raised in Form 483, were "easily addressable", adding...
U.S. FDA found lapses at Novo's main U.S. factory in May 2022 -report
Reuters via Yahoo News· 9 months agoLONDON (Reuters) -U.S. drug regulators issued a report detailing quality control lapses at Novo...
Exclusive-US FDA finds control lapses at Moderna manufacturing plant
Reuters via Yahoo News· 6 months agoU.S. drug regulators in September found quality control lapses at Moderna’s main factory including...
Coherus (CHRS) Gets CRL for Udenyca Onbody, Shares Down
Zacks via Yahoo Finance· 9 months agoShares of commercial-stage biopharmaceutical company Coherus BioSciences, Inc. CHRS were down 9.2%...
FDA finds no misconduct at trial sites for Pfizer's Lyme disease shot- Care Access
Reuters via Yahoo News· 8 months agoPfizer and Valneva said in February they will stop testing the vaccine in roughly half of U.S....
FDA letter requests compliance proof after Big Olaf Creamery listeria outbreak
Herald-Tribune via Yahoo News· 1 year agoBig Olaf Creamery manufactures have not yet responded to a letter from the FDA asking for proof of...
Novo Nordisk shares fall after media report about quality lapses at US plant
Reuters via Yahoo Finance· 9 months agoNovo Nordisk's shares fell on Monday after financial news agency MarketWire reported that U.S. drug...
Alvotech (ALVO) Up on BLA Update for Two Biosimilar Candidates
Zacks via Yahoo Finance· 5 months agoThe FDA concludes the reinspection of Alvotech's (ALVO) facility in Iceland. The company believes...
Contaminated Drugs, Shredded Papers: US FDA Uncovers Failures in India Pharma Factories
Bloomberg via Yahoo News· 1 year ago(Bloomberg) -- US inspectors have in recent months uncovered wide-ranging lapses at factories run by...