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Upsher-Smith Receives FDA Approval for Bumetanide Tablets, USP biospace
January 31, 2018
Upsher-Smith today announced that it has received U.S. Food and Drug Administration (FDA) approval of its abbreviated new drug application (ANDA) for Bumetanide Tablets, USP, 0.5 mg, 1 mg, and 2 mg.
Strides Shasun receives US FDA approval expressbpd
January 30, 2018
The company received the approval for Tenofovir Disoproxil Fumarate Tablets, 300 mg from the United States Food & Drug Administration
FDA revises methods, after public outrage at testing of monkeys pharmafile
January 30, 2018
The story broke in September of last year that the FDA was testing nicotine addiction in squirrel monkeys and that four had died as a result of their treatment at the hands of the agency.
FDA approves Lutathera for somatostatin receptor-positive GEP-NETs europeanpharmaceuticalreview
January 30, 2018
The FDA has approved Lutathera for the treatment of a type of cancer that affects the pancreas the gastrointestinal tract…
FDA Formally Rejects Aradigm's Linhaliq, Requests a New Phase III Trial for Reconsideration biospace
January 30, 2018
Aradigm Corporation today announces that it received a CRL from FDA regarding its NDAfor Linhaliq™ as a treatment for non-cystic fibrosis bronchiectasis (NCFBE) patients with chronic lung infections with Pseudomonas aeruginosa
FDA Calls Roche's Autism Drug a Breakthrough biospace
January 30, 2018
An experimental Roche drug designed to improve social interaction in people with autism scored the U.S. Food and Drug Administration’s Breakthrough Therapy Designation.
iQOS heat-not-burn electronic tobacco product doesn't reduce health risk, FDA says pharmafile
January 29, 2018
An advisory panel of the FDA has judged that US tobacco firm PMI has not been able to prove that its new iQOS electronic tobacco device can reduce the risk of smoking-related diseases, and thus should not be able to make such a claim.
FDA approves new treatment for certain digestive tract cancers worldpharmanews
January 29, 2018
The U.S. Food and Drug Administration today approved Lutathera (lutetium Lu 177 dotatate) for the treatment of a type of cancer that affects the pancreas or gastrointestinal tract called gastroenteropancreatic neuroendocrine tumors (GEP-NETs).
Novartis' Bet Pays Off as Advanced Accelerator Applications Wins FDA Nod for Lutathera biospace
January 29, 2018
Advanced Accelerator Applications, a leader in Novartis and nuclear medicine, announced today that it has received FDA approval for its new drug application
FDA Approves Shire Manufacturing Move contractpharma
January 25, 2018
The U.S. Food and Drug Administration has granted approval for the technology transfer of Shire’s CINRYZE (C1 esterase inhibitor [human]) drug product manufacturing process to its Vienna, Austria manufacturing site.

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