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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.
FDA, FTC Warn Companies for Selling Illegal, Unapproved Opioid Cessation Products Using Deceptive Cl americanpharmaceuticalreview
January 25, 2018
The United States Food and Drug Administration (FDA) and the Federal Trade Commission (FTC) sent a joint warning letter to vendors and distributors of 12 opiate smoking cessation products
FDA OKs Topcon’s Ocular Diagnostic Instrument biospace
January 24, 2018
Topcon Medical Systems said today that its DRI OCT Triton Series system won 510(k) clearance from the FDA.
Sobi Receives IND Acceptance from FDA contractpharma
January 24, 2018
Swedish Orphan Biovitrum (Sobi) has announced that the FDA has accepted their investigational new drug (IND) application for the drug candidate SOBI003. In addition, SOBI003 was granted Fast Track status by the FDA.
FDA accepts IND for the treatment of mucopolysaccharidosis type IIIA europeanpharmaceuticalreview
January 24, 2018
The FDA has issued a Study may proceed letter for the first study in humans, thereby accepting the investigational new drug application for the drug candidate SOBI003…
Statement from FDA Commissioner on New Policy Steps for Strengthening Public Warning, Notification o FDA
January 23, 2018
Americans depend on the U.S. Food and Drug Administration (FDA) to help ensure that the products they buy are safe.
FDA Slaps Warning on San Diego's Imprimis Over Eye Drug Advertising biospace
January 18, 2018
The U.S. Food and Drug Administration (FDA) has sent a warning letter to Imprimis Pharmaceuticals, Inc.
FDA approves Lynparza to treat inherited breast cancer pharmaceutical-technology
January 17, 2018
The US Food and Drug Administration (FDA) has approved the use of AstraZeneca’s Lynparza for the treatment of certain types of breast cancer that have metastasized and those with BRCA gene mutation.
FDA report reaffirms safety profile and effectiveness of Bayer's Xarelto® in routine clinical practi worldpharmanews
January 17, 2018
A report from the U.S. Food and Drug Administration (FDA) published in Pharmacoepidemiology & Drug Safety confirms the safety profile and effectiveness of Xarelto® (rivaroxaban) in people with atrial fibrillation (AF).
Varian’s Halcyon got nod from Taiwan, China FDA biospectrumasia
January 17, 2018
Halcyon treatment system requires only nine steps from the start to the end of treatment compared older technologies which required more than 30steps.

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