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Lupin receives EIR from USFDA for Pithampur facility biospectrumasia
April 08, 2018
The inspection was conducted in July 2017
Summary of Warning Letters Issued by FDA in 2018 Q1 zhulikou431
April 08, 2018
FDA issued 17 warning letters on production quality (including 6 in January, 7 in February, and 4 in March) in 2018 Q1
Analysis of Warning Letters Issued by FDA in 2018 Q1 zhulikou431
April 08, 2018
Situation of Strict Regulation of Pharmaceutical Agencies Stays Unchanged
FDA Issues CLRs for Two Celltrion and Teva Biosimilars biospace
April 08, 2018
The U.S. Food and Drug Administration (FDA) issued two Complete Response Letters (CRLs) to South Korean manufacturer Celltrion.
FDA committee votes to approve lofexidine for opioid withdrawal pharmaceutical-technology
April 03, 2018
The US Food and Drug Administration (FDA) Psychopharmacologic Drugs Advisory Committee has voted to approve lofexidine hydrochloride to treat symptoms of opioid withdrawal.
FDA expands approval of Blincyto for treatment of a type of leukemia in patients who have a certain risk factor for relapse biospace
March 30, 2018
FDA granted accelerated approval to Blincyto (blinatumomab) to treat adults and children with B-cell precursor acute lymphoblastic leukemia (ALL) who are in remission but still have minimal residual disease (MRD)
Scholar Rock Granted Orphan Drug Designation by the FDA for SRK-015 for the Treatment of Patients with Spinal Muscular Atrophy biospace
March 30, 2018
Announced today that the U.S. Food and Drug Administration (FDA) has awarded its orphan drug label (ODD)
FDA Gives Mylan’s New HIV Drug a Thumbs-Up biospace
March 29, 2018
The U.S. Food and Drug Administration (FDA) approved Mylan NV’s Symfi (efavirnenz, lamivudine and tenofovir disoproxil fumarate) for adult and pediatric HIV-1 patients who weigh at least 40 kilograms.
FDA Approves New Innovations on Hologic's 3Dimensions™ Mammography System, the Fastest, Highest Resolution Breast Tomosynthesis System Ever(1) biospace
March 28, 2018
Hologic, Inc.announced today that Clarity HD high-resolution 3D™ imaging and Intelligent 2D™ imaging technology have received PMA approval from the FDA and are now available on the 3Dimensions breast tomosynthesis system
FDA approves Toujeo® Max SoloStar® biospace
March 28, 2018
The U.S. Food and Drug Administration (FDA) approved Sanofi's Toujeo® (insulin glargine 300 Units/mL) Max SoloStar®, the highest capacity long-acting insulin pen that will be available on the market.

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