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FDA Approves EYLEA Injection Prefilled Syringe americanpharmaceuticalreview
August 14, 2019
Regeneron Pharmaceuticals announced the U.S. Food and Drug Administration (FDA) has approved the Chemistry, Manufacturing and Controls (CMC) Prior-Approval Supplement (PAS) for the EYLEA® (aflibercept) Injection prefilled syringe.
'Miracle Mineral Solution' Is No Miracle Cure, FDA Warns drugs
August 14, 2019
Miracle Mineral Solution, which is sold online as a medical treatment, can cause serious and potentially life-threatening health problems and should not be bought or used by consumers...
Unichem Laboratories gets US FDA nod for hypertension management expresspharma
August 13, 2019
Drug firm Unichem Laboratories has received approval from the US health regulator to market Chlorthalidone tablets, used to treat high blood pressure.
US FDA issues six observations to Natco Pharma’s API facility near Hyderabad expresspharma
August 13, 2019
Natco Pharma announced that the US health regulator has made six observations after the completion of inspection of active pharmaceutical ingredient (API) facility in Mekaguda Village, near Hyderabad.
FDA grants Orphan Drug Designation to DYN101 treatment europeanpharmaceuticalreview
August 13, 2019
A treatment for Centronuclear Myopathies has received Orphan Drug Designation from the FDA and will begin Phase I/II trials.
US FDA completes audit of Dr Reddy’s Louisiana-based facility expresspharma
August 12, 2019
Dr Reddy’s Laboratories announced the US health regulator has completed audit of its Louisiana-based formulations manufacturing facility, following which no form 483 was issued.
Kala Receives CRL from FDA for KPI-121 0.25% NDA for Dry Eye Disease americanpharmaceuticalreview
August 12, 2019
Kala Pharmaceuticals has received a complete response letter (CRL) from the U.S. Food and Drug Administration (FDA) regarding the Company’s new drug application (NDA) for KPI-121 0.25% for the temporary relief of the signs and symptoms of dry eye disease.
FDA antibody biosimilar product approvals increase in 2019 europeanpharmaceuticalreview
August 12, 2019
2019 has seen a marked increase of antibody biosimilar product approvals in the first half of the year, according to a report.
With importation on tap, Grassley urges FDA to inspect foreign drug plants 'unannounced' fiercepharma
August 11, 2019
Sen. Chuck Grassley is all for importing drugs to drive down prices. He just wants the Trump administration to stop warning foreign manufacturing plants that FDA inspectors are on their way—particularly in India and China.
Blueprint Medicines Announces FDA Acceptance of NDA for Avapritinib americanpharmaceuticalreview
August 09, 2019
Blueprint Medicines announced the U.S. Food and Drug Administration (FDA) has accepted the company's New Drug Application (NDA) for avapritinib for the treatment of adult patients with ...

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