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Zydus Cadila receives US FDA approval for blood pressure drug expressbpd
August 17, 2017
The drug will be manufactured at the groups formulations manufacturing facility at pharma SEZ in Ahmedabad
US FDA approves AbbVie's imbruvica for treatment of adults with cGVHD pharmaceutical-technology
August 07, 2017
The US Food and Drug Administration (FDA) has expanded the approval of imbruvica (ibrutinib) for the treatment of adult patients with chronic graft-versus-host-disease (cGVHD) after the failure of one or more treatments.
US FDA grants breakthrough therapy designation for AstraZeneca’s MCL treatment pharmaceutical-technology
August 04, 2017
AstraZeneca’s acalabrutinib has received breakthrough therapy designation from the US Food and Drug Administration (FDA) for the treatment of patients...
US FDA concludes Lupin’s Aurangabad facility inspection expressbpd
August 02, 2017
US FDA issued one 483 observation but corrected during the inspections itself
US FDA concludes inspection of Lupin’s facility without any observations expressbpd
August 01, 2017
The company successful completes PAI and GMP inspection of its Pithampur manufacturing facility – Unit 1
US FDA accepts Pfizer’s sNDA for Xeljanz to treat ulcerative colitis pharmaceutical-technology
July 18, 2017
The US Food and Drug Administration (FDA) has accepted for filing Pfizer’s supplemental New Drug Application (sNDA) for Xeljanz (tofacitinib citrate), an investigational oral solution to treat adult patients affected with moderately to severely active ulc
Unichem gets EIR from US FDA for Goa plant expressbpd
July 03, 2017
The receipt indicates successful closure of the inspection and queries raised during the audit

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