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Zydus Cadila receives US FDA approval for blood pressure drug
August 17, 2017The 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
August 07, 2017The 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
August 04, 2017AstraZeneca’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
August 02, 2017US FDA issued one 483 observation but corrected during the inspections itself -
US FDA concludes inspection of Lupin’s facility without any observations
August 01, 2017The 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
July 18, 2017The 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
July 03, 2017The receipt indicates successful closure of the inspection and queries raised during the audit
Pharma Sources Insight January 2025
