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FDA asks for additional data to approve Evenity in US pharmaceutical-technology
July 19, 2017
Pharmaceutical companies Amgen and UCB have received a Complete Response Letter from the US Food and Drug Administration (FDA) for Evenity, a treatment for postmenopausal women with osteoporosis.
Impax Announces FDA Approval of AB Rated Generic Concerta Extended-Release Tablets CII americanpharmaceuticalreview
July 18, 2017
Impax announced it has received an AB therapeutic equivalent rating and final U.S. Food and Drug Administration (FDA) approval on its Abbreviated New Drug Application for a generic version of Concerta (methylphenidate hydrochloride) Extended-Release table
FDA recommends approval for Novartis’ CTL019 to treat r/r B-cell ALL pharmaceutical-technology
July 17, 2017
The US Food and Drug Administration’s (FDA) Oncologic Drugs Advisory Committee (ODAC) has unanimously recommended approval of Novartis’ CTL019 (tisagenlecleucel) for the treatment of relapsed or refractory (r/r) B-cell acute lymphoblastic leukaemia (ALL).
US FDA issues warning letter to Hyderabad-based Vista Pharma financialexpress
July 14, 2017
The warning letter summarises significant violations of CGMP regulations
Novartis CAR-T safety in FDA spotlight pharmaphorum
July 12, 2017
FDA advisers are set to make recommendations on Novartis’ groundbreaking CAR-T therapy CTL019 tomorrow – and are set to focus on safety concerns in the decisive meeting.
FDA Approves Endari for Sickle Cell Disease americanpharmaceuticalreview
July 11, 2017
Emmaus Life Sciences announced the U.S. Food and Drug Administration (FDA) approved Endari (L-glutamine oral powder) to reduce the severe complications of sickle cell disease (SCD) in adult and pediatric patients age 5 and older.
Endo gives way and withdraws opioid painkiller after FDA pressure pharmaphorum
July 11, 2017
Endo Pharmaceuticals has announced it will remove its Opana ER opioid painkiller from the US market, a month after the FDA requested because of the potential for abuse.
FDA Grants Orphan Drug Designation for Investigational WT1 Cancer Peptide Vaccine DSP-7888 americanpharmaceuticalreview
July 11, 2017
Boston Biomedical announced the U.S. Food and Drug Administration (FDA) has granted Orphan Drug Designation (ODD) for DSP-7888, an investigational cancer peptide vaccine, for the treatment of myelodysplastic syndrome (MDS).
FDA approves Bristol-Myers Squibb’s Orencia for active psoriatic arthritis pharmaceutical-technology
July 11, 2017
The US Food and Drug Administration (FDA) has approved Bristol-Myers Squibb’s Orencia for the treatment of adult patients with active psoriatic arthritis (PsA).
Novartis combination targeted therapy receives FDA approval europeanpharmaceuticalreview
July 10, 2017
The FDA has approved Novartis’ Tafinlar (dabrafenib) in combination with Mekinist (trametinib) to treat patients with metastatic non-small cell lung cancer.

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