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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.
NDA of FDA in 2017 Q2: Total Number of New Drugs Approved Having Surpassed That of the 2016 en-cphi.cn
July 07, 2017
With a half of 2017 past, unlike the downturn experienced in 2016, the new drug approval of FDA in 2017 can be called sailing with the wind...
EMA and FDA harmonise over development of Gaucher drugs pharmafile
July 06, 2017
The EMA and the FDA have announced that they have developed a joint proposal to promote more efficient means of bringing through treatments for Gaucher disease.

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