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FDA approves Vertex’s cystic fibrosis therapy Orkambi for children under six pharmaceutical-technology
August 10, 2018
The US Food and Drug Administration (FDA) has granted approval to Vertex Pharmaceuticals for the use of its Orkambi (lumacaftor/ivacaftor) medicine to treat cystic fibrosis in children between two and five years old.
FDA expands list of valsartan recalls pharmafile
August 10, 2018
The US Food and Drug Administration (FDA) has expanded a list of products containing valsartan that are to be recalled.
FDA Approves Arakoda (tafenoquine) for the Prevention of Malaria drugs
August 10, 2018
60 Degrees Pharmaceuticals (60P) announced today the U.S. Food and Drug Administration (FDA) approval of Arakoda (tafenoquine) tablets for the prevention of malaria in patients aged 18 years and older.
Ampio Pharma craters on FDA setback but plans to fight back fiercebiotech
August 10, 2018
The FDA has asked Ampio Pharma to conduct another clinical trial for its osteoarthritis med, Ampion, setting back its BLA and sending its stock down 79% on Wednesday and another 26% in premarket trading.
FDA finds spiders and insects around packaging of Canadian API maker fiercepharma
August 09, 2018
An FDA inspector didn’t have to spend long to discover that a Canadian API maker was failing to meet FDA standards for product testing, not to mention find insects and spiders in its packaging area.
FDA Approves Poteligeo for Rare Types of Non-Hodgkin Lymphoma drugs
August 09, 2018
Poteligeo (mogamulizumab) injection has been approved by the U.S. Food and Drug Administration to treat adults with two rare types of non-Hodgkin lymphoma.
FDA Approves Poteligeo (mogamulizumab-kpkc) for Mycosis Fungoides and Sézary Syndrome drugs
August 09, 2018
The U.S. Food and Drug Administration today approved Poteligeo (mogamulizumab-kpkc) injection for intravenous use for the treatment of adult patients with relapsed or refractory mycosis fungoides (MF) or Sézary syndrome (SS) after at least one prior syste
Pain Therapeutics refocuses on Alzheimer's after FDA turns down abuse-deterrent opioid painkiller pharmafile
August 08, 2018
The FDA has voted to reject Texas-based Pain Therapeutics’ abuse deterrent opioid painkiller Remoxy (oxycodone), leading the company to consider a strategic restructure and prompting a strong response from its President and CEO.
FDA announces policy shift to encourage new opioid addiction treatments pharmafile
August 08, 2018
The US Food and Drug Administration (FDA) have announced that it is altering the way it evaluates a drug’s ability to treat opioid addiction as part of a move to encourage the development and approval of new opioid addiction treatments.
FDA to support development of nicotine replacement therapies pharmaceutical-technology
August 08, 2018
The US Food and Drug Administration (FDA) has revealed plans to support the development of new nicotine replacement therapies (NRTs) to help eliminate addiction to combustible cigarettes.

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