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FDA Approves Lucemyra drugs
May 17, 2018
The U.S. Food and Drug Administration today approved Lucemyra (lofexidine hydrochloride) for the mitigation of withdrawal symptoms to facilitate abrupt discontinuation of opioids in adults.
FDA places PaxVax's phase 2 chikungunya shot on its fast track fiercevaccines
May 17, 2018
Working against a disease with no available vaccines, PaxVax has picked up an important regulatory boost from the FDA for its chikungunya shot.
FDA approves Briviact for partial-onset seizures in paediatric epilepsy europeanpharmaceuticalreview
May 16, 2018
The approval provides paediatric epilepsy patients a treatment option which can be initiated at a therapeutic dose from day one…
In split vote, FDA advisory committee backs Akcea/Ionis’ volanesorsen fiercebiotech
May 16, 2018
An FDA advisory committee voted 12-8 on Thursday to recommend the approval of Akcea Therapeutics’ volanesorsen, an RNAi drug for rare lipid disorder familial chylomicronemia syndrome.
FDA grants fast track designation for a Chikungunya vaccine europeanpharmaceuticalreview
May 15, 2018
Fast Track program is designed to facilitate development and expedite review of therapies and vaccines to address unmet health needs…
FDA approves Novartis’ Gilenya for paediatric use pharmatimes
May 15, 2018
US regulators have approved Novartis’ Gilenya to treat children and adolescents with relapsing forms of multiple sclerosis (RMS), making it the first disease-modifying therapy indicated for this patient group.
FDA rejects Perrigo knockoff of Teva's ProAir inhaler for third time fiercepharm
May 15, 2018
In a new twist on the good news/bad news paradigm, the FDA has informed Perrigo to expect a complete response letter for its copy of Teva’s popular ProAir inhaler.
FDA launches lawsuits against stem cell clinics after patients rendered blind pharmafile
May 15, 2018
At the request of the FDA, The US Department of Justice has launched legal action seeking to shut down stem cell clinics in California and Florida for allegedly peddling scientifically-unproven treatments which have left some patients blind.
FDA awards first paediatric MS approval to Novartis' Gilenya pharmafile
May 15, 2018
The FDA has awarded approval for what it says is its first drug for the treatment of multiple sclerosis (MS) in paediatric patients, giving the green light to Novartis’ Gilenya (fingolimod) specifically in relapsing forms of the disease following its desi
FDA approves Tafinlar-Mekinist combination for the treatment of ATC europeanpharmaceuticalreview
May 11, 2018
The U.S. Food and Drug Administration has approved Tafinlar and Mekinist administered together, for the treatment of anaplastic thyroid cancer that cannot be removed by surgery…

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