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Resverlogix Receives Approval Pathway from the FDA as to the Inclusion of USA Patients in the Phase en-cphi.cn
July 26, 2017
"BETonMACE Phase 3 Trial with apabetalone to expand to include the United States"
FDA Expands Approval of Yervoy (ipilimumab) to Include Pediatric Patients 12 Years and Older with Un drugs.com
July 26, 2017
Bristol-Myers Squibb Company (NYSE:BMY) announced that FDA has expanded the indication for Yervoy (ipilimumab) injection for intravenous use to now include the treatment of unresectable or metastatic melanoma in pediatric patients 12 years of age and olde
FDA Chief plans regulatory overhaul to tackle US opioid crisis pharmafile
July 26, 2017
The US faces an ongoing crisis in opioid dependency, and FDA Commissioner Scott Gottlieb is prepared to employ unusual tactics to tackle the problem
FDA Expands Approval of Yervoy americanpharmaceuticalreview
July 25, 2017
Bristol-Myers Squibb announced the U.S. Food and Drug Administration (FDA) has expanded the indication for Yervoy (ipilimumab) injection for intravenous use to now include the treatment of unresectable or metastatic melanoma...
U.S. Food and Drug Administration expands approval of Yervoy® (ipilimumab) to include pediatric pati worldpharmanews
July 25, 2017
Bristol-Myers Squibb Company today announced that the U.S. Food and Drug Administration has expanded the indication for Yervoy ) injection for intravenous ,,,
FDA unveils plan to eliminate orphan designation backlog FDA
July 25, 2017
The U.S. Food and Drug Administration unveiled a strategic plan to eliminate the agency’s existing orphan designation request backlog and ensure continued timely response to all new requests for designation with firm deadlines.
GSK receives FDA approval for a new self-injectable formulation of Benlysta cphi-online
July 25, 2017
The approval marks the first subcutaneous self-injection treatment option for patients with systemic lupus erythematosus.
FDA clears first neonatal magnetic resonance imaging device europeanpharmaceuticalreview
July 24, 2017
Today, the U.S. Food and Drug Administration cleared the first magnetic resonance imaging (MRI) device specifically for neonatal brain and head imaging in neonatal intensive care units (NICU)…
Novartis CTL-019 unanimously passed by FDA: last mile for the marketing of the worlds’ first CAR-T en-cphi.cn
July 21, 2017
Novartis’ CAR-T therapy Tisagenlecleucel (CTL-019) evaluated by FDA is undoubtedly an important moment as there is only the final mile for the marketing of the world’s first CAR-T.
Despite scoring an FDA nod, Merck's biosim Lusduna must wait to challenge Lantus fiercepharma
July 21, 2017
Sanofi’s top-selling Lantus is already contending with one copycat rival, and Merck & Co. just won FDA approval for another. Luckily for the $5 billion basal insulin, Merck’s new Lusduna Nexvue has to sit on the sidelines for now—and maybe for more than a

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