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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
Natco Pharma receives EIR from US FDA financialexpress
July 21, 2017
The inspection was conducted at Natco Pharma’s Kothur facility in Telangana
FDA approves Vosevi for Hepatitis C worldpharmanews
July 20, 2017
The U.S. Food and Drug Administration has approved Vosevi to treat adults with chronic hepatitis C virus (HCV) genotypes 1-6 without cirrhosis (liver disease) or with mild cirrhosis.
FDA approves new treatment to reduce the risk of breast cancer returning biospectrumasia
July 19, 2017
Nerlynx is the first extended adjuvant therapy, a form of therapy that is taken after an initial treatment to further lower the risk of the cancer coming back.
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

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