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FDA approval

This page shows the latest FDA approval news and features for those working in and with pharma, biotech and healthcare.

Novartis makes case for gene therapy Zolgensma in SMA

Novartis makes case for gene therapy Zolgensma in SMA

New data revealed ahead of FDA review. Novartis has released some new phase 3 data from its recently-acquired gene therapy Zolgensma, and the results build on the drug’s already ... If the drug gets approval from the FDA, which analysts have tipped as

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  • Amgen and UCB’s Evenity finally approved, but with label warnings Amgen and UCB’s Evenity finally approved, but with label warnings

    Additional data from the FRAME trial helped change the FDA’s mind at the second time of asking, securing what is a major new product approval for Amgen and UCB. ... Amgen’s R&D head David Reese welcomed the FDA approval, and said postmenopausal

  • Pfizer gets EU nod for Tagrisso rival Vizimpro Pfizer gets EU nod for Tagrisso rival Vizimpro

    Now, with approval on both sides of the Atlantic, the drug can mount a stronger challenge against Tagrisso (osimertinib), Iressa, and other EGFR-targeted drugs including Roche/Astellas’ first-generation drug ... Last November, the drugmaker claimed FDA

  • Tecentriq combo shows promise in triple negative breast cancer Tecentriq combo shows promise in triple negative breast cancer

    Tumours reduced in 73% of trial participants. Fresh from having gained the first checkpoint inhibitor approval in triple negative breast cancer (TNBC) with Tecentriq, Roche has presented phase 1b data of ... Roche. Tecentriq's FDA approval in triple

  • Gilead and Galapagos close in on filing for Xeljanz rival Gilead and Galapagos close in on filing for Xeljanz rival

    already been submitted for approval with a verdict expected in the third quarter. ... In both studies there was a low incidence of venous thrombosis, a side effect that held up the approval of Olumiant by the FDA and resulted eventually in a green light

  • Sage’s postpartum depression treatment Zulresso gains US approval Sage’s postpartum depression treatment Zulresso gains US approval

    First approval of its kind. The FDA has approved Sage Therapeutics’ treatment for postpartum depression, Zulresso (brexanolone). ... The FDA approval of Zulresso is based on clinical trials in women with moderate and severe PPD, aged between 18 and 45

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  • Immuno-oncology in 2019: the rapid evolution continues Immuno-oncology in 2019: the rapid evolution continues

    Frontline monotherapy in NSCLC. The next regulatory milestone for Keytruda will be FDA approval as a first-line monotherapy in locally advanced or metastatic non-squamous or squamous non-small cell ... The FDA had been expected to grant approval in

  • Drug launches to watch in 2019 Drug launches to watch in 2019

    Vitrakvi(larotrectinib) gained FDA approval in late November to treat any solid tumours that have a neurotrophic tyrosine receptor kinase (NTRK) gene fusion, which causes the production of TRK, a family ... The product gained EMA approval in November and

  • AstraZeneca’s oncology renaissance AstraZeneca’s oncology renaissance

    from clinical trials to FDA approval in just over two years. ... On one hand, it has scored a major success this year by gaining US and EU approval as a monotherapy maintenance treatment for NSCLC patients with inoperable stage 3 disease, ie

  • Deal Watch October 2018

    The termination comes as a consequence of patent infringement litigation which has placed a stay on the FDA’s approval of the biosimilar, Lusduna Nexvue, in the US.

  • Alnylam’s big moment: bringing groundbreaking RNAi drugs to Europe Alnylam’s big moment: bringing groundbreaking RNAi drugs to Europe

    platform. Led by founder and CEO John Maraganore, Alynlam finally crossed the line in August when it gained FDA and EU approval for its first drug, Onpattro. ... disease which is seen as key for patients’ long term survival, and is already under review

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