CytoDyn reaches historical milestone, submits first of three sections of BLA to FDA for leronlimab (PRO 140) as a combination therapy for HIV

18 March 2019 - FDA previously granted rolling review for BLA. ...

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Janssen submits application to U.S. FDA seeking approval of Darzalex (daratumumab) combination therapy for patients with newly diagnosed multiple myeloma who are transplant ineligible

12 March 2019 - Application supported by the Phase 3 MAIA study being reviewed under the FDA Real-Time Oncology Review pilot ...

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Esperion announces submissions of two NDAs and official completion of two MAA validations for both bempedoic acid and the bempedoic acid/ezetimibe combination tablet

28 February 2019 - Esperion today announced that the company has successfully completed important and key global marketing applications including ...

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FDA grants fast track designation for AMG 420

3 December 2018 - Amgen today announced the first clinical results from studies evaluating investigational novel bi-specific T cell engager (BiTE) ...

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AbbVie announces Imbruvica (ibrutinib) plus rituximab approval by U.S. FDA as first chemotherapy-free combination treatment in adults with Waldenström's macroglobulinemia, a rare type of blood cancer

27 August 2018 - Milestone represents ninth FDA approval for Imbruvica in less than five years since its initial approval. ...

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FDA expedites review of Novartis drug Promacta for first-line severe aplastic anaemia

30 May 2018 - Regulatory action underscores the treatment potential of Promacta for a rare and serious blood condition. ...

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Stemline Therapeutics announces start of rolling BLA submission for SL-401

5 April 2018 - Stemline Therapeutics announced today that it has initiated its rolling submission of a biologics license application for ...

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Mylan introduces Symfi triple combo once-daily HIV treatment in the U.S.

28 March 2018 - All ARV regimens are being offered at a significant discount to the price of competing products to ...

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Verastem submits new drug application to U.S. FDA for duvelisib for the treatment of patients with relapsed or refractory chronic lymphocytic leukaemia leukaemia/small lymphocytic lymphoma and follicular lymphoma

7 February 2018 - Verastem today announced it has submitted a new drug application to the U.S. FDA seeking full approval ...

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Braeburn receives complete response letter for CAM2038 injectable buprenorphine depot for the treatment of opioid use disorder

21 January 2018 - Braeburn Pharmaceuticals today announced that it has received a complete response letter from the U.S. FDA regarding ...

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Mesoblast receives FDA regenerative medicine advanced therapy designation for its cell therapy in heart failure patients with left ventricular assist devices

21 December 2017 - Mesoblast today announced that the United States FDA has granted Regenerative Medicine Advanced Therapy (RMAT) designation for ...

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Pfizer announces FDA approval of Xeljanz (tofacitinib) and Xeljanz XR for the treatment of active psoriatic arthritis

14 December 2017 - Xeljanz/Xeljanz XR, the first oral JAK inhibitor in the U.S.for adults with moderate to severe rheumatoid arthritis, ...

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FDA approves Genentech’s Alecensa (alectinib) as first-line treatment for people with specific type of lung cancer

6 November 2017 - Approval based on Phase III results that showed Alecensa extended the average time that people lived without ...

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Novartis submits application to FDA for Kymriah (tisagenlecleucel) in adult patients with r/r DLBCL, seeking second indication for first-ever FDA approved CAR-T therapy

31 October 2017 - Submission based on updated analyses from global, multi-centre Phase II JULIET study, which met primary endpoint, including ...

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FDA approves CAR-T cell therapy to treat adults with certain types of large B-cell lymphoma

18 October 2017 - The U.S. FDA today approved Yescarta (axicabtagene ciloleucel), a cell-based gene therapy, to treat adult patients with ...

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