Genmab announces European regulatory submission for daratumumab in combination with lenalidomide and dexamethasone in frontline multiple myeloma

22 March 2019 - Type II variation application submitted to the EMA for daratumumab in combination with lenalidomide and dexamethasone as ...

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Novo Nordisk files oral semaglutide for US regulatory approval of glycaemic control, as well as for CV risk reduction for oral semaglutide and Ozempic

20 March 2019 - Novo Nordisk today announced the submission of two new drug applications to the US FDA for ...

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Boehringer Ingelheim announces FDA and EMA regulatory submission for nintedanib in systemic sclerosis associated ILD

18 March 2019 - Systemic sclerosis, also known as scleroderma, is a rare chronic connective tissue disease. ...

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U.S. FDA accepts BLA filing of Aimmune Therapeutics’ AR101 for peanut allergy

18 March 2019 - If approved, AR101 will be the first medicine for this life-threatening condition. ...

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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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Spectrum Pharmaceuticals provides BLA filing update for Rolontis (eflapegrastim)

15 March 2019 - Spectrum Pharmaceuticals announced today that due to the U.S. FDA's request for additional manufacturing-related information for ...

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Eton Pharmaceuticals submits new drug application for DS-200

14 March 2019 - FDA previously granted DS-200 fast track designation. ...

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Karyopharm announces FDA extension of review period for selinexor new drug application

14 March 2019 - PDUFA action date extended by three months to July 6, 2019. ...

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Bavarian Nordic announces FDA delay in the review of the biologics license application for MVA-BN smallpox vaccine

11 March 2019 - Bavarian Nordic today announced that it has received information from the U.S. FDA that the review ...

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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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Advicenne announces submission of European marketing authorisation application for ADV7103 as treatment for distal renal tubular acidosis

12 March 2019 - Advicenne announces today that it has submitted a marketing authorisation application to tEMA for its lead ...

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Celgene submits application to EMA for ozanimod for the treatment of relapsing-remitting multiple sclerosis

11 March 2019 - New drug application submission to U.S. FDA on track for end of March. ...

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Eisai and Imbrium Therapeutics announce U.S. FDA filing acceptance of new drug application for lemborexant for the treatment of insomnia

11 March 2019 - Eisai Co and Imbrium Therapeutics today announced that the U.S. FDA has accepted for review the ...

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Allergan announces FDA acceptance of new drug application for ubrogepant for the acute treatment of migraine

11 March 2019 - Ubrogepant seeks to be the first oral calcitonin gene-related peptide receptor antagonist for the acute treatment of ...

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TB medicine pretomanid enters regulatory review process in the United States

8 March 2019 - TB Alliance’s new drug application for the novel tuberculosis drug candidate pretomanid has been accepted for ...

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