AbbVie submits regulatory applications to FDA and EMA for upadacitinib (Rinvoq) for the treatment of adults with moderately to severely active ulcerative colitis

16 September 2021 - AbbVie today announced that it has submitted applications seeking approval for upadacitinib (15 mg and 30 mg ...

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ObsEva announces submission of new drug application to U.S. FDA for linzagolix for the treatment of uterine fibroids

15 September 2021 - NDA submission includes positive data from Phase 3 PRIMROSE trials up to 52 weeks on treatment and ...

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PDUFA goal date extension for Nefecon NDA in the U.S.

14 September 2021 - Calliditas Therapeutics today announced that the U.S. FDA has extended the PDUFA goal date for its  ...

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Axsome Therapeutics announces FDA acceptance of new drug application for AXS-07 for the acute treatment of migraine

14 September 2021 - Axsome Therapeutics today announced that the U.S. FDA has accepted for filing the Company’s new drug application ...

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Alnylam submits marketing authorisation application to the European Medicines Agency for investigational vutrisiran for the treatment of hereditary ATTR amyloidosis with polyneuropathy

13 September 2021 - If approved, vutrisiran will provide a new, subcutaneously administered, once quarterly treatment option for patients with hATTR ...

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Mirum Pharmaceuticals submits European marketing authorisation application for maralixibat in Alagille syndrome supported by new positive results from natural history study comparison

13 September 2021 - Natural history analysis shows significant improvement in event-free survival and transplant-free survival. ...

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BeiGene announces U.S. FDA acceptance of biologics license application for tislelizumab in oesophageal squamous cell carcinoma

13 September 2021 - This marks the first ex-China regulatory filing for tislelizumab, following approval in five indications in China. ...

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Myovant Sciences and Pfizer announce FDA acceptance of supplemental new drug application for Myfembree for the management of moderate to severe pain associated with endometriosis

9 September 2021 - FDA PDUFA target action date is 6 May 2022. ...

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Phathom Pharmaceuticals submits two NDAs to U.S. FDA for vonoprazan-based treatment regimens for the treatment of H. pylori infection

8 September 2021 - Phathom Pharmaceuticals announced today that it has submitted two new drug applications to the U.S. FDA for ...

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U.S. FDA accepts for priority review supplemental new drug application for Oxbryta (voxelotor) for the treatment of sickle cell disease in children ages 4 to 11

7 September 2021 - New drug application for Oxbryta dispersible tablets also accepted for priority review. ...

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EMA evaluating data on booster dose of COVID-19 vaccine Comirnaty

6 September 2021 - EMA has started evaluating an application for the use of a booster dose of Comirnaty to be ...

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CStone announces China's NMPA has accepted its new drug application for sugemalimab in the treatment of stage III NSCLC

2 September 2021 - Sugemalimab becomes the world’s first anti-PD-1/PD-L1 monoclonal antibody to significantly improve progression-free survival in patients with stage ...

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Moderna announces submission of data to European Medicines Agency for its COVID-19 vaccine booster

3 September 2021 - mRNA-1273 at 50 µg dose level induced robust antibody responses of more than 40 times against ...

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FDA acceptance for filing of new drug application for trientine tetrahydrochloride for the treatment of Wilson’s disease

2 September 2021 - New drug application supported by positive data from Phase 3 CHELATE clinical trial. ...

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Moderna announces submission of initial data to U.S. FDA for its COVID-19 vaccine booster

1 September 2021 - mRNA-1273 at 50 µg dose level induced robust antibody responses of more than 40x against the ...

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