U.S. FDA accepts new drug application and grants priority review for darolutamide

29 April 2019 - Bayer today announced the U.S. FDA has accepted the new drug application and granted priority review to ...

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Priority review vouchers have helped to improve access to drugs targeting neglected diseases

22 April 2019 - The FDA priority review vouchers for neglected tropical diseases are aimed to incentivise pharmaceutical companies to ...

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Novartis announces FDA filing acceptance and priority review of brolucizumab (RTH258) for patients with wet AMD

15 April 2019 - Filing is based on Phase III data from the HAWK and HARRIER trials for brolucizumab. ...

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Polyphor's antibiotic murepavadin receives US FDA qualified infectious disease product designation in four new indications

12 April 2019 - Polyphor's antibiotic murepavadin receives US FDA qualified infectious disease product designation in four new indications. ...

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Daiichi Sankyo’s EZH1/2 dual inhibitor valemetostat (DS-3201) receives SAKIGAKE designation for treatment of patients with relapsed/refractory peripheral T-cell lymphoma from Japan MHLW

9 April 2019 - SAKIGAKE designation will provide development support and accelerated review of valemetostat, an investigational and potential first-in-class EZH1/2 ...

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EMA grants PRIME designation to Janssen’s investigational CAR-T therapy

4 April 2019 - Johnson & Johnson’s Janssen has announced the granting of a PRIME (PRIority MEdicines) designation for its ...

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EMA grants PRIME eligibility for KB103 to treat dystrophic epidermolysis bullosa

29 March 2019 - First EMA PRIME eligibility for Krystal Biotech. ...

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Enzyvant's investigational Farber disease enzyme replacement therapy, RVT-801, receives FDA fast track and rare paediatric disease designations

21 March 2019 - Enzyvant today announced that the U.S. FDA has granted are paediatric disease and fast track designations for ...

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Iterum Therapeutics receives QIDP for oral and IV sulopenem in four additional indications as well as fast track designation

19 March 2019 - New designations in community-acquired bacterial pneumonia, acute bacterial prostatitis, gonococcal urethritis, and pelvic inflammatory disease demonstrate the ...

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Biohaven secures priority review voucher to expedite regulatory review of Rimegepant Zydis ODT new drug application

18 March 2019 - Rimegepant Zydis orally disintegrating tablet is Biohaven's lead oral CGRP receptor antagonist drug candidate from its Nojection ...

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GW Pharmaceuticals announces the sale of priority review voucher for $105 million

18 March 2019 - GW Pharmaceuticals today announced that GW Research Ltd. has entered into a definitive agreement to sell its ...

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FDA to undertake priority review of Dupixent (dupilumab) for adults with inadequately controlled severe chronic rhinosinusitis with nasal polyps

8 March 2019 - The U.S. FDA has accepted for priority review the supplemental biologics license application for Dupixent (dupilumab) as ...

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FDA grants rare paediatric disease designation to odiparcil for the treatment of MPS VI

5 March 2019 - Inventiva eligible to receive priority review voucher upon approval of odiparcil for the treatment of MPS VI. ...

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U.S. FDA grants priority review for fedratinib new drug application in myelofibrosis

5 March 2019 - U.S. FDA sets Prescription Drug User Fee Act action date for 3 September 2019. ...

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Lilly receives FDA priority review designation for Emgality (galcanezumab-gnlm) injection for the preventive treatment of episodic cluster headache in adults

5 March 2019 - Eli Lilly and Company announced today that the U.S. FDA has granted priority review for its ...

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