Alkermes submits new drug application to U.S. FDA for ALKS 3831 for treatment of schizophrenia and bipolar I disorder

19 November 2019 - Alkermes today announced that it has submitted a new drug application to the U.S. FDA seeking ...

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Newron receives FDA rare paediatric disease designation for sarizotan for the treatment of Rett syndrome

19 November 2019 - Newron announced today that the U.S. FDA has granted the rare paediatric disease designation for sarizotan, ...

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Generic drug approvals soar, but patients still go without

19 November 2019 - Brand name makers’ patent action limits release of the lower-price medicines, hindering cost-control efforts. ...

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Orphazyme receives breakthrough therapy designation for arimoclomol in Niemann-Pick disease Type C

19 November 2019 - Orphazyme today announces that the US FDA has granted breakthrough therapy designation for arimoclomol, an investigational drug ...

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FDA accepts Samsung Bioepis’ BLA for SB8 bevacizumab biosimilar candidate

19 November 2019 - Samsung Bioepis today announced that the U.S. FDA has accepted for review the company’s biologics license ...

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In a rare political move, prominent biotech venture capitalists speak out against Pelosi’s drug pricing bill

18 November 2019 - A group of top biotech venture capitalists are issuing a stark warning to Congress: They won’t ...

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Levo Therapeutics receives fast track designation from FDA for intranasal carbetocin for the treatment of Prader-Willi syndrome

18 November 2019 - Levo Therapeutics announced today that the U.S. FDA has granted Fast Track designation for LV-101 (intranasal carbetocin) ...

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Seelos Therapeutics receives FDA fast track designation for intranasal racemic ketamine (SLS-002)

18 November 2019 - Seelos Therapeutics today announced the U.S. FDA has granted fast track designation to its new, investigational intranasal ...

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National MS Society responds to price of new Biogen/Alkermes MS medication Vumerity

13 November 2019 - The FDA recently approved a new medication for relapsing MS, Vumerity, by Biogen and Alkermes.  ...

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FDA approves Pfizer's biosimilar, Abrilada (adalimumab-afzb) for multiple inflammatory conditions

18 November 2019 - Pfizer today announced the United States FDA has approved Abrilada (adalimumab-afzb), as a biosimilar to Humira ...

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Statement from Sarah Yim, acting director of the Office of Therapeutic Biologics and Biosimilars in the FDA’s Center for Drug Evaluation and Research, on FDA’s continued progress facilitating competition in the biologic marketplace with approval of 25th biosimilar product

15 November 2019 - Biological products play an increasingly central role in modern medicine, offering treatments for many serious illnesses.  ...

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Tricida announces FDA acceptance of new drug application for veverimer

14 November 2019 - Tricida announced today that the U.S. FDA has accepted for review its new drug application for ...

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FDA approves first targeted therapy to treat patients with painful complication of sickle cell disease

15 November 2019 - Today, the U.S. FDA approved Adakveo (crizanlizumab-tmca), a treatment to reduce the frequency of vaso-occlusive crisis – ...

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FDA approves new antibacterial drug to treat complicated urinary tract infections as part of ongoing efforts to address antimicrobial resistance

14 November 2019 - The U.S. FDA today approved Fetroja (cefiderocol), an antibacterial drug for treatment of patients 18 years of ...

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FDA approves therapy to treat patients with relapsed and refractory mantle cell lymphoma supported by clinical trial results showing high response rate of tumour shrinkage

14 November 2019 - Today, the U.S. FDA granted accelerated approval to Brukinsa (zanubrutinib) capsules for the treatment of adult patients ...

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