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RSS FeedPosted by Michael Wonder on 20 Nov 2019
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 ...
Posted by Michael Wonder on 20 Nov 2019
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, ...
Posted by Michael Wonder on 20 Nov 2019
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. ...
Posted by Michael Wonder on 19 Nov 2019
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 ...
Posted by Michael Wonder on 19 Nov 2019
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 ...
Posted by Michael Wonder on 19 Nov 2019
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 ...
Posted by Michael Wonder on 18 Nov 2019
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) ...
Posted by Michael Wonder on 18 Nov 2019
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 ...
Posted by Michael Wonder on 18 Nov 2019
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. ...
Posted by Michael Wonder on 18 Nov 2019
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 ...
Posted by Michael Wonder on 18 Nov 2019
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. ...
Posted by Michael Wonder on 17 Nov 2019
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 ...
Posted by Michael Wonder on 15 Nov 2019
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 – ...
Posted by Michael Wonder on 14 Nov 2019
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 ...
Posted by Michael Wonder on 14 Nov 2019
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 ...