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RSS FeedPosted by Michael Wonder on 27 Feb 2020
Ultragenyx and Kyowa Kirin announce FDA acceptance and priority review designation of supplemental biologics license application for Crysvita (burosumab) for tumour-induced osteomalacia
27 February 2020 - Ultragenyx Pharmaceutical and Kyowa Kirin Co today announced that the U.S. FDA has accepted for review the ...
Posted by Michael Wonder on 27 Feb 2020
Zogenix announces FDA extension of review period for Fintepla in Dravet syndrome
27 February 2020 - Zogenix today announced that the U.S. FDA has extended the review period for the new drug application ...
Posted by Michael Wonder on 26 Feb 2020
FDA launches new interactive, PDF-based, template to promote greater efficiency and consistency in preparation and review of 510(k) medical device applications
26 February 2020 - Today, the U.S. FDA is announcing the voluntary electronic Submission Template And Resource (eSTAR) Pilot Program as ...
Posted by Michael Wonder on 26 Feb 2020
Translate Bio receives FDA fast track designation for MRT5005 for the treatment of cystic fibrosis
26 February 2020 - First inhaled mRNA therapeutic remains on track to report results from its ongoing multiple-ascending dose portion of ...
Posted by Michael Wonder on 26 Feb 2020
Puma Biotechnology receives U.S. FDA approval of supplemental new drug application for neratinib to treat HER2-positive metastatic breast cancer
26 February 2020 - Puma Biotechnology announced that the U.S. FDA approved a supplemental new drug application for neratinib in combination ...
Posted by Michael Wonder on 25 Feb 2020
Perrigo and Catalent announce FDA approval of Perrigo's AB-rated generic version of ProAir HFA
24 February 2020 - Perrigo and its partner, Catalent Pharma Solutions, today announced that the U.S. FDA has approved Perrigo's abbreviated ...
Posted by Michael Wonder on 25 Feb 2020
Lysogene receives FDA fast track designation for LYS-SAF302 gene therapy in MPS IIIA
25 February 2020 - 17th patient dosed in the ongoing phase 2/3 AAVance study. ...
Posted by Michael Wonder on 25 Feb 2020
FDA accepts Genentech’s biologics license application for fixed-dose subcutaneous combination of Perjeta and Herceptin for HER2-positive breast cancer
24 February 2020 - Fixed-dose combination is administered under the skin in just minutes, compared to hours with intravenous administration, significantly ...
Posted by Michael Wonder on 25 Feb 2020
FDA approves first generic of ProAir HFA
24 February 2020 - Agency supports development of complex generic drugs to improve competition and access to more affordable medicines. ...
Posted by Michael Wonder on 24 Feb 2020
Seqirus receives FDA approval for Fluad Quadrivalent (influenza vaccine, adjuvanted) for adults 65 years and older
24 February 2020 - Designed with MF59 adjuvant to help strengthen, broaden and lengthen the body's immune response against the influenza ...
Posted by Michael Wonder on 24 Feb 2020
ContraFect announces U.S. FDA grants breakthrough therapy designation to exebacase for the treatment of Methicillin-resistant Staphylococcus aureus (MRSA) bacteraemia, including right-sided endocarditis
24 February 2020 -- ContraFect today announced that that the U.S. FDA has granted breakthrough therapy designation to exebacase for ...
Posted by Michael Wonder on 24 Feb 2020
U.S. FDA accepts GSK’s application for Zejula (niraparib) for first-line maintenance treatment for women with platinum-responsive advanced ovarian cancer
24 February 2020 - Submission based on data from the Phase III PRIMA clinical study that demonstrated clinically-meaningful outcomes of niraparib ...
Posted by Michael Wonder on 24 Feb 2020
Takeda announces U.S. FDA grants priority review for supplemental new drug application for Alunbrig (brigatinib) as a first-line treatment for ALK+ metastatic non-small cell lung cancer
25 February 2020 - Prescription Drug User Fee Act target action date set for 23 June 2020. ...
Posted by Michael Wonder on 24 Feb 2020
Teva announces FDA approval of ArmonAir Digihaler (fluticasone propionate) inhalation powder
24 February 2020 - Teva’s digital inhaler portfolio now includes products from three of the most commonly prescribed classes of ...
Posted by Michael Wonder on 24 Feb 2020
FDA launches new Purple Book searchable database to help patients and prescribers identify FDA-approved biologic and biosimilar treatment options
24 February 2020 - Today, the FDA is releasing the first phase of the enhancement of the “Purple Book: Database of ...