Janssen receives Health Canada approval of Balversa (erdafitinib), the first FGFR kinase inhibitor for the treatment of patients with locally advanced or metastatic urothelial carcinoma with certain FGFR genetic alterations

24 February 2020 - Diagnostic testing is available to identify which patients are most likely to benefit from BALVERSA, offering a ...

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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 ...

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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. ...

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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 ...

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EMA publishes agenda for 24-27 February CHMP meeting

25 February 2020 - The EMA has published a draft agenda for this week's CHMP meeting. ...

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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. ...

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Brexit - implications for therapeutic goods in Australia

25 February 2020 - A transition period is in effect until the end of 2020 while the UK and EU negotiate ...

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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 ...

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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 ...

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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 ...

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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. ...

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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 ...

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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 ...

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Real world evidence - from safety to a potential tool for advancing innovative ways to develop new medical therapies

24 February 2020 - Real world evidence has the potential to enhance the efficiency of drug development and provide new evidence ...

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Novartis announces FDA and EMA filing acceptance of ofatumumab, a novel B-cell therapy for patients with relapsing forms of multiple sclerosis

24 February 2020 - Filings are supported by Phase III ASCLEPIOS I and II studies, where ofatumumab showed highly significant and ...

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