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Food and Drug Administration

This page shows the latest Food and Drug Administration news and features for those working in and with pharma, biotech and healthcare.

New data from Moderna supports COVID boosters

New data from Moderna supports COVID boosters

Ahead of the meeting of the Food and Drug Administration’s advisory committee in two weeks’ time, the new analysis “adds to evidence of potential benefit of a booster dose of ... mRNA-1273 had a vaccine effectiveness of 87% against COVID-19

Latest news

  • US orders 1.4 million more doses of Regeneron antibody cocktail US orders 1.4 million more doses of Regeneron antibody cocktail

    REGEN-COV has not been approved by the Food and Drug Administration but was made available in November 2020 under emergency use approval for the treatment of COVID-19. ... COVID-19, including hospitalisation or death, and who have been in close contact

  • Orphan status in Europe for lymphoma drug Zynlonta Orphan status in Europe for lymphoma drug Zynlonta

    Lausanne-based biotech ADC Therapeutics has received orphan drug designation in the European Union for its antibody-drug conjugate Zynlonta four months after approval by the Food and Drug Administration. ... Zynlonta is a CD19-directed antibody drug

  • Sanofi boosts transplant portfolio with newly approved Rezurock Sanofi boosts transplant portfolio with newly approved Rezurock

    Just weeks after the surprise approval of Kadmon Holdings’ Rezurock (belumosudil) by the Food and Drug Administration (FDA), Sanofi has announced it will acquire the biopharmaceutical company. ... Kadmon’s pipeline includes drug candidates for immune

  • FDA pauses BioMarin gene therapy trial FDA pauses BioMarin gene therapy trial

    The US Food and Drug Administration (FDA) has placed a clinical hold on the phase 1/2 Phearless study investigating BMN 307, a gene therapy from California-based rare disease biotech, ... The translatability of these findings to humans is uncertain and

  • Congress “concerned by apparent anomalies” around FDA’s approval of Aduhelm Congress “concerned by apparent anomalies” around FDA’s approval of Aduhelm

    Congress demands more information from the FDA on its controversial approval of Biogen’s Alzheimer’s drug and its dealings with the company. ... It has been a tough summer for the US Food and Drug Administration (FDA).

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Latest Intelligence

  • How early-stage clinical research is facilitating the new wave of personalised medicines How early-stage clinical research is facilitating the new wave of personalised medicines

    The first ever siRNA therapy was only approved by the US Food and Drug Administration (FDA) in 2018 – Patisiran for the treatment of the nerve disease (polyneuropathy) – and two further siRNA ... Delivering trials directly to the target population

  • Diversity and inclusion in clinical trials Diversity and inclusion in clinical trials

    consideration diverse populations to better understand the benefits and associated risks across all groups. ... Regulation providing the framework for the future. In November 2020, the US Food and Drug Administration (FDA) issued new guidance to provide

  • Piloting a route to the biosimilars opportunities in Europe Piloting a route to the biosimilars opportunities in Europe

    In addition, national drug authorities across Europe, as well as the Heads of Medicines Agencies (CMDh), have been making similar efforts to provide access to biosimilars. ... The US Food and Drug Administration (FDA) is catching up quickly too,

  • Alzheimer’s: the search for a cure Alzheimer’s: the search for a cure

    The aducanumab data is still under review by the US Food and Drug Administration (FDA), and a decision about granting marketing authorisation is expected in June. ... And that’s definitely good news for all of us. Peter Schueler is a Neurologist and Sr

  • The search for effective drug treatments for COVID-19 The search for effective drug treatments for COVID-19

    to find an effective drug treatment for patients and the journey of remdesivir that began a decade ago as part of Gilead’s emerging viruses programme. ... What were the trial results that led to this EUA? An EUA is a mechanism through which the Food

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Latest appointments

  • Parexel expands global regulatory services team Parexel expands global regulatory services team

    Robert Iser joins Parexel as its vice president of regulatory consulting service from his post as director of the Food and Drug Administration’s ( FDA) Office of Process and Facilities. ... He brings a decade of experience leading global oncology and

  • Silence Therapeutics appoints Dr Annalisa Jenkins as non-executive chair Silence Therapeutics appoints Dr Annalisa Jenkins as non-executive chair

    forchief executive officer, Silence Therapeutics, said: “Annalisa’s extensive and broad experience in all aspects of biotechnology, drug development and commercialisation will prove to be invaluable. ... Dr Jenkins is also a committee member of the

  • AZ and Medimmune bolsters immuno-oncology leadership AZ and Medimmune bolsters immuno-oncology leadership

    patients. He most recently served the US Food and Drug Administration (FDA) as its director, division of oncology products in the office of haematology oncology products since 2015 and also had ... Prior to joining MedImmune, he served as a professor of

  • Constellation Pharmaceuticals strengthens management team Constellation Pharmaceuticals strengthens management team

    Prior to his time at Puma, Senderowicz held several roles for the life sciences sector including team leader at the US Food and Drug Administration (FDA), vice president, global regulatory oncology ... His background in drug development and the

  • Greenleaf Health appoints drug and biological products principal Greenleaf Health appoints drug and biological products principal

    Dr John Jenkins joins the FDA regulatory consulting firm. Washington, US-based Greenleaf Health has appointed Dr John Jenkins as principal for drug and biological products. ... Dr Jenkins brings over 25 years of experience from the US Food and Drug

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Latest from PMHub

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