This page shows the latest Food and Drug Administration news and features for those working in and with pharma, biotech and healthcare.
The treatment is currently under review by the US Food and Drug Administration (FDA) and the European Medicines Agency (EMA) for relapsed oesophageal cancer, with the FDA due to deliver its ... The EMA is also reviewing the drug for advanced or
RSV is a common and pervasive seasonal respiratory illness that is highly contagious. ... In February 2022, the US Food and Drug Administration (FDA) granted Breakthrough Therapy Designation for MVA-BN RSV, for active immunisation for prevention of LRTD
The antibody drug treatment has thus far only been authorised for emergency use by the FDA to treat COVID-19 in specific emergency cases in non-hospital settings. ... Bebtelovimab has not been approved, but has been given an Emergency Use Authorisation
COVID-19 vaccines, subject to authorisation from the US Food and Drug Administration (FDA). ... Vaccines have been and will remain critical to protecting people of all ages against COVID-19.
In May, Dermavant announced that the US Food and Drug Administration (FDA) had granted approval of Vtama 1% cream to treat adults with plaque psoriasis, an approval which meant Vtama cream ... our PSOARING 3 40-week extension efficacy and safety study of
The US Food and Drug Administration (FDA) has issued an innovative proposal intended to increase consumer access to nonprescription drugs. ... Currently, nonprescription drug treatments are limited to ones that provide sufficient information that allows
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remains. Yet, anxiety swirls around strategising commercial drug launches through harnessing patient insights and data, identifying client segments, timings and the new generation of omnichannel options. ... The US Food and Drug Administration (FDA) and
We have particularly focused efforts on meeting the Food and Drug Administration’s expectations (see guidance for reflecting the demographics of treatment populations and collecting race and ethnicity data in trials). ... trial design and planning and
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
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
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,
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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
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
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
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
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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recruitment. Between 2008 and 2018, fewer than two in three (63%) of the 230 clinical trials that led to cancer drug approvals by the Food and Drug Administration (FDA) in the ... This session will highlight some of the factors underpinning the lack of
In addition to this there has been a huge increase in the number of orphan treatments granted access by the US Food and Drug Administration (FDA) (862 vs 46) but this ... To maximise this constructive direction of travel we recommend innovators:.
One of the endpoints of the trial was a progression free survival (PFS) of 6 months, leading to Ninlaro’s Food and Drug Administration approval in 2015. ... One of these is Darzalex, another drug for multiple myeloma that is indicated across all lines
Blueberry Therapeutics has received an investigational new drug (IND) clearance from the Food and Drug Administration (FDA) to proceed with the clinical development of BB2603. ... Alderley Park, UK, January 2020. Blueberry Therapeutics has received an
Onyx Health is made up of thirteen creative and strategic thinkers who are driven to succeed. ... Blueberry Therapeutics has received an investigational new drug (IND) clearance from the Food and Drug Administration (FDA) to proceed with the clinical
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