Please login to the form below
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.
Novartis announces positive phase 3 trial results for advanced oesophageal cancer
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
Latest news
-
EMA grants Bavarian Nordic access to PRIME scheme for RSV vaccine candidate
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
-
Eli Lilly to supply US government with 150,000 additional doses of bebtelovimab
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
-
Pfizer and BioNTech sign $3.2bn COVID-19 vaccine supply agreement with US government
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.
-
Dermavant publishes positive phase 3 data for treatment of plaque psoriasis
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
-
FDA issues innovative proposal to increase nonprescription drug access
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
More from news
Approximately 14 fully matching, plus 1,670 partially matching documents found.
Latest Intelligence
-
Listen, learn and lift off
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
-
Expanding clinical trial access: a global imperative requiring local focus
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
-
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
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
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,
More from intelligence
Approximately 0 fully matching, plus 31 partially matching documents found.
Latest appointments
-
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
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
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
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
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
More from appointments
Approximately 0 fully matching, plus 13 partially matching documents found.
Latest from PMHub
-
Diversity in Clinical Trials: A more inclusive approach in patient recruitment
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
-
What NORD’s RareInsights® 30-year comparative analysis means to us and our clients at OPEN Health
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:.
-
If our patients are diverse, why are clinical trials so white?
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 receives clearance from the FDA to proceed with the clinical investigation of BB2603
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
-
ahair@onyxhealth.com
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
More from PMHub
Approximately 0 fully matching, plus 9 partially matching documents found.
Subscribe to our email news alerts
Featured jobs
- Medical Writer, MRNA/ Covid 19, Medical Communications, UK
-
Highly competitive salary
- Senior Analyst, Market Access, UK, Home based
-
Highly competitive salary
- Vice President, Medical Communications, UK, six figure package
-
Six figure salary
- Scientific Strategy Lead, Medical Communications, UK
-
Highly competitive salary
- New Omicron sub-variants cause COVID-19 cases to rise in the UK
- Sanofi Global Health unveils new nonprofit Impact brand
- Innovative Health Initiative launches first two calls for proposals to tackle ‘biggest’ health research challenges
- NHS App to revolutionise digital health and care with major digital updates by 2023
- Pfizer announces commitment to achieve Net-Zero Standard by 2040
- Novartis announces positive phase 3 trial results for advanced oesophageal cancer
- The Power of AI in Medical Education
- First evidence-based guide launched to put patients at heart of digital innovations
- FDA grants Priority Review for Biogen and Eisai’s lecanemab for early Alzheimer’s disease
- New Swiss research reveals how Omicron evades the immune system
- Evoke Kyne Named Communiqué Communications Consultancy of the Year 2021
- Michael Grela Elected President of the Society for Health Communication
- First evidence-based guide launched to put patients at heart of digital innovations
- Roche shares new positive Ocrevus data for MS patients
- FDA grants Priority Review for Biogen and Eisai’s lecanemab for early Alzheimer’s disease
- A creative awakening – how pharma is bringing innovation to the patient journey
- Country report: The healthcare market in South Korea
- European Commission approves potential new treatment for Pompe disease
PMHub
Lucid Group Communications Limited
WE’RE ON A MISSION
To transform lives through communication that changes behaviour and improves health outcomes....
Latest intelligence
- Five big changes in the healthcare comms landscape
- The world of healthcare has changed very greatly in the five years since The Difference Collective launched. Our agile model and talented team have enabled us to keep pace with...
- Early communications in Pharma: How effective pre-approval comms delivers launch success
- What communications are required for a successful launch...
- Our Top 5 Pharma Picks From Cannes Lions
- Here are five of Art's top five pharma and healthcare picks from Cannes Lions 2022....
