Please login to the form below
US Food and Drug Administration
This page shows the latest US Food and Drug Administration news and features for those working in and with pharma, biotech and healthcare.
AbbVie’s Parkinson’s disease therapy application rejected by FDA
AbbVie has announced that its Parkinson’s disease therapy has not been approved by the US Food and Drug Administration (FDA), which has requested more information on the pump used to ... Approximately 130 adult participants with Parkinson's, whose
Latest news
-
Roche and Eli Lilly to collaborate on Alzheimer’s disease blood test
The partnership comes just two months after Eisai and Biogen’s Alzheimer’s drug Leqembi (lecanemab-irmb) received accelerated approval in the US for patients at early stages of the disease, ... The decision from the US Food and Drug Administration
-
Pfizer pays Royalty Pharma $475m following US approval of migraine nasal spray
Pfizer has given Royalty Pharma an accelerated $475m milestone payment following the US approval of its migraine nasal spray, Zavzpret (zavegepant). ... Pablo Legorreta, founder and chief executive officer of Royalty Pharma, said: “We are pleased that
-
Dermavant reports positive phase 3 results for Vtama cream in atopic dermatitis
More commonly referred to as eczema, atopic dermatitis is one of the most common inflammatory skin diseases, affecting over 26 million people in the US alone and up to 10% of ... With the US Food and Drug Administration’s approval of Vtama in May last
-
Pfizer/BioNTech’s Omicron-adapted booster approved by FDA for young children
Pfizer and BioNTech’s Omicron BA.4/BA.5-adapted bivalent COVID-19 vaccine has been authorised by the US Food and Drug Administration (FDA) for emergency use as a single ... Pfizer and BioNTech said that, in addition to their US application, they have
-
Biogen and Eisai’s Alzheimer’s drug to be covered by US Veterans Health Administration
Biogen and Eisai have announced that their Alzheimer’s drug, Leqembi (lecanemab-irmb), will be covered by the US Veterans Health Administration (VHA). ... The VHA's careful consideration and timely action to make Leqembi available approximately two
More from news
Approximately 35 fully matching, plus 1,623 partially matching documents found.
Latest Intelligence
-
The challenges of identifying rare diseases
According to a National Organization for Rare Disorders (NORD) report from 2020, as of 1 January 2020, 564 orphan products had been approved by the US Food and Drug Administration (FDA) ... By applying a simple proportion, 7.7-8% of rare diseases have an
-
Digital technology: a significant change in healthcare innovation
By Megan Allen. What is digital healthcare? The US Food and Drug Administration (FDA) defines digital health technology as the use of ‘computing platforms, connectivity, software, and sensors’ for healthcare-related ... This type of innovation has
-
Addressing the diversity issue in clinical trials
The European Medicines Agency (EMA) updated its Clinical Trials Regulation to ensure sponsors justify any non-representative procedures in January this year; this was followed by the US Food and Drug ... Administration (FDA), which issued new guidance on
-
How telemonitoring can revolutionise the way we treat patients
The data is transferred to us in real time via a mobile cellular network, allowing doctors to observe sudden changes in weight, which are frequently a sign of worsening (decompensated) heart ... Ultimately, this will not only make medicine development
-
Rare disease drug development – real-world evidence innovations with historical controls
The application of Bayesian methodology has been recognised by the US Food and Drug Administration (FDA) as useful in early phase clinical trials involving paediatric populations. ... Regulatory and payer guidance. Regulatory agencies in the US and
More from intelligence
Approximately 0 fully matching, plus 28 partially matching documents found.
Latest appointments
-
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
-
Dr Andrew Mulberg moves from FDA to Amicus Therapeutics
He joins Amicus from the US Food and Drug Administration ( FDA), where he most recently served as deputy director of the division of gastroenterology and inborn errors products. ... Andrew will be instrumental in shaping our regulatory strategies from
More from appointments
Approximately 0 fully matching, plus 10 partially matching documents found.
Latest from PMHub
-
End-to-end patient strategy: Making a treatment for patients, with patients
According to the US Food &Drug Administration (FDA):. Patient-focused drug development (PFDD) is a systematic approach to help ensure that patients’ experiences, perspectives, needs, and priorities are captured and meaningfully ... Available at
-
The promised land of gene therapy: Commercialization of novel gene-editing technology in beta-thalassemia
patients and families affected by devastating diseases such as sickle cell disease and thalassemia. ... Earlier this year, the US Food and Drug Administration (FDA) approved the first potentially curative gene therapy to treat beta-thalassemia.
-
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 ... US, recorded participants’ ethnicity.
-
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:.
-
Parachuting Behind Enemy Lines: OncoSec’s Attack on Visceral Tumors via Its New Visceral Lesion Applicator (VLA)
Poster 717/Abstract 11375. 15. US Food and Drug Administration. Drugs. FDA grants accelerated approval to nivolumab for HCC previously treated with sorafenib. ... Accessed March 5, 2019. US Food and Drug Administration. Drugs. FDA grants accelerated
More from PMHub
Approximately 0 fully matching, plus 6 partially matching documents found.
Subscribe to our email news alerts
-
Omnichannel Account Director
- £55,000 - £65,000 yearly
- Associate Director - Global Healthcare Consulting
- Highly competitive salary
- Strategy Director - Healthcare Advertising
- Highly competitive salary
-
Pharmacovigilance Project Lead
- Highly competitive salary
-
Pharmacovigilance Manager
- Highly competitive salary
- Early Access Program - Regulatory Affairs (EAP-RA)
- Highly competitive salary
-
Senior Medical Writer
- Highly competitive salary
-
Technical Sales Representative
- Highly competitive salary
- Novo Nordisk suspended from ABPI over ‘serious’ code of practice breaches
- Roche and Eli Lilly to collaborate on Alzheimer’s disease blood test
- MHRA to introduce new UK clinical trials framework
- Pfizer pays Royalty Pharma $475m following US approval of migraine nasal spray
- Team ITG appoints Gerhard Arnhofer as head of customer strategy for life sciences division
- 2023 PM Society Awards – winners announced
- AstraZeneca/MSD’s Lynparza combination approved in UK for prostate cancer
- WHO report highlights impact of COVID-19 pandemic on non-communicable diseases
- Critical success factors and the increasing value of rare disease clinical trials
- Quantum Computing, Artificial Intelligence, & Machine Learning for Drug Discovery
- Novo Nordisk and Dewpoint partner on insulin resistance drug candidates
- AbbVie’s Parkinson’s disease therapy application rejected by FDA
- Team ITG appoints Gerhard Arnhofer as head of customer strategy for life sciences division
- Locus Biosciences announces first patient treated in urinary tract infection trial
- GSK reports positive phase 3 results for five-in-one meningococcal vaccine candidate
- Kite reports positive three-year results for CAR T-cell therapy in rare blood cancer
- Results for Astellas’ non-hormonal menopause drug published in The Lancet
- Ketchum appoints Conor Nash as global chief financial officer and chief operating officer
PMHub
Springer Nature
Operating in 50+ countries, we’re a leading research, educational, and professional publisher dedicated to advancing scientific discovery. Whether you’re looking...
Latest intelligence
- Rare diseases: not so rare after all
- The brave new world addressing rare diseases – a way ahead to better and more inclusive treatment...
- Webinar: Evolving Patient Journeys - How to generate deeper insights in a changing healthcare landscape
- Register now for part one in a series, Evolving Patient Journeys, in which our experts look at the main ways in which the patient journey has evolved in recent years....
- DIGITAL EXPERIENCES: LEARNINGS FROM OUTSIDE PHARMA
- It’s long been the case that pharma lags behind other industries when it comes to digital adoption and engagement. So, what can we learn from these other industries, and how...
