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FDA
This page shows the latest FDA news and features for those working in and with pharma, biotech and healthcare.
AstraZeneca/Sanofi’s RSV antibody backed by FDA advisory committee for infants
AstraZeneca/Sanofi’s monoclonal antibody has been recommended by a US Food and Drug Administration’s (FDA) panel of experts for the prevention of respiratory syncytial virus (RSV) lower respiratory tract ... The FDA will now consider the panel’s
Latest news
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Pfizer’s RSV vaccine approved by FDA for older adults
The approval comes less than a month after the FDA approved GSK’s RSV vaccine, Arexvy, also for adults aged 60 years and older. ... The candidate was recommended for approval last month by an FDA panel of experts, which voted that the available data
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Astellas Pharma’s non-hormonal menopause drug granted FDA approval
The US Food and Drug Administration’s (FDA) decision makes the drug the first non-hormonal neurokinin 3 receptor antagonist approved for this indication. ... The FDA’s decision was supported by positive results from the BRIGHT SKY programme, in which
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FDA advisory committee backs Sarepta’s Duchenne muscular dystrophy gene therapy
A US Food and Drug Administration’s (FDA) panel of experts has recommended Sarepta Therapeutics’ Duchenne muscular dystrophy (DMD) investigational gene therapy for accelerated approval. ... The FDA will now consider the panel’s advice as it makes a
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GSK’s RSV vaccine approved by FDA for older adults
The US Food and Drug Administration’s (FDA) decision makes Arexvy the first RSV vaccine for older adults to be approved anywhere in the world.
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FDA issues new draft guidance on decentralised clinical trials
FDA commissioner, Robert Califf, said: “The FDA has long considered the benefits of DCTs. ... The recommendations come just over a month since the FDA proposed improvements for oncology clinical trials used to support accelerated approval.
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Latest Intelligence
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Pharma’s struggles with social media
Prior to the change in its COVID-19 policy there was enthusiastic backing for staying on Twitter from one high-profile health authority, Dr Robert Califf, commissioner at the US FDA, ... More than ever before, it’s important that the FDA continues to
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Using the power of data to future-proof the clinical development industry
This is despite the FDA’s draft guidance on improving enrolment of underrepresented racial and ethnic populations in clinical trials. ... As the FDA continues to make diversity a priority, not representing the full patient population in the clinical
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Critical success factors and the increasing value of rare disease clinical trials
Rare disease research has massive implications today. Since 2018, big pharma has either acquired or developed 50% of new orphan drugs approved by the FDA.
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Rare diseases: not so rare after all
Incentive offers from regulators such as the Food and Drug Administration (FDA), the European Medicines Agency (EMA) and the Medicines and Healthcare products Regulatory Agency (MHRA) to address unmet medical needs. ... evaluation. This approach is
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Life sciences reimagined
Using the same data model, software and scientific standards per substance class enables increased exchange with the FDA, WHO and other regulators.
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Approximately 2 fully matching, plus 191 partially matching documents found.
Latest appointments
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New faces at Synergy Vision, Makara Health and JPA Health
regional health communications campaigns. In her new role, she will leverage her expertise in FDA/EMA communications, patient and physician education, scientific communications, issues management and celebrity engagement to serve JPA
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New hires at Nanoform, Leo Pharma and Calliditas
The combination of his strong experience in regulatory affairs, not only with the FDA but on a broad international basis with a proven track record and experience from orphan drug development
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Parexel expands global regulatory services team
US-based biopharmaceutical services company Parexel has bolstered its regulatory services team with the addition of three senior executives from the FDA and pharma. ... He has previously worked for the likes of Novartis, Igenix and the FDA.
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NDA Group appoints Alison McGregor as its principal consultant
Johan Stromquist, chief executive officer, NDA Group, said: “The US expansion is our main focus in 2018 and we are planning expanding our support for FDA and EMA submissions, milestone meetings
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Silence Therapeutics appoints Dr Annalisa Jenkins as non-executive chair
Dr Jenkins is also a committee member of the science board to the US Food and Drug Administration (FDA) and serves on the advisory board of its Center for Talent Innovation
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Approximately 6 fully matching, plus 43 partially matching documents found.
Latest from PMHub
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Could femtech be the answer to the gender health gap?
of health (NIH) following a ban by the US FDA.
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The challenges of reimbursement and innovative pricing for cell and gene therapies
It’s important to understand that only a handful of cell and gene therapies have been approved by the FDA, which limits the amount of flexibility for affordability and coverage.
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Rare and Orphan Diseases
In 2022, the FDA approved 37 new medicines – 61 less than the amount approved in 2018; however, the proportion of these new medicines that were drugs to treat rare diseases rose ... References:. Mireku, A. (2023) ‘Can the FDA keep the momentum going
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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
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Precision versus personalised medicine
2022. Cancer Research UK. Monoclonal antibodies. Available at: . Accessed November 2022. AstraZeneca. Small Molecules. Available at: . Accessed November 2022. US FDA. Precision Medicine. Available at: . Accessed November 2022. Marshall CR, et
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Approximately 3 fully matching, plus 84 partially matching documents found.
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- Pfizer reports positive results for elranatamab in multiple myeloma
- Novartis receives EC approval for Cosentyx in hidradenitis suppurativa
- AstraZeneca to stop post-marketing study of Andexxa following early success
- BMS presents positive four-year results for Opdivo combination in lung cancer
- Merck sues US government over Medicare drug price negotiation programme
- GSK’s RSV vaccine approved by EC for older adults
- European Commission grants two new marketing authorisations for UCB's Bimzelx
- AstraZeneca/Sanofi’s RSV antibody backed by FDA advisory committee for infants
- Janssen shares positive phase 3 results for cilta-cel in multiple myeloma
- Parkinson’s disease: past, present and future
- How to Increase Engagement During Virtual Events
- AstraZeneca to stop post-marketing study of Andexxa following early success
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- Examining the history and complexities of Parkinson’s disease – one of the most prevalent neurodegenerative disorders that affects over 10 million people worldwide...
- The 17th World Congress on Controversies in Neurology
- This year, there was a focus on the rare disease neuromyelitis optica spectrum disorder that strikes suddenly and mainly impacts women...
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- In this white paper, our consultants analyze trends spanning global policy developments, rising inflation, and increasingly complex customer journeys, and reveal a new data-driven approach to archetyping that crystalizes the...
