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FDA
This page shows the latest FDA news and features for those working in and with pharma, biotech and healthcare.
FDA approves expanded use of BMS’ Reblozyl in blood disorders
drug. The FDA has cleared Reblozyl (luspatercept) for anaemia in adults with lower-risk MDS with ring sideroblasts – an uncommon form of the cancer characterised by red blood cell with ... Reblozyl got the go-ahead from the FDA last November for
Latest news
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Merck’s Keytruda beats chemo in first-line colorectal cancer
Opdivo (nivolumab) was approved by the FDA in 2017 as a second-line therapy for metastatic colorectal cancer with MSI-H mutations.
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Clinical trial of Gilead’s coronavirus hopeful remdesivir begins in UK
emerged. President Donald Trump hailed the antimalarial’s potential at a press conference last months – ahead of mixed results in a clinical trial – with the FDA clearing them for emergency use
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BMS and bluebird bio file ide-cel CAR-T for multiple myeloma in US
Ide-cel has breakthrough designation from the FDA. Bristol-Myers Squibb and bluebird bio have filed their CAR-T therapy idecabtagene vicleucel to the FDA as a treatment for multiple myeloma, ... Johnson &Johnson’s Darzalex (daratumumab) and
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MHRA raises concerns over fraudulent coronavirus tests
Both the UK and the US have been criticised for their respective lack of testing, although the US Food and Drug Administration (FDA) has recently approved a number of COVID-19
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Amarin shares tumble following Vascepa patent loss
It became the first US Food and Drug Administration (FDA)-approved drug to reduce cardiovascular risk in patients with elevated triglyceride levels as an add-on to maximally tolerated statin therapy. ... is approved by FDA, prevent launch of generic
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Latest Intelligence
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Staying ahead in the era of precision medicine
For example, Lung-MAP, a large-scale umbrella trial in non-small cell lung cancer, was one of the first to involve partnerships between several groups including the FDA, NCI, advocacy
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Alzheimer’s: the search for a cure
A lot is resting on the US Food and Drug Administration’s (FDA) interpretation of the data. ... If, after receiving input from an advisory committee, the FDA decides to approve aducanumab, it will provide an immediate fillip to Biogen.
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20 for 2020 – Five pharma leaders to watch in 2020
2. Stephen Hahn – FDA’s new commissioner. The FDA Commissioner always has a pivotal role to play in the industry, directing policy in the world’s largest pharma market, and with ... A radiation oncologist by training and MD Anderson Cancer Center
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Assessing the value of interim analyses in clinical trials
to gain FDA or EMA approval.
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20 for 2020 – Five pharma companies to watch
Daiichi's partner AZ paid a massive $1.35bn upfront for rights to the drug, and after being given a priority review by the FDA as a treatment for patients with ... knocked back by an FDA advisory committee in 2019 but still in development – and
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Approximately 2 fully matching, plus 131 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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Will COVID-19 necessitate a change in thinking around clinical trials?
For instance, the FDA regulations state:. “Each IRB must follow written procedures for ensuring prompt reporting to the IRB of proposed changes in a research activity, and ensuring that changes in
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The growing clinical importance of patient-reported outcomes (PROs)
Indeed, the Food and Drug Administration (FDA) suggests that companies develop PROs specifically tailored to the disease of interest. ... The FDA is strict on defining the therapeutic benefit and having very clear endpoints.
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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
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OPEN Health’s response to the FDA’s guidance on long term follow up post gene therapy
Written by Gavin Jones, OPEN Health. The FDA has published their industry guidance on the topic of long term follow up (LTFU) post gene therapy.
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Onyx Health Ltd
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
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Approximately 2 fully matching, plus 45 partially matching documents found.
COVID-19 Updates and Daily News
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- Sanofi doses first patient in global Kevzara COVID-19 trial
- Moderna chairman says COVID-19 vaccine could begin phase 2 trials in spring
- Germany's coronavirus infections climb but deaths remain low
- Clinical trial of Gilead’s coronavirus hopeful remdesivir begins in UK
- Novartis donates malaria drug for COVID-19 clinical trials
- Takeda begins development of COVID-19 plasma therapy
- We’re Celebrating Ten Magical Years for Ify at Lucid Group
- NICE publishes new COVID-19 management guidelines
- Servier agrees to buy Symphogen to swell its cancer pipeline
- FDA approves expanded use of BMS’ Reblozyl in blood disorders
- Key emerging trends in digital health
- What challenges still face clinical trial recruitment and retention?
PMHub
JPA Health Communications
JPA Health is an award-winning public relations, marketing and advocacy firm known for sharing our clients’ commitment to making people...
Latest intelligence
- What challenges still face clinical trial recruitment and retention?
- Discover the reasons for the current clinical trial recruitment challenges facing pharma and the life sciences industry, and how the search for solutions to the problem continues...
- “Fake News” and Credibility in Medical Publishing
- Natalie Yeadon from Impetus Digital shares her thoughts on fighting fake news in Pharma and healthcare....
- Delivering true value: what does it mean for KAM in cancer care?
- Lisa Alderson, Business Development Director at Wilmington Healthcare, explores the challenges that pharma’s KAM teams face in engaging with the NHS and how they must evolve...
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