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FDA Breakthrough Therapy Designation
This page shows the latest FDA Breakthrough Therapy Designation news and features for those working in and with pharma, biotech and healthcare.
Moderna/Merck’s skin cancer therapy given FDA breakthrough therapy designation
Moderna and Merck – known as MSD outside the US and Canada – have said their investigational personalised mRNA cancer vaccine, in combination with Merck’s Keytruda, has been given breakthrough therapy designation ... A breakthrough therapy
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Pfizer’s multiple myeloma treatment granted FDA Breakthrough Therapy Designation
Pfizer’s investigational cancer immunotherapy, elranatamab, has received a Breakthrough Therapy Designation from the US Food and Drug Administration (FDA) for the treatment of relapsed or refractory multiple myeloma (RRMM), the ... cancer.”. In
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Sanofi and Sobi’s efanesoctocog alfa granted FDA priority review for haemophilia A
The treatment was granted Breakthrough Therapy Designation by the FDA in May 2022, having received Fast Track designation in February 2021 and Orphan Drug designation in August 2017. ... Commenting on the FDA’s decision, Steve Pipe, professor and
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Pfizer announces positive phase 3 results of RSV vaccine candidate in older adults
Based on these results, Pfizer plans to submit a Biologics Licence Application (BLA) to the US Food and Drug Administration (FDA) for RSVpreF and to prepare submissions for other regulatory authorities ... In addition to the investigational older adult
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EMA grants Bavarian Nordic access to PRIME scheme for RSV vaccine candidate
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 caused by RSV in adults aged ... These grants highlight the potential of our vaccine to
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Pfizer receives Breakthrough Therapy Designation from FDA for RSV vaccine candidate
Pfizer has announced that the US Food and Drug Administration (FDA) has granted its respiratory syncytial virus (RSV) vaccine candidate a Breakthrough Therapy Designation. ... The purpose of the FDA’s Breakthrough Therapy Designation is to efficiently
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Bluebird Bio: on the cusp of a gene therapy revolution
There is no question that these products are truly groundbreaking: three have FDA Breakthrough Therapy Designation and two have the similar PRIME designation from the EMA. ... The sickle cell programme has also been named on the FDA’s Regenerative
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Deal Watch February 2017
IMMU-132 has FDA Breakthrough Therapy designation for the treatment of patients with TNBC who have failed prior therapies for metastatic disease and also has Fast Track status and orphan designation ... Licence. 145. Sarepta Therapeutics/ Gilead Sciences.
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Interview: AstraZeneca's Susan Galbraith
What selumetinib does is potentially deliver a new targeted therapy into an area where there aren't any targeted therapies,” says Galbraith. ... This drug has recently received Breakthrough Therapy designation from the US FDA and phase 1 data will be
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