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FDA Breakthrough Therapy Designations 2018
This page shows the latest FDA Breakthrough Therapy Designations 2018 news and features for those working in and with pharma, biotech and healthcare.
FDA awards another non-opioid pain drug breakthrough status
The US regulator yesterday awarded Concentric Analgesics and its pipeline drug CA-008 in post-surgical pain with an FDA Breakthrough Therapy designation (BTD). ... The Breakthrough Therapy designation is based on phase Ib placebo-controlled clinical
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- Novavax announces further delays for regulatory filings of COVID-19 vaccine
- Merck signs $1.2bn supply deal with US government for Molnupiravir
- Novartis highlights potential of its radioligand therapy in prostate cancer at ASCO
- AZ, Pfizer/BioNTech COVID-19 vaccines 'highly effective' against Indian variant
- Novartis’ iptacopan scores positive results in rare blood disorder PNH
- Sanofi’s C1s inhibitor sutimlimab hits the mark in late-stage CAD study
- Kite partners with Shoreline Biosciences to develop allogeneic cell therapies
- Fishawack Health acquires digital marketing agency closerlook
- Biotech Innovation in the Time of COVID-19
- Using Technology to Improve Patient Experience
- Disappointing results from CureVac’s COVID-19 vaccine as phase 2/3 study shows only 47% efficacy
- Biogen discontinues clinical development of anti-tau antibody for Alzheimer’s disease
- Diversity and inclusion in clinical trials
- Merck signs $1.2bn supply deal with US government for Molnupiravir
- Nicky Hutchens appointed as deputy managing director at Four Health
- EMA authorises Pfizer/BioNTech’s COVID-19 vaccine for children aged 12 to 15
- FDA lifts clinical hold on bluebird bio’s LentiGlobin studies
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