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BioWorld - Wednesday, February 1, 2023
Home » Topics » Regulatory

Regulatory
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Enspryng approved in Japan for adults and children with NMOSD

June 30, 2020
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Product images of Acclaim models 9000 and 9200

FDA grants breakthrough status to Envoy Medical’s Acclaim cochlear implant

June 29, 2020
By Meg Bryant
No Comments
Envoy Medical Corp. got some early support for its Acclaim fully implantable cochlear implant, with a breakthrough device designation from the U.S. FDA. If approved, it would be the first cochlear implant to address hearing loss without the use of any external components.
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Regulatory front for June 29, 2020

June 29, 2020
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The latest global regulatory news, changes and updates affecting medical devices and technologies, including: ACLA, I-Fixit, MITA, Palmetto GBA.
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Regulatory actions for June 29, 2020

June 29, 2020
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Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Beckman Coulter, Boston Scientific, Envoy Medical, Orthofix.
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FDA Not Approved stamp

Heron knocked by second CRL for postoperative pain drug

June 29, 2020
By Randy Osborne
No Comments
Shares of Heron Therapeutics Inc. sank 27% in morning trading, after the San Diego-based firm disclosed a second complete response letter (CRL) for HTX-011 in postoperative pain. The CRL, received from the FDA on June 26, the anticipated PDUFA date, stated the agency was unable to approve the NDA in its present form and called for additional nonclinical information.
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Intercept watches adcom dates, PDUFAs slide by as it receives CRL for OCA in NASH

June 29, 2020
By Lee Landenberger
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Toss a complete response letter (CRL) onto two missed PDUFA dates and a few adcoms that were discussed but never actualized to get an idea of where Intercept Pharmaceuticals Inc. now stands with its NDA for obeticholic acid (OCA) to treat fibrosis due to nonalcoholic steatohepatitis (NASH).
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Regulatory front for June 29, 2020

June 29, 2020
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The latest global regulatory news, changes and updates affecting biopharma.
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Regulatory actions for June 29, 2020

June 29, 2020
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Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Alexion, Aptose, Aquestive, Cancer Prevention, Cytocom, Emmaus, Genentech, Goliver, Heron, Incyte, Intercept, Merz, Nordic Nanovector, Novartis, PTC, Rakuten, Roche, Rocket, SFA, Teijin.
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Japan first to approve Duvroq for anemia due to chronic kidney disease

June 29, 2020
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FDA approves Mycapssa for long-term maintenance treatment in patients with acromegaly

June 29, 2020
No Comments
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