Gilead Sciences, Inc.
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Latest From Gilead Sciences, Inc.
Gilead Keeps Focus On HIV, Long-Acting Drugs And Growth Through Oncology
Even with top-seller Biktarvy and its preventive therapy, Descovy, protected beyond this decade from generics, Gilead is investing aggressively in long-acting HIV candidates and its oncology pipeline.
China Approves Two More Home-Grown COVID-19 Antivirals
Top-line results for two newly approved COVID-19 antivirals in China showed roughly 1.5- to two-day cuts in median time to symptom resolution or recovery in mild-to-moderate Omicron patients versus placebo.
End Of US FDA’s Very Fast Reviews? 2022 Novel Approvals Stayed Close To PDUFA Timeframes
Moderation was a theme of the year in novel approvals, as CDER’s median review time rose for the first time in five years and even the center’s fastest approval took more than seven months. A Pink Sheet infographic breaks down which review pathways did the best last year.
As COVID Public Health Emergency Winds Down, US FDA Employs Flexibility For Rx EUA Transitions
Biden administration sets May 11 as end date for public health emergency. CDER has said it will work with sponsors to help them gain approval of COVID therapeutics cleared under emergency use authorizations, but agency will likely not issue a formal transition framework.
Company Information
- Industry
- Biotechnology
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Pharmaceuticals
- Drug Delivery
- Specialty Pharmaceuticals
- Other Names / Subsidiaries
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- Arresto Biosciences, Inc.
- Asegua Therapeutics, LLC
- Calistoga Pharmaceuticals, Inc.
- CGI Pharmaceuticals, Inc.
- CV Therapeutics, Inc.
- Cytopia Limited
- EpiTherapeutics
- Eximias Pharmaceutical Corporation
- Immunomedics, Inc.
- MiroBio
- Myogen
- MYR GmbH
- Nimbus Apollo, Inc.
- Nexstar Pharmaceuticals
- Oligogen, Inc.
- Pharmasset, Inc.
- Triangle Pharmaceuticals
- YM BioSciences Inc. (YMI)
- Kite Pharma, Inc.
- Kite Pharma EU
- T-Cell Factory B.V. (TCF)
- Cell Design Labs, Inc.
- Asegua Therapeutics
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