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Food and Drug Administration (FDA)

NEWS
Drug Development
Biopharma Update on the Novel Coronavirus: June 26
Please check out the biopharma industry coronavirus (COVID-19) stories that are trending for June 26, 2020.
June 25, 2020
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3 min read
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BioSpace Editorial Staff
Drug Development
Biopharma Update on the Novel Coronavirus: June 24
Please check out the biopharma industry coronavirus (COVID-19) stories that are trending for June 24, 2020.
June 23, 2020
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4 min read
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BioSpace Editorial Staff
Drug Development
Biopharma Update on the Novel Coronavirus: June 22
Please check out the biopharma industry coronavirus (COVID-19) stories that are trending for June 22, 2020.
June 22, 2020
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3 min read
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BioSpace Editorial Staff
Policy
FDA Action Alert: Karyopharm, Zogenix, Chiasma, Heron, Intercept and Merck
Wrapping up June and ahead of the July 4 holiday, the U.S. Food and Drug Administration (FDA) has a busy two-week period coming up for drug approvals. Here’s a look.
June 19, 2020
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3 min read
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Mark Terry
FDA
FDA Approves Bone-Softening Disorder Treatment Crysvita
Crysvita is a drug developed by Ultragenyx Pharmaceutical and Tokyo-based Kyowa Kirin Co. Ltd., a specialty pharmaceutical company.
June 19, 2020
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2 min read
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Alex Keown
FDA has finally approved tavneos for ANCA Vasculit
FDA
Epizyme’s Tazverik Picks Up Its Second FDA Approval of 2020
The FDA approved a supplemental New Drug Application for Tazverik (tazemetostat) for the treatment of two distinct follicular lymphoma (FL) indications.
June 19, 2020
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2 min read
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Alex Keown
Drug Development
Biopharma Update on the Novel Coronavirus: June 19
Please check out the biopharma industry coronavirus (COVID-19) stories that are trending for June 19, 2020.
June 18, 2020
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4 min read
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BioSpace Editorial Staff
FDA
FDA Approves Second Biomarker-Specific Indication for Merck’s Keytruda
This is the second such biomarker-specific approval for Keytruda. The first biomarker-specific approval came in 2017.
June 17, 2020
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2 min read
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Alex Keown
Uplizna got green signal from FDA
FDA
FDA Greenlights Two Novartis Drugs, Including First for Adult-Onset Still’s Disease
Novartis is the first company to the finish line with an approved treatment for Adult-Onset Still’s Disease (AOSD), a rare autoinflammatory disease of unknown origin.
June 17, 2020
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2 min read
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Alex Keown
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JOBS
IN THE PRESS
Policy
Citius Pharmaceuticals, Inc. Receives a Complete Response Letter from the U.S. Food and Drug Administration (FDA) for LYMPHIR™ (Denileukin Diftitox) for the Treatment of Patients with Relapsed or Refractory Cutaneous T-Cell Lymphoma
July 29, 2023
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6 min read
Policy
FDA Roundup: July 28, 2023
July 28, 2023
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2 min read
Latest Updates of 7 Viva’s Portfolio Companies
July 28, 2023
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11 min read
Business
Committee to Restore Nymox Shareholder Value Challenges Nymox CEO Averback to Publish 2022 FDA Refusal To File Correspondence Received May 10, 2022
July 27, 2023
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2 min read
FDA
FDA Grants Breakthrough Therapy Designation to NS-089/NCNP-02 for the Treatment of Duchenne Muscular Dystrophy
July 27, 2023
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2 min read
FDA
FDA Grants Clearance for UltraSight’s AI-Powered Cardiac Ultrasound Technology
July 27, 2023
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4 min read
FDA
Cosette Pharmaceuticals Launches Metronidazole Vaginal Gel 0.75%, AB-rated to MetroGel-Vaginal® 0.75%
July 27, 2023
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2 min read
FDA
Cessation Therapeutics Announces Food and Drug Administration Authorization for First-in-Human Clinical Trial of Antibody for Prevention of Fentanyl Overdose
July 27, 2023
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5 min read
FDA
MyoPax Receives FDA Orphan Drug Designation for its Innovative Regenerative Cell Therapy for Exstrophy-Epispadias Complex
July 26, 2023
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3 min read
Business
LianBio Partner Tarsus Pharmaceuticals Announces U.S. FDA Approval of XDEMVY™ (lotilaner ophthalmic solution) 0.25% for the Treatment of Demodex Blepharitis
July 26, 2023
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5 min read
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