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Food and Drug Administration (FDA)

NEWS
Drug Development
Biopharma Update on the Novel Coronavirus: April 27
Please check out the biopharma industry coronavirus (COVID-19) stories that are trending for April 27, 2020.
April 27, 2020
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7 min read
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BioSpace Editorial Staff
FDA
FDA Approves Sanofi’s Meningococcal Meningitis Vaccine
David Loew, head of Sanofi Pasteur, said U.S. approval of the vaccine is an important milestone in the fight against meningococcal meningitis, a serious global health challenge that can be fatal within 24 hours.
April 24, 2020
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2 min read
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Alex Keown
Drug Development
Biopharma Update on the Novel Coronavirus: April 24
Please check out the biopharma industry coronavirus (COVID-19) stories that are trending for April 24, 2020.
April 24, 2020
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7 min read
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BioSpace Editorial Staff
Drug Development
Biopharma Update on the Novel Coronavirus: April 23
Please check out the biopharma industry coronavirus (COVID-19) stories that are trending for April 23, 2020.
April 23, 2020
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5 min read
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BioSpace Editorial Staff
Chronic lymphocytic leukemia
FDA
Imbruvica-Rituximab Combo Approved by FDA for Chronic Lymphocytic Leukemia
The FDA recently approved the combination of Imbruvica-Rituximab for treating chronic lymphocytic leukemia. Here’s everything you need to know.
April 22, 2020
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2 min read
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Mark Terry
Drug Development
Futura files for Further Pre-Submission meeting with the FDA following receipt of its Phase 3 clinical study report
Futura Medical plc, a pharmaceutical company developing a portfolio of innovative products based on its proprietary, transdermal DermaSys® technology and currently focused on sexual health and pain, is pleased to announce that it has now filed for a further pre-submission meeting with the US FDA following receipt of the complete and signed clinical study report for its Phase 3 Study.
April 22, 2020
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3 min read
Policy
Biopharma Update on the Novel Coronavirus: April 20
Please check out the biopharma industry coronavirus (COVID-19) stories that are trending for April 20, 2020.
April 20, 2020
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4 min read
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BioSpace Editorial Staff
FDA
FDA Approves Incyte’s Pemazyre for Rare Bile Duct Cancer
The U.S. Food and Drug Administration (FDA) approved Incyte’s Pemazyre (pemigatinib) for adults with previously treated, unresectable locally advanced or metastatic cholangiocarcinoma with a fibroblast growth factor receptor 2 (FGFR2) fusion or other rearrangement.
April 20, 2020
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3 min read
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Mark Terry
TARPEYO is the first FDA-approved drug for immunog
FDA
Seattle Genetics’ Tukysa Earns FDA Approval for HER2+ Breast Cancer
Tukysa came out of Project Orbis, a multinational partnership between the FDA, the Australian Therapeutic Goods Administration, Health Canada, Health Sciences Authority and Swissmedic.
April 20, 2020
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3 min read
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Mark Terry
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JOBS
IN THE PRESS
Policy
FDA Provides Update on Proposal for Unified Human Foods Program, including New Model for the Office of Regulatory Affairs
June 27, 2023
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6 min read
FDA
FDA Approves BriaCell’s Pivotal Registrational Study Design in Advanced Metastatic Breast Cancer
June 27, 2023
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4 min read
FDA
UCB announces U.S. FDA approval of RYSTIGGO® (rozanolixizumab-noli) for the treatment of adults with generalized myasthenia gravis
June 27, 2023
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17 min read
FDA
Alcyone Therapeutics Receives FDA IDE Approval to Initiate Clinical Study of the ThecaFlex DRxTM System for Administration of SPINRAZA® (nusinersen)
June 27, 2023
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7 min read
FDA
AC Immune Receives FDA Fast Track Designation for Anti-Amyloid-beta Active Immunotherapy, ACI-24.060, to Treat Alzheimer’s Disease
June 27, 2023
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8 min read
Policy
FDA Accepts Pfizer’s Application for Hemophilia B Gene Therapy Fidanacogene Elaparvovec
June 27, 2023
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9 min read
Policy
Allecra Therapeutics Submits New Drug Application to the U.S. FDA for EXBLIFEP® for the Treatment of Complicated Urinary Tract Infections
June 27, 2023
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3 min read
Policy
Verona Pharma Submits New Drug Application to US FDA for Ensifentrine for the Maintenance Treatment of COPD
June 27, 2023
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6 min read
FDA
Femasys Announces FDA Approval of its IDE for the Pivotal Clinical Trial of FemBloc Permanent Birth Control, a Non-Surgical Alternative for Women
June 26, 2023
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5 min read
FDA
Benitec Biopharma Receives FDA Clearance of the IND for BB-301 for the Treatment of Oculopharyngeal Muscular Dystrophy
June 26, 2023
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5 min read
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