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FDA
263 Articles Available
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11
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FDA Approval
FDA Approves New Device for Treating Moderate to Severe Chronic Heart Failure in Patients
PR-M03-19-NI-068
FDA Approval
FDA Approves First Treatment for Postpartum Depression
PR-M03-19-NI-064
FDA
Medical Implants to Receive FDA Review
PAO-M03-19-NI-028
FDA
FDA Gets New Acting Head
PAO-M03-19-NI-028
FDA
FDA Announces Modernization Strategies for Clinical Trials of Precision Medicines
PAO-M03-19-NI-025
FDA Approval
Allergan Announces FDA Approval of AVYCAZ® (ceftazidime and avibactam) for Pediatric Patients
PR-M03-19-NI-054
Investment
Successful Funding Round Could Lead to Commercialization of Bio-integrative Bone Pin
PAO-M03-19-NI-023
Priority Review
FDA Grants Priority Review to Dupixent for Treatment of Adults with Severe Chronic Rhinosinusitis
PAO-M03-19-NI-017
Regulatory Spotlight
Understanding the FDA’s Approach to Real-World Evidence
PAP-Q1-2019-NI-008
Biosimilars
Statement from FDA Commissioner on Naming of Biological Medicines to Balance Competition and Safety for Patients Receiving These Products
PR-M03-19-NI-030
Innovation
FDA Releases Final Classification for Natural Cycles, the First and Only Birth Control App in the U.S.
PR-M03-19-NI-031
FDA Approval
FDA Approves New Nasal Spray Medication for Treatment-resistant Depression; Available Only at a Certified Doctor's Office or Clinic
PR-M03-19-NI-027
FDA
Lilly Receives FDA Priority Review Designation for Emgality® (galcanezumab-gnlm) Injection for the Preventive Treatment of Episodic Cluster Headache in Adults
PR-M03-19-NI-017
FDA Approval
NKMax America Announces FDA Approval of IND for Phase 1 Trial of SNK01 in Patients with Refractory Cancer
PR-M03-19-NI-018
FDA
New Form of Herceptin Approved by U.S. FDA for Breast Cancer
PAO-M03-19-NI-010
Orphan Drug
Cholangiocarcinoma Drug Receives Orphan Drug Designation from FDA
PAO-M03-19-NI-003
Pediatric
Novo Nordisk Files for a Label Update for Fiasp® to the EMA and the FDA Seeking Approval for Use in Children and Adolescents
PR-M03-19-NI-007
Drug Recall
FDA Provides Update on its Ongoing Investigation into ARB Drug Products and Losartan Product Recall
PR-M03-19-NI-001
Postmarketing Trial
FDA Responds to Safety Signal Reported in Required Postmarketing Trial for Xeljanz
PR-M02-19-NI-068
Public Health
FDA, CDC, and CMS Launch Task Force to Help Facilitate Rapid Availability of Diagnostic Tests During Public Health Emergencies
PR-M02-19-NI-062
FDA Statement
Statement on the FDA's Modern Approach to Advanced Pharmaceutical Manufacturing
PR-M02-19-NI-064
Opioids
Statement from FDA Commissioner Scott Gottlieb, M.D. on the Agency's 2019 policy and Regulatory Agenda for Continued Action to Forcefully Address Opioid Abuse
PR-M02-19-NI-061
FDA
FDA Warns about Claims of Aging and Memory Loss Prevention with Infusions of Young Donor Plasma
PAO-M02-19-NI-021
Accelerated Approval
Merck’s Keytruda to Get Accelerated FDA Evaluation for Treatment of Head and Neck Cancer
PAO-M02-19-NI-015
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