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Media Kit
FDA Approval (5)
284 Articles Available
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FDA Approval
FDA Approves First Treatment for Postpartum Depression
PR-M03-19-NI-064
FDA Approval
Allergan Announces FDA Approval of AVYCAZ® (ceftazidime and avibactam) for Pediatric Patients
PR-M03-19-NI-054
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 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
Diabetes
FDA Authorizes First Interoperable Insulin Pump Intended to Allow Patients to Customize Treatment Through Their Individual Diabetes Management Devices
PR-M02-19-NI-044
FDA
FDA Advisory Committee Recommends Approval of SPRAVATO™ (esketamine) Nasal Spray CIII for Adults with Treatment-Resistant Depression
PR-M02-19-NI-030
FDA Approval
U.S. FDA Approves DARZALEX® (daratumumab) Split-Dosing Regimen
PR-M02-19-NI-028
FDA Approval
Grifols Receives FDA Approval for Procleix Babesia Assay for Donor Screening on Procleix Panther System
PR-M02-19-NI-017
FDA Approval
U.S. FDA Approves Botox Competitor
PAO-M02-19-NI-005
FDA Approval
Mylan Announces FDA Approval of Wixela™ Inhub™, First Generic of ADVAIR DISKUS®
PR-M02-19-NI-005
FDA Approval
I-Mab Receives IND Approval from the US FDA to Initiate Clinical Trials for Its Proprietary TJC4, a Potential Global Best-in-Class Anti-CD47 Monoclonal Antibody
PR-M01-19-NI-082
FDA Approval
FDA Approves Use of 0.5 mL Dose of Fluzone® Quadrivalent (influenza vaccine) in Children as Young as 6 Months of Age
PR-M01-19-NI-070
FDA
Acurx Receives FDA Fast Track Designation for ACX-362E for the Treatment of C. difficile infection
PR-M01-19-NI-060
FDA Approval
FDA Approves First Generic Version of Sabril to Help Treat Seizures in Adults and Pediatric Patients with Epilepsy
PR-M01-19-NI-057
FDA
FDA Approves World's First Device for Treatment of Premature Babies and Newborns with an Opening in Their Hearts (a Common Congenital Defect)
PR-M01-19-NI-048
Inhalation
FDA Approves First Inhaler with Built-in Sensors
PAO-M01-19-NI-009
FDA Approval
FDA Approves Parkinson’s Drug
PAO-M01-19-NI-002
FDA Approval
FDA Approves Roche's Tecentriq in Combination with Avastin and Chemotherapy for the Initial Treatment of People with a Specific Type of Metastatic Lung Cancer
PR-M12-18-NI-041
Approval
Genentech Receives Additional Approval for Tecentriq
PAO-M12-18-NI-011
FDA Approval
FDA Approves First Biosimilar for Treatment of Adult Patients with Non-Hodgkin's Lymphoma
PR-M12-18-NI-004
FDA Approval
FDA Approves an Oncology Drug that Targets a Key Genetic Driver of Cancer, Rather than a Specific Type of Tumor
PR-M11-18-NI-105
FDA Approval
FDA Approves Vitrakvi® (larotrectinib), the First Ever TRK Inhibitor, for Patients with Advanced Solid Tumors Harboring an NTRK Gene Fusion(1,2)
PR-M11-18-NI-104
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