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FDA Approval
Sun Pharma Announces U.S. FDA Approval of CEQUA™ to Treat Dry Eye Disease
PR-M09-18-NI-053
Study Results
Teva and Regeneron Announce Positive Topline Phase 3 Fasinumab Results in Patients with Chronic Pain from Osteoarthritis of the Knee or Hip
PR-M09-18-NI-051
Approval
Trovagene Receives USAN Approval for "Onvansertib" as Nonproprietary Name for First-in-Class, 3rd Generation PLK1 Inhibitor Drug Candidate, PCM-075
PR-M09-18-NI-048
Oncology
GeneNews and LifeX™ Partner to Deliver Proprietary "Liquid Biopsy" Molecular Diagnostics to Health Systems to Detect Cancer at Earliest Stages
PR-M09-18-NI-047
Study Results
Janssen Reports Positive Topline Results for ATLAS Phase III Study of a Novel, Long Acting Injectable Two-Drug Regimen for the Treatment of HIV-1
PR-M09-18-NI-045
Drug Designation
Martin Pharmaceuticals’ LIVANTRA™ Receives FDA Orphan Drug Designation in Second Indication
PR-M09-18-NI-033
Orphan Drug Designation
FDA Grants Orphan Drug Designation to Onspira Therapeutics' Investigational Interleukin-1 Receptor Antagonist for the Treatment of Bronchiolitis Obliterans
PR-M09-18-NI-032
Injectables
Kaléo Confirms U.S. Availability of AUVI-Q® (epinephrine injection, USP) Auto-injector for Back-to-School Season
PR-M09-18-NI-023
Generics
Mylan Launches First Generic for Adcirca® Tablets
PR-M09-18-NI-021
FDA Approval
Medicure Announces FDA Approval of Acute Care Cardiovascular Drug Sodium Nitroprusside Injection
PR-M09-18-NI-020
Oncology
New Analysis Identifies Patient Populations With Cancer-associated VTE Who Could Benefit From Treatment With Oral, Once-daily LIXIANA®▼ (edoxaban)
PR-M09-18-NI-018
Regulatory
Regeneron Provides Regulatory Update on EYLEA® (aflibercept) Injection sBLA in Wet Age-Related Macular Degeneration
PR-M09-18-NI-016
Workforce
Grant Will Fund Workforce Development Program for Biopharma Industry
PAO-M09-18-NI-001
Logistics
LATAM Cargo Opens Pharma Hub in Denmark
PR-M09-18-NI-073
FDA Approval
FDA Grants Breakthrough Therapy Designation for Xolair(Omalizumab) for Food Allergies
PR-M09-18-NI-005
FDA Approval
TherapeuticsMD Announces FDA Approval of ANNOVERA™ (Segesterone Acetate/Ethinyl Estradiol Vaginal System) for Birth Control
PR-M09-18-NI-002
Clinical Data
Novartis Reports Promising Results for its New Alpha Specific PI3K Inhibitor BYL719
PAO-M08-18-NI-028
FDA Approval
Sesen Bio Announces Vicinium Granted Fast Track Designation by FDA for Treatment of Non-Muscle Invasive Bladder Cancer
PR-M08-18-NI-099
Regulatory
China to Accelerate Review of 48 Foreign Drugs
PAO-M08-18-NI-013
China
Big Pharma Companies Taking New Drugs to China First
PAO-M08-18-NI-010
Industry Trend
China Turning to Indian Drug Manufacturers in Response to Trade War with US
PAO-M07-18-NI-011
Legislation
“Right To Try” Now Legal Across State Lines
PAO-M05-18-NI-026
Controlled Nucleation
Achieving Controlled Nucleation During Aseptic Lyophilization
PAP-Q2-18-CL-018
Market Expansion
BioPharma CDMO Success Requires Technical Leadership and Problem-Solving Capabilities
PAP-Q2-18-CL-019
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