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Regulatory
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FDA
FDA, European Regulators Align for More Efficient GMP Inspections
PAO-M11-17-NI-002
FDA Approval
Calquence, AstraZeneca’s BTK Inhibitor Approved by FDA
PAO-M11-17-NI-001
Regulatory
No Clinically Meaningful Difference: The Upward Trend of Biosimilars
PAP-Q4-17-FA-001
CAR-T
Breakthrough CAR-T Immunotherapy Approved
PAO-M10-17-NI-037
Drug Pricing
California Moves to Increase Transparency of Prescription Drug Pricing
PAO-M10-17-NI-030
FDA Approval
FDA Expands 510(k) Clearance for NuVasive’s Limb Lengthening Platform to Include Bone Transport
PAO-M10-17-NI-022
FDA Approval
FDA Approves New, Implantable Sleep Apnea Treatment
PAO-M10-17-NI-016
FDA
FDA Grants Priority Review to Gilotrif® For Uncommon EGFR Mutations in Advanced NSCLC
PR-M10-17-NI-002
FDA Approval
Novartis Receives First Ever FDA Approval For A CAR-T Cell Therapy, Kymriah(TM) (CTL019)
PR-M08-17-NI-010
FDA
FDA Finalizes Emerging Drug Manufacturing Technology Guidance
PAO-M10-17-NI-012
Innovation
New Plant Will Supply Large Numbers of Genetically Modified Mosquitos
PAO-M10-17-NI-008
FDA Approval
Eli Lilly Gets Early Approval for Breast Cancer Drug
PAO-M10-17-NI-006
FDA Approval
FDA Approves Grifols’ Prolastin-C Liquid
PAO-M09-17-NI-032
Biosimilar
FDA Approves First Biosimilar Treatment for Multiple Cancers
PAO-M09-17-NI-030
GSK Shingles Vaccine Recommended for Approval by FDA Panel
PAO-M09-17-NI-027
Serialization
PCI Pharma Services Announces Release of Joint White Paper with Domino on Ink Leachability in Pharmaceutical Serialization
PR-M09-17-NI-008
Innovation
FDA Green Lights Mobile App to Help Treat Drug Abuse
PAO-M09-17-NI-022
ADC
Pfizer Gets Second ADC Approval in 2017
PAO-M09-17-NI-019
Innovation
Women Gain New Control Over Mammogram Discomfort
PAO-M09-17-NI-016
FDA
Collaborations within FDA Intended to Improve Facility Inspections and Facilitate Drug Approvals
PAO-M09-17-NI-010
FDA
FDA’s Gottlieb Weighs in on the Drug Quality and Security Act (DQSA)
PAO-M06-17-NI-018
Regulatory
Implications of Serialization for the U.S. Pharma Industry
PAP-Q2-17-CL-001
Regulation
Serialization: The First Steps In Sales Unit Traceability and Data Management
PAP-Q2-17-CL-002
CDMO
Supporting the Tech Transfer Continuum for Cell & Gene Therapies
PAP-Q2-17-CL-003
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