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Regulatory

92 Articles available
Regulatory

FDA Approves New Pfizer Biosimilar

PR-M12-17-NI-010
Regulatory

Vedanta Biosciences Granted Four New U.S. Patents Expanding Coverage for Compositions and Methods of Use for Therapeutics

PR-M12-17-NI-009
Regulatory

FDA Approves Admelog, The First Short-Acting "Follow-On" Insulin Product To Treat Diabetes

PR-M12-17-NI-008
Regulatory

Booklet Label Combines Tamper-Protection And Drug Information

PR-M12-17-NI-004
Biosimilars

Boehringer Ingelheim’s Adalimumab Biosimilar Wins First EU Approval

PAO-M11-17-NI-045
Drug Development

Small Molecule Cancer Combination Therapy Receives Second Patent

PAO-M11-17-NI-031
FDA

First Treatment for Rare Blood Disorder Approved by FDA

PAO-M11-17-NI-026
Diagnostics

Ultrasound Transducer from Butterfly Network Receives FDA Approval for 13 Applications

PAO-M11-17-NI-023
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
FDA

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
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