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Trials & Approvals FDA
Ascendis’ Hormone Drug Hits Another FDA Roadblock on Path to Approval
2023-05-02
Regulatory India
Sun Pharma Temporarily Pauses Shipments from Mohali Following FDA’s Mandate for Corrective Actions
2023-04-24
Trials & Approvals Mesoblast Limited
Mesoblast’s Resubmission Brings First-of-its-Kind Therapy One Step Closer to Approval
2023-03-09
Trials & Approvals RSV vaccines
Pfizer and GSK Neck and Neck for First FDA-Approved RSV Vaccine
2023-03-03
Trials & Approvals Arrhythmias
Abbott’s New Technologies for Arrhythmia Treatment Secure FDA and European Approval
2023-02-04
Policy FDA
Retail Pharmacies Can Dispense Abortion Pills Under New FDA Ruling
2023-01-05
Special Aduhelm
The FDA and Biogen Taking Heat for Aduhelm’s Approval Process
2022-12-30
Trials & Approvals Breast Cancer
Immutep Expands Patient Population For LAG-3 Candidate After FDA Meeting
2022-12-26
Trials & Approvals Orphan Drug Designation
Algernon Wins FDA Orphan Drug Designation For Rare Lung Disease Candidate
2022-12-07
Special Opioid
Walmart To Settle Opioid Lawsuits with $3.1 Billion, U.S. Government Mulls OTC Naloxone
2022-11-15
Trials & Approvals hepatitis B
The FDA Expands Use for Gilead Science’s HBV Treatment
2022-11-02
Trials & Approvals European Medicines Agency
Santhera, ReveraGen’s Duchenne Drug Accepted By EMA While Anticipating FDA Priority Review
2022-11-01
Trials & Approvals FDA
FDA Announces Two Product Recalls Over Concerns of Particulates and Impurities
2022-10-26
Trials & Approvals Rare Disease
Bristol Myers Squibb’ sNDA for Rare Heart Disease Treatment Accepted by the FDA
2022-10-21
Policy FDA Guidance
FDA Drops New Oncology Development Guidelines
2022-10-18
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