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New FDA Regulations in the Year 2024 Muhammad Asim Niazi
January 07, 2025
The United States FDA regulates pharma drug products manufactured or marketed in the United States. There are many different functions of the FDA, and one of them is devising new regulations.
What are the FDA guidelines for contract packaging Muhammad Asim Niazi
October 18, 2024
More and more pharmaceutical product manufacturers are considering contract packaging, specifically those who can’t afford to develop a manufacturing site or are tackling higher production requirements.
Thrombolytic Science Announces FDA’s IND Clearance of Mutant Prourokinase for the Treatment of Thrombotic Diseases PharmaSources
October 15, 2024
Thrombolytic Science, LLC (TSI), announced today that the U.S. Food and Drug Administration (FDA) has cleared its Investigational New Drug (IND) application for mutant prourokinase, a recombinant fibrinolytic pro-enzyme.
InnoCare Announces Clearance of Clinical Trial of TYK2 Inhibitor ICP-332 by U.S. FDA PharmaSources
June 11, 2024
InnoCare Pharma (HKEX: 09969; SSE: 688428), a leading biopharmaceutical company focusing on the treatment of cancer and autoimmune diseases, announced today that the U.S. Food and Drug Administration (FDA) has cleared the Investigational New Drug (IND) ap
Amidst contentious debates, what path will the FDA take with accelerated approvals? Krebs Qin
May 06, 2024
Accelerated approval is a privilege that every applicant desires.
The Narrative of Pharmaceuticals Bestowed with Endorsement and Later Reclaimed by Oblivion by the FDA zhulikou431
March 06, 2024
This document endeavors to compile and elucidate data pertaining to instances where the U.S. FDA, in recent years, has rescinded market approval for pharmaceuticals previously sanctioned.
Johnson & Johnson’s Balversa therapy finally gets full FDA approval Shem Oirere
March 05, 2024
The approval by the Federal Drug Agency of the bladder cancer therapy Balversa has taken a notch higher the search for more treatment options.
Brief Summary of FDA Quality Management Maturity Program Muhammad Asim Niazi
March 05, 2024
United States FDA has a pivotal role in providing guidance for pharmaceutical quality attributes and defining new ways to improve the quality by publishing new regulations for quality enhancement.
InnoCare Announces Clearance of Clinical Trial of BCL2 Inhibitor ICP-248 by U.S. FDA PharmaSources
January 16, 2024
ICP-248 is a novel, orally bioavailable BCL2-selective inhibitor, which aims to treat hematologic malignancies as a monotherapy or in combination with other therapies.
Case study of FDA warning letters Muhammad Asim Niazi
January 23, 2024
A warning letter is a part of communication by the FDA with the manufacturer to share their finding to remove the discrepancy found during their inspection and inform the status of the manufacturer's measures.