Saturday, March 2, 2024

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Zahra Ahangar Atashi

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Bayer’s Lung Cancer Treatment Earns FDA Breakthrough Therapy Designation

Bayer's innovative small molecule tyrosine kinase inhibitor (TKI) BAY 2927088 has received Breakthrough Therapy designation from the FDA for the treatment of unresectable or...

Expanding Horizons in Multiple Myeloma Treatment: CHMP Backs Earlier Application of Carvykti CAR-T Therapy

European drug regulators have given their endorsement for Johnson & Johnson (J&J) and Legend Biotech’s Carvykti to be used earlier in the multiple myeloma...

Simlandi’s Approval Revolutionizes Biosimilar Landscape: A Game-Changer for Humira’s Dominance

Pharmacists in the United States are now granted the authority to substitute a more affordable biosimilar version for AbbVie's high-concentration formulation of Humira without...

SeaStar’s Device Receives Humanitarian Device Exemption Status to Aid Children with AKI

In the wake of encouraging clinical results, SeaStar Medical, a pioneering entity in the medical device industry, has garnered approval from the prestigious US...

OCR’s Annual Reports to Congress Highlight Health Insurance Compliance Efforts and Cybersecurity Trends

The U.S. Department of Health & Human Services Office for Civil Rights (OCR) issued its annual Reports to Congress regarding Health Insurance Portability and...

FDA Priority Review for Breakthrough Biologic Therapy: Dupixent Eyes New Frontier in COPD Treatment

Regeneron Pharmaceuticals and Sanofi have announced that the U.S. Food and Drug Administration (FDA) has accepted for Priority Review the supplemental Biologics License Application...

FDA Warns Medical Device Companies Against Unreliable Third-Party Lab Data in Submissions

The FDA has issued a statement urging medical device companies to carefully assess the reliability of third-party testing data before submitting it to the...

Legal Clash Over Pharmaceutical Application: United Therapeutics Sues FDA Over Rival Liquidia’s Approval

In a rare legal maneuver, United Therapeutics has initiated legal action against the FDA, alleging that the regulatory body deviates from established protocols by...

FDA Accelerates Approval of Tumor-Infiltrating Lymphocytes Therapy Amtagvi for Solid Tumors

Iovance Biotherapeutics recently achieved a significant milestone with the FDA granting accelerated approval for their groundbreaking tumor-infiltrating lymphocytes (TIL) therapy designed to combat solid...

FDA Grants Breakthrough Device Status to Better Therapeutics’ Digital Therapy for Liver Disease

Better Therapeutics has achieved a breakthrough device status from the FDA for its digital therapeutic aimed at treating adults with advanced liver disease, marking...

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