Saturday, March 2, 2024

CATEGORY

Healthcare Policy and Regulation

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...

Alabama Supreme Court Decision on Frozen Embryos Stirs Anxiety Among Cancer Patients and Professionals

The recent decision by the Alabama Supreme Court to legally classify frozen embryos as children has triggered broad concern among cancer patients and medical...

Key Update on the Pricing of Pharmaceutical Products and Its Impacts in Turkiye

A recent regulation amendment has significantly changed the Decree on the Pricing of Pharmaceutical Products. This change concerns the fixed exchange rate of the...

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...

Potential Price Cap in State-Level Drug Pricing Strategies by Enbrel Signals Shift

Colorado's prescription drug affordability board's move marks a potential precedent in state-led initiatives to confront high drug pricing, exploring the possibility of capping the...

Ensysce Nears Milestone in Opioid Medication Safety with Promising FDA Discussions on PF614-MPAR

Ensysce Biosciences, a leading innovator in the field of clinical-stage pharmaceutical development, has announced significant progress following a constructive meeting with the Food and...

Artiva’s Lupus Nephritis Treatment AlloNK Gets FDA New Drug Application Approval

Artiva has received FDA clearance for their investigational new drug application for lupus nephritis treatment AlloNK plus rituximab, marking the first IND clearance for...

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...

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