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March 23, 2023
The recent document will guide the use of DHT-derived data in regulatory decision-making for drugs and biological products.
March 16, 2023
27 drugs within Medicare will face penalties for having their prices raised faster than the rate of inflation.
March 14, 2023
FDA is seeking $7.2 billion to enhance food safety and advance medical product availability.
March 10, 2023
Even after an FDA advisory panel voted 14–1 in October 2022 to remove the drug, Makena manufacturer Covis Pharma continued to press for some continued access to the therapy.
March 09, 2023
Congressional leaders are investigating how pharmacy benefit managers determine health plan coverage and charges for medicines.
March 08, 2023
Janssen has received a positive opinion from EMA for AKEEGA plus prednisone or prednisolone for the treatment of BRCA1/2 gene-mutated metastatic castration resistant prostate cancer.
March 06, 2023
Any patients who have received the identified lots or have any questions regarding the recall should contact their pharmacy or immediately contact a health provider in terms of medical advice.
The guidance is intended to build on the existing International Council for Harmonisation (ICH) quality guidance.
March 03, 2023
The new guidance provides detailed recommendations to drug developers with a target of helping to ensure that drug developers provide adequate information to assess potency at each stage of a product’s life cycle.
March 02, 2023
Advances in vaccine development are creating partnerships and stimulating clinical trials to develop new mRNA applications.