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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
Catalent is expanding its UpTempo AAV platform to accelerate the development of gene therapies.
Vetter has become a participant of the UN Global Compact Network.
Congressional leaders are investigating how pharmacy benefit managers determine health plan coverage and charges for medicines.
March 08, 2023
Actylis new 30,000-ft² API manufacturing facility is located in Eugene, Ore.
Sotatercept, a drug candidate acquired by Merck in an $11.5 billion acquisition, showed statistically significant improvements in various measures.
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.