Pretomanid in combination with bedaquiline and linezolid has been approved by the FDA for treatment-resistant tuberculosis of the lungs.
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In order keep up-to-date records and protect public health the FDA has announced it intends to deactivate out-of-date drug listings.
An open letter has underscored the challenges of return failure in the US drug supply chain, especially after the introduction of the Drug Supply Chain Security Act in November.
Lidocaine topical cream and liquid gel products are being recalled as the lidocaine amount is higher than the label states.
The pharmaceutical company failed to inform the FDA of manipulated data when the gene therapy was under review and could face a legal battle.
The Philippines is considering re-introducing a dengue vaccine whose use was ceased because of links to several deaths.
The EMA has requested that liposomal medication names be changed to avoid the risk of confusion.
The pharmaceutical industry is set to face some major changes in the near future, to improve the quality of returned drugs and medications.
EMA’s human medicines committee had cleared the cannabidiol oral solution, Epidiolex, for use to treat seizures.
Two lots of Kogenate® FS vials actually contain the FVIII hemophilia A treatment, Jivi®.
The FDA has released draft guidance for using the Inactive Ingredients Database to aid drug developers.
A pharmaceutical manufacturing site in New Jersey receives FDA warning letter for failing to thoroughly investigate quality problems and data integrity issues.
Three API re-packers who failed to meet current good manufacturing practice requirements have received warning letters from the FDA.