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FDA approves Analog and Dipharma’s ANDA for nitisinone capsules

Pharmaceutical Technology

The US Food and Drug Administration (FDA) has granted clearance to Analog Pharma and Dipharma’s abbreviated new drug application (ANDA) for 20mg nitisinone capsules. Some of the most common side effects of nitisinone include low platelet count, elevated tyrosine levels, eye pain, white or cloudy cornea from scarring, and pink eye.

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Why There's No Such Thing as a 'Safe' Drug?

Contrarian Sales Techniques

This includes potential side effects or adverse reactions to medications. The results of these studies are carefully analyzed and scrutinized by regulatory bodies, such as the FDA in the United States. This is before a drug can be approved for public use.

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Developing point-of-care CAR T manufacturing

European Pharmaceutical Review

Second, the production and delivery of CAR T cells necessitates close collaboration between the pharma industry and academic (usually transplant) departments. After this incident CAR-related toxicity scales and guidelines were established to prevent adverse reactions. 6-8 Clinical recommendations also change.