FDA “complete response” letter seeks another trial to better define the most tolerable dose, which could get the atypical antipsychotic to market in a better position than the original dataset.
The additional clinical trial requested by FDA to support approval of Forest Laboratory Inc./Gedeon Richter Ltd.’s antipsychotic cariprazine could make the product more competitive if it does reach the market.
A dopamine D2/D3 receptor agonist, the firms are seeking approval for treatment of schizophrenia and acute treatment of manic or...
Advanz Pharma would have had to show that the European Commission’s decision to revoke Ocaliva’s conditional marketing approval risked causing serious and irreparable harm, according to lawyers from Van Bael & Bellis.
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A new pilot aims to take Brazil closer to ‘digital transformation.’
The UK drug regulator has introduced several changes in recent months, such as the introduction of a decentralized manufacturing regulation. Matthew Durdy, CEO of the Cell and Gene Therapy Catapult, explains what these changes mean for the cell and gene industry.
The European Medicines Agency’s inaugural bilateral meeting with the Association of Clinical Research Organizations underscores ACRO’s commitment to advancing innovation and its presence in the EU clinical trials ecosystem.
The Medicines Control Authority of Zimbabwe has begun phasing in mandatory package labeling requirements based on GS1 identification standards. It aims to improve the traceability of medicines throughout the entire supply chain.
