By publishing more than 200 complete response letters, the FDA is offering new visibility into the issues that most often ...

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When the FDA unexpectedly uploaded around 200 drug rejection letters this week, the regulator provided a rare glimpse in | ...

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The US FDA has published more than 200 complete response letters sent as replies to drug and biological product applications.

The company said it was “surprised” by the decision, which followed the ouster of multiple cell and gene therapy officials from the agency during deramiocel’s review.

The FDA published a database of letters sent to drugmakers during the review process of medications that provide information on the agency's initial feedback or requirements for more data. These ...

In its complete response letter, the FDA cited insufficient evidence establish deramiocel's effectiveness for cardiomyopathy ...

Milestone Pharmaceuticals (MIST) stock falls amid a capital raise as FDA agrees to review its resubmitted NDA for heart therapy Cardamyst. Read more here.

A journey through the FDA’s newly released complete response letters gave glimpses into the journeys to market for Eli ...

A new EastEnders guest star has revealed she was previously rejected by the soap 37 years ago. Shazia Mirza appears in today's episode of the BBC soap as Dr Ayub, who is involved in the baby Jimmy ...

The letters, many of which were already available online, detail why the regulators initially declined to approve some drugs.