The U.S. Food and Drug Administration has published more than 200 complete response letters, or decision letters, sent as ...

The FDA has accepted the New Drug Application for ET-600, an oral solution formulation of desmopressin, for the treatment of central diabetes insipidus.

The inspection concluded with a Form 483 containing several observations. Capricor said it has submitted its responses to the FDA, none of which required material changes to the cGMP process or ...

Capricor Therapeutics' rating was downgraded amid FDA inspection risks, regulatory uncertainty, and potential delays in approval for deramiocel. Read more on CAPR stock here.

Incyte Announces FDA Approval of Zynyz® (retifanlimab-dlwr) Making it the First and Only Approved First-Line Treatment for Advanced Anal Cancer Patients in the United States ...

"The FDA approval of Zynyz marks a pivotal moment, bringing effective combination and monotherapy treatment options to patients with advanced anal cancer after decades of limited innovation," said ...

A top agency official is meeting with industry and FDA staff as he works on guidance clarifying the FDA’s expectations for vaccines.

One lot of Systane Lubricant Eye Drops Ultra PF, manufactured by Alcon Laboratories, has been recalled due to fungal contamination, the FDA announced this week.

FDA Form 1572. ASCO emphasized the need for further clarification and definition on FDA Form 1572 and the role of clinical investigators and sub-investigators. ASCO also shared that the form ...

The statement was published in the Journal of Clinical Oncology and includes 1 recommendation specifically for the FDA, along with 3 others for the broader research community. The task force ...

In January 2024, an ASCO-led, multistakeholder group published a call to action to advance patient-focused DCTs. 20 It identified FDA's Statement of Investigator Form (Form 1572) as a key barrier, ...