The FDA did not agree with a supplemental Biologics License Application for the addition of extended dosing intervals of up ...

The complete response letter (CRL) specifies that the current dosage duration of aflibercept is still safe but extending the ...

Abeona Therapeutics' pz-cel gene therapy shows the most durable wound healing in RDEB patients. See why I rate ABEO stock a ...

Following a complete response letter last year, Satsuma Pharmaceuticals Inc. received U.S. FDA approval of dihydroergotamine nasal powder to treat acute migraine with or without aura. Branded Atzumi, ...

The FDA has asked the commissioner’s office to set a hearing by mid-September 2025 for Vanda's request, which was prompted by a complete response letter (CRL). In a letter to the biotech last ...

saw the price of their shares crash over 70% after the company announced that it received a Complete Response Letter (“CRL”) from the FDA for the resubmission of the New Drug Application ...

Barely a year after the U.S. FDA shackled Abeona Therapeutics Inc.’s cell-based gene therapy with a complete response letter, the agency has approved it for treating a rare and genetic skin disease.

The complete response letter did not identify any issues with the safety or efficacy of Eylea HD, Regeneron officials said.

Please check back soon for updates. The FDA issued a complete response letter for a supplemental biologics license application, in which it did not approve extending the dosing intervals for Eylea ...

Aldeyra Therapeutics' stock plummeted 74% due to an FDA Complete Response Letter for reproxalap but presents a favorable risk-reward for speculative investors. Despite past setbacks, ALDX's ...