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

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

In November 2023, the FDA issued a Complete Response Letter to the initial NDA stating that at least one additional symptom trial was required. Following discussions with the FDA, and as part of 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, ...

Aldeyra Therapeutics shares fell 73% to $1.42 in the regular session after it reported a Food and Drug Administration complete response letter for reproxalap for treatment of dry eye disease.

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 ...

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 ...

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 ...

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.