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 ...

Milestone Pharmaceuticals MIST recently announced that the FDA has issued a Complete Response Letter (“CRL”) for its New Drug Application (“NDA”) seeking approval for CARDAMYST (etripamil ...

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 ...

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

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.

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 ...

You can see the complete list of today’s Zacks #1 Rank stocks here. Masimo’s shares have gained 1.4% against the industry’s 4.5% decline so far this year.