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, ...

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 FDA issued a complete response letter for the EYLEA HD prefilled syringe, delaying its approval and impacting potential sales growth. Regeneron Pharmaceuticals Inc (NASDAQ:REGN) faces ...

Last April, the FDA issued a Complete Response Letter (CRL) in response to the company’s Biologics License Application (BLA) for pz-cel for RDEB. The FDA noted that certain additional ...

Just days before that complete response letter, the FDA also rebuffed Regeneron’s bid to win extended dosing intervals for Eylea HD across all the med’s approved indications. Transitioning U.S ...

is anticipated to result in a quick growth rebound after an initial revenue decline because of a complete response letter. The company’s management gave optimistic guidance for Izervay sales in ...

The FDA issued a Complete Response Letter (CRL) for the EYLEA HD pre-filled syringe on April 23, 2025. The Company held several teleconferences with the FDA to better understand the contents of ...

The FDA delivered a blow to Spero's hopes of bringing the carbapenem to market in a complete response letter (CRL) delivered this week, which said another trial would be required to support approval.

On April 3, 2025, Aldeyra Therapeutics issued a press release stating that the FDA issued a Complete Response Letter for the NDA for reproxalap. The FDA stated that the NDA “failed to ...

The FDA target action date is August 19, 2025, following the use of a priority review voucher. The FDA issued a Complete Response Letter (CRL) for the EYLEA HD pre-filled syringe on April 23, 2025.