New Drug Application FDA

FDA Refuses To Review Moderna’s Flu Vaccine

FDA refuses Moderna's application for new mRNA flu vaccine, company says

Moderna received what’s called a “refusal-to-file” letter from the FDA that objected to how the company conducted a 40,000-person clinical trial comparing its new vaccine to one of the standard flu shots used today.

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FDA refuses to review Moderna flu shot in surprise setback

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FDA declines to review Moderna’s new flu vaccine

Biofrontera Announces FDA Filing Acceptance of Supplemental New Drug Application for Ameluz® PDT in Superficial Basal Cell Carcinoma

Prescription Drug User Fee Act (PDUFA) target action date set for September 28, 2026If approved, Ameluz® would be the first and only PDT ...

Healio

FDA clears investigational new drug application for ER-100

Life Biosciences plans to begin human clinical trials of a cellular rejuvenation therapy in optic neuropathies after ...

CURE

FDA to Review New Drug Combo for Previously Treated Metastatic Colorectal Cancer

“Exelixis Announces U.S. FDA Accepted the New Drug Application for Zanzalintinib in Combination with an Immune Checkpoint ...

MPR

FDA Grants Priority Review to Oveporexton for Narcolepsy Type 1

Oveporexton is designed to promote wakefulness and reduce abnormal REM-sleep-like phenomena, including cataplexy, in patients with NT1.

12d

Elevar Therapeutics Announces FDA Acceptance of New Drug Application Resubmission for Rivoceranib in Combination with Camrelizumab as a First-line Systemic Treatment for ...

Elevar Therapeutics, Inc., a majority-owned subsidiary of HLB Co., Ltd. and a fully integrated biopharmaceutical company dedicated to elevating treatment experiences and outcomes for patients who have ...

Healio

FDA clears investigational new drug application for NOV05

The FDA cleared an investigational new drug application to advance NOV05 in a phase 2 clinical trial in noninfectious ...

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