OS Therapies Initiates FDA BLA Filing for OST-HER2 to Prevent or Delay Recurrent Pulmonary Metastatic Osteosarcoma

Regenerative Medicine Advanced Therapy (RMAT) designation requests update submitted to FDA with recent biomarker data ...
Fierce Biotech

UPDATE: After Moderna's rebuke, HHS stands behind FDA decision to spurn mRNA flu filing

After the FDA's surprise refusal to take up a review of Moderna's next-gen flu vaccine, the public disagreement between U.S.
Seeking Alpha

FDA accepts filing application for oral semaglutide 25 mg, which if approved, would be the first oral GLP-1 treatment for obesity

PLAINSBORO, N.J., May 2, 2025 /PRNewswire/ -- Today, Novo Nordisk announced that the U.S. Food and Drug Administration (FDA) accepted its New Drug Application (NDA) submission for an ...
Fierce Pharma

Ocular Therapeutix eyes FDA filing with ph. 3 wet AMD win over Eylea, but investors balk

Ocular Therapeutix reported a phase 3 win that it believes can validate its attempts to challenge Regeneron’s entrenched ...
CURE

FDA Accepts Filing of Ameluz for Superficial Basal Cell Carcinoma

The FDA has accepted a sNDA for Ameluz topical gel, used in combination with the RhodoLED red-light lamp series, for superficial basal cell carcinoma treatment.
pharmaphorum

FDA says comparator dose scuppered Moderna's flu jab filing

In its main clinical trial, mRNA-1010 was shown to be 26.6% more effective than the comparator flu shot in adults aged 50 ...