RAPS

FDA publishes NDA filing checklist to avoid application derailments

The US Food and Drug Administration (FDA) published the internal checklists its staff reference when reviewing drug and biologics applications to determine whether the submission is complete, or ...

ABBV Seeks FDA Nod for Rinvoq Label Expansion in Alopecia Areata

AbbVie files for the FDA approval of Rinvoq in alopecia areata, backed by phase III data showing strong hair regrowth and ...
Seeking Alpha

Biofrontera Announces FDA Filing Acceptance of Supplemental New Drug Application for Ameluz ...

WOBURN, Mass., Feb. 11, 2026 (GLOBE NEWSWIRE) -- Biofrontera Inc. (BFRI) (“Biofrontera” or the “Company”), a biopharmaceutical company specializing in the commercialization and development of ...
Nasdaq

FDA Extends Review Period of Sanofi's Multiple Sclerosis Drug Filing

Sanofi SNY announced that the FDA has extended the target action date for its new drug application (NDA) for tolebrutinib by three months. The NDA is seeking approval of tolebrutinib, an oral and ...
来自MSN

FDA accepts SNY filing for expanded use of T1D drug in young children

Sanofi SNY announced that the FDA has accepted a regulatory filing seeking to expand the use of its type 1 diabetes (T1D) drug, Tzield (teplizumab), in individuals aged one year and older. The agency ...