RAPS

FDA Offers New Guidance on Interpretation of BPCIA

The US Food and Drug Administration (FDA) on Friday released draft guidance on its interpretation of the "deemed to be a license" provision of the Biologics Price Competition and Innovation Act (BPCIA ...
RAPS

DeGette Looks to Codify FDA Stance on Exclusivity for Deemed Biologics

As part of a push to increase insulin competition and bring down the price of insulin, Rep. Diana DeGette (D-CO) and Tom Reed (R-NY) introduced a bill on Monday that aims to make certain US Food and ...
Seeking Alpha

Theriva Biologics Announces Orphan Drug Designation Granted by the U.S. FDA for VCN-01 for the Treatment of Pancreatic Cancer

ROCKVILLE, Md., June 27, 2023 (GLOBE NEWSWIRE) -- Theriva Biologics (NYSE American: TOVX), (“Theriva” or the “Company”), a clinical-stage company developing therapeutics designed to treat cancer and ...
Becker's Hospital Review

Amgen sues FDA over drug exclusivity rights: 5 things to know

Amgen on May 25 filed a lawsuit against the Food and Drug Administration after the agency denied the drugmaker a six-month exclusivity period for its secondary hyperparathyroidism treatment Sensipar, ...
Seeking Alpha

Vanda Announces Submission of Biologics License Application to the FDA for Imsidolimab for the Treatment of Generalized Pustular Psoriasis

WASHINGTON, Dec. 15, 2025 /PRNewswire/ -- Vanda Pharmaceuticals Inc. (Vanda) (Nasdaq: VNDA) today announced the submission of a Biologics License Application (BLA) to the U.S. Food and Drug ...
Targeted Oncology

FDA Grants Orphan Drug Designation for Rhenium (186Re) Obisbemeda in Pediatric Brain Cancer

Orphan drug designation targets rare, high-morbidity pediatric CNS tumors and provides incentives including seven-year ...