In the third part of our FDA: Drug & Device Team’s series on biological products regulation, we investigate how to qualify for reference product exclusivity (RPE) under the Biologics Price Competition ...

Once the active ingredient is defined, an Applicant must select which patent, or patents, to put forward for extension. The statute permits only one PTE per regulatory review period, so the choice is ...

In the fourth part of our FDA: Drug & Device Team’s series on biological products regulation, we discuss the Food and Drug Administration’s requirements and standards for approval of biosimilar ...

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, ...

The FDA released Feb. 24 the first version of the Purple Book, a new online database of biological product information. The Purple Book is modeled after the Orange Book, a list of every prescription ...

Armata Pharmaceuticals, Inc. (NYSE American: ARMP) ("Armata" or the "Company"), a late clinical-stage biotechnology company ...

WASHINGTON, Sept 6 (Reuters) - Lawmakers are unlikely to add generic biologics legislation to a Food and Drug Administration bill expected to receive congressional approval this month, two key U.S.

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 ...

Phathom Pharmaceuticals Inc. (NASDAQ:PHAT) shares are trading higher Friday after the company announced a major regulatory win. What To Know: The FDA has granted 10-year new chemical entity ...