FDA Hands Fast-Pass Voucher to Rare Disease Kid Drug Maker

2026-06478 — Determination of Regulatory Review Period for Purposes of Patent Extension; VYLOY

The FDA has officially set the review period for VYLOY, a human biological product, so its patent holder can apply for extra patent time. This affects the company behind VYLOY, giving them a chance to extend their patent protection and potentially boost profits. If anyone thinks the dates are wrong or wants to challenge the company’s review speed, they must act by June 2 or September 30, 2026.

2026-06481 — Determination of Regulatory Review Period for Purposes of Patent Extension; HYMPAVZI

The FDA has set the official review period for HYMPAVZI, a new human biological product, so its patent holder can apply for extra patent time. This affects the company behind HYMPAVZI and anyone interested in patent extensions. If you think the dates are wrong or want to challenge the company’s diligence, you have until June 2 or September 30, 2026, to speak up—potentially impacting patent length and market exclusivity.

2026-06480 — Determination of Regulatory Review Period for Purposes of Patent Extension; EMRELIS

The FDA has officially set the review period for EMRELIS, a medicine patent, so the patent owner can apply for extra protection time. If anyone thinks the dates are wrong, they have until June 2, 2026, to speak up. Also, people can challenge whether the patent owner was diligent during the review by September 30, 2026. This affects patent holders and could impact how long they keep exclusive rights to their product.

2026-06479 — Determination of Regulatory Review Period for Purposes of Patent Extension; ENFLONSIA

The FDA has set the official review period for ENFLONSIA, a human biological product, so its patent holder can apply for extra patent time. This affects the company behind ENFLONSIA and anyone interested in patent rules. If you think the dates are wrong or want to challenge the company’s review speed, you have until June 2 or September 30, 2026, to speak up—potentially impacting patent length and market exclusivity.

2026-06477 — Determination of Regulatory Review Period for Purposes of Patent Extension; ENCELTO

The FDA has officially set the review period for ENCELTO, a medicine patent, so the company can apply to extend its patent protection. This affects the drug maker by potentially giving them more time to exclusively sell ENCELTO, which can mean more money. If anyone thinks the dates are wrong or the company wasn’t diligent, they have until June 2 or September 30, 2026, to speak up.

2026-06483 — Determination of Regulatory Review Period for Purposes of Patent Extension; INJECTAFER

The FDA has officially set the review period for INJECTAFER, a drug patent up for extension. This means the company can apply to extend their patent protection, potentially keeping their exclusive rights longer and impacting competition and pricing. If anyone thinks the dates are wrong or the company wasn’t diligent, they can speak up by June 2 or September 30, 2026.

Previous: 2026-03210 — Notice of Formal Determination on Records Release

The Civil Rights Cold Case Records Review Board decided to release almost all of the 822 pages of records about two important civil rights cases, with just a tiny bit postponed. This means the public will soon get access to these historic documents, following the law’s rules to share info quickly. No extra costs or delays are expected, and the decision was made official in February 2026.

Next: 2026-03212 — Agency Information Collection Activities; Proposed eCollection eComments Requested; Reinstatement With Change of a Previously Approved Collection; Office for Victims of Crime Training and Technical Assistance Center (OVC TTAC) Feedback Form Package

The Department of Justice wants to bring back and update a feedback form used by the Office for Victims of Crime Training and Technical Assistance Center. This change aims to make it easier and quicker for people to share their thoughts, using more electronic options. Anyone who uses or benefits from OVC TTAC services can comment until April 20, 2026, helping shape how the form works without adding extra hassle or cost.