TRYNGOLZA Drug Patent Extension Dates Finalized

2026-06379 — Issuance of Priority Review Voucher; Rare Pediatric Disease Product; KRESLADI (marnetegragene autotemcel)

The FDA just gave Rocket Pharmaceuticals a special priority review voucher for their rare pediatric disease treatment, KRESLADI, approved on March 26, 2026. This voucher speeds up future FDA reviews, helping get important medicines to kids with rare diseases faster. It’s a big win for patients, the company, and anyone cheering for quicker cures!

2026-06314 — Determination That INAPSINE (Droperidol) Injection, 2.5 Milligrams/Milliliter, Was Not Withdrawn From Sale for Reasons of Safety or Effectiveness

The FDA has decided that INAPSINE (droperidol) injection wasn’t taken off the market because of safety or effectiveness problems. This means generic versions can keep being approved and sold as long as they follow the rules. Patients and healthcare providers can keep trusting this medicine without worry, and drug makers can continue their work without delays or extra costs.

2026-06294 — Consideration of Acceptable Market Name Change for Certain Rockfish (Sebastes spp.); Request for Information

The FDA wants to hear from fishermen, seafood sellers, and fish lovers about possibly changing the official market names for certain rockfish species. This update aims to make fish labels clearer and safer for everyone, with comments open until May 1, 2026. If the name changes happen, it could affect how these fish are sold and marketed, so your input matters!

2026-06316 — Issuance of Priority Review Voucher; Rare Pediatric Disease Product; YUVIWEL (navepegritide)

The FDA just gave Ascendis Pharma a special priority review voucher for their rare pediatric disease drug, YUVIWEL, which helps kids with achondroplasia grow taller. This voucher speeds up future drug reviews and can be a valuable asset, saving time and potentially money. Approved on February 27, 2026, this move highlights the FDA’s commitment to fast-tracking treatments for rare childhood conditions.

2026-06187 — Notice of Decision on a Hearing Request Regarding a Proposal To Refuse To Approve a New Drug Application for TRADIPITANT Capsules

The FDA has decided not to approve Vanda Pharmaceuticals’ new drug, TRADIPITANT capsules, meant to treat symptoms of gastroparesis. Vanda asked for a hearing to challenge this, but the FDA denied it. This means patients and doctors will have to wait longer for this treatment, and Vanda faces delays and extra costs as they figure out their next move.

2026-05913 — Elite Laboratories, Inc., et al.; Withdrawal of Approval of 72 Abbreviated New Drug Applications; Correction

The FDA fixed a mistake about pulling approvals for 72 generic drug applications. One drug, a valproic acid capsule from Upsher-Smith Laboratories, won’t lose its approval because the company asked to keep it. This means the drug stays available, and the change took effect before October 23, 2025.

Previous: 2026-03849 — Determination of Regulatory Review Period for Purposes of Patent Extension; AEROPACE

The FDA has set the official review period for the medical device AEROPACE, which helps the company extend its patent protection. This means the company could get more time to keep exclusive rights to their invention, potentially affecting competitors and consumers. If anyone thinks the dates are wrong or the company wasn’t careful during the review, they can speak up by April 27 or August 25, 2026.

Next: 2026-03851 — Determination of Regulatory Review Period for Purposes of Patent Extension; TEVIMBRA

The FDA has officially set the review period for TEVIMBRA, a human biological product, which helps the company extend its patent protection. This means the patent clock can be paused, giving the maker more time to benefit from their invention. If anyone thinks the dates are wrong or wants to challenge the company’s effort during review, they must act by April 27 or August 25, 2026.