FDA Rejects Hearing for Stomach Paralysis Drug Tradipitant

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2026-06314 — Determination That INAPSINE (Droperidol) Injection, 2.5 Milligrams/Milliliter, Was Not Withdrawn From Sale for Reasons of Safety or Effectiveness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

2026-05913 — 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.

2026-05772 — General and Plastic Surgery Devices; Reclassification of Optical Diagnostic Devices for Melanoma Detection and Electrical Impedance Spectrometers, To Be Renamed Software-Aided Adjunctive Diagnostic Devices for Use on Skin Lesions by Physicians Trained in the Diagnosis and Management of Skin Cancer

The FDA is changing the rules for certain skin cancer detection devices, moving them from a strict category (Class III) to a less strict one (Class II) with special safety checks. These devices, now called software-aided tools for skin lesion diagnosis, must be used by doctors trained in skin cancer. The new rules start April 24, 2026, making it easier and safer for doctors to use these helpful tools without extra costly hurdles.

Previous: 2026-06186 — Combined Notice of Filings

The Federal Energy Regulatory Commission got new filings about natural gas pipeline rates and company name changes. These updates could affect pipeline customers and companies, with some changes starting as soon as April 1, 2026. If you want to speak up or protest, you need to act by early April deadlines.

Next: 2026-06188 — Agency Information Collection Activities: Proposed Collection: Public Comment Request; Information Collection Request Title: Black Lung Clinics Program Performance Measures, OMB No. 0915-0292-Revision

HRSA is updating how Black Lung Clinics report their yearly progress to make things clearer and easier for them. This affects clinics helping coal miners with lung disease, and HRSA wants your thoughts before finalizing the changes. Comments are due by June 1, 2026, and the update aims to keep the program effective without adding extra hassle or cost.