What regulatory approvals or warnings exist regarding MemoBlast from the FDA or other health agencies?

1. No direct FDA record for “MemoBlast” in the provided materials

A thorough check of the documents you supplied shows no article, press release, or FDA docket entry that names a product called “MemoBlast.” The sources include FDA newsroom listings, FDA approval calendars, and news pieces about other drug reviews, but none identify MemoBlast as approved, under review, or the subject of a warning (available sources do not mention MemoBlast) ^{[2] [3] [1]}.

2. What the provided FDA sources do cover — hormone therapy labeling changes

Several of the supplied items discuss a significant FDA action in November 2025: HHS and FDA initiatives to remove or revise boxed (“black box”) warnings for menopausal hormone therapy and to update labeling language about cardiovascular disease, breast cancer, and dementia risks ^{[4] [5] [7]}. These items are the clearest examples in your dataset of recent regulatory labeling changes and show how the FDA can act across an entire drug class rather than only individual products ^{[4] [7]}.

3. Related FDA coverage in the dataset — drug approval scheduling and pressrooms

The results you provided include several calendar-style and newsroom items that track FDA review timelines and expected decision (PDUFA) dates for unrelated medicines (e.g., listings of expected FDA decisions in November/December 2025 and the FDA newsroom feed) ^{[1] [8] [9] [2]}. These show how industry and press outlets commonly use FDA public schedules to report on regulatory activity, but they do not connect to MemoBlast ^{[1] [2]}.

4. Mesoblast materials dominate the dataset — approvals, reviews, and label activity

A substantial portion of the sources concern Mesoblast’s remestemcel‑L (Ryoncil/Remestemcel‑L) — including its FDA approval for pediatric steroid‑refractory acute graft‑versus‑host disease in late 2024 and subsequent regulatory interactions about other Mesoblast cell therapies and BLAs ^{[6] [10] [11] [12]}. If you encountered “MemoBlast” in reporting, it is possible the name was conflated with Mesoblast or another similar-sounding company; however, the supplied documents do not make that link explicitly ^{[6] [10]}.

5. How to interpret silence in the record — limitations and next steps

Silence in these sources does not prove MemoBlast has no regulatory history; it only means the documents you gave do not mention it. To conclusively determine FDA approvals, warnings, or enforcement actions for a particular product name, one should search primary FDA databases (Drugs@FDA, MedWatch safety alerts, FDA press releases) and company filings. Those specific sources are not present in the dataset you provided, so I cannot cite them here (available sources do not mention MemoBlast) ^{[3] [2]}.

6. Potential pitfalls and alternative explanations

Two plausible explanations consistent with the provided material: (a) MemoBlast is an informal, brand, or misremembered name and the regulatory documents in your dataset refer to other drugs (e.g., Mesoblast’s products), or (b) MemoBlast is an investigational product or a non‑U.S. product not covered in these sources. The dataset does show recent FDA activity across classes (label removals for hormone therapy) and detailed regulatory engagements for Mesoblast, demonstrating how regulatory news is typically reported — but it does not validate any claims about MemoBlast itself ^{[4] [11] [6]}.

If you want, I can:

• Search FDA’s public databases and MedWatch for MemoBlast-specific entries (requires additional sources beyond those you supplied); or
• Check whether “MemoBlast” might be a misnomer for Mesoblast or another product in the supplied articles and summarize any matching regulatory actions from the provided sources (e.g., Mesoblast remestemcel‑L approvals and meetings with FDA) ^{[6] [10]}.