FDA Events for Aspire Biopharma (ASBP)
This section highlights FDA-related milestones and regulatory updates for drugs developed by Aspire Biopharma (ASBP).
Over the past two years, Aspire Biopharma has reported clinical trial outcomes, regulatory submissions, approvals, and other FDA events for drugs and therapies such as
BUZZ. For definitions of regulatory abbreviations such as NDA, BLA, or PDUFA, see the event status legend.
BUZZ BOMB - FDA Regulatory Timeline and Events
BUZZ BOMB is a drug developed by Aspire Biopharma for the following indication: New Sublingual Pre-Workout Supplement.
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- BUZZ BOMB
- Announced Date:
- July 9, 2025
- Indication:
- New Sublingual Pre-Workout Supplement
Announcement
Aspire Biopharma Holdings, Inc. announced positive initial consumer feedback from the Company's sampling of its sublingual pre-workout supplement, BUZZ BOMB™.
AI Summary
Aspire Biopharma Holdings, Inc. announced positive initial consumer feedback from sampling its sublingual pre-workout supplement, BUZZ BOMB™. This new product uses nano technology to deliver caffeine directly through the tissues under the tongue, offering rapid energy delivery and enhanced mental focus. With 50mg of caffeine per serving, BUZZ BOMB™ is designed to provide nearly instant energy for athletes and gym enthusiasts, making it a convenient alternative to traditional pre-workout mixes.
The supplement is available in four flavors, packaged in easy-to-use single servings. Early testers, including personal trainers and gym goers, praised its fast-acting benefits and ease of use, noting improvements in workout energy and endurance. Aspire Biopharma plans to officially launch BUZZ BOMB™ at the FITCON and Fit Expo conventions in August, aiming to make it a go-to energy solution in the competitive pre-workout market.
Read Announcement
Aspire Biopharma FDA Events - Frequently Asked Questions
As of now, Aspire Biopharma (ASBP) has not received any FDA approvals for its therapy in the last two years.
In the past two years, Aspire Biopharma (ASBP) has reported FDA regulatory activity for BUZZ BOMB.
The most recent FDA-related event for Aspire Biopharma occurred on July 9, 2025, involving BUZZ BOMB. The update was categorized as "Positive Feedback," with the company reporting: "Aspire Biopharma Holdings, Inc. announced positive initial consumer feedback from the Company's sampling of its sublingual pre-workout supplement, BUZZ BOMB™."
Currently, Aspire Biopharma has one therapy (BUZZ BOMB) targeting the following condition: New Sublingual Pre-Workout Supplement.
More FDA Event Resources from MarketBeat
FDA Event Stage Terminology & Abbreviation Guide
- NDA: New Drug Application
- ANDA: Abbreviated New Drug Application
- sNDA: Supplemental New Drug Application
- BLA: Biologics License Application
- sBLA: Supplemental Biologics License Application
- FDA Approved: Approved by the FDA
- EMA: European Medicines Agency
- CE Mark: European Union Certification
- NMPA: China National Medical Products Administration
- MHLW: Japanese Ministry of Health
- FDA Meeting: Consultation with FDA
- Pre-IND: Pre-Investigational New Drug Meeting
- Breakthrough Therapy: Special FDA designation for promising therapies
- Fast Track: Accelerated FDA approval pathway
- Orphan Drug: Designation for rare disease treatments
- RPD: Rare Pediatric Disease Designation
- RMAT: Regenerative Medicine Advanced Therapy
- DSMB Review: Data Safety Monitoring Board Review
- IDMC Review: Independent Data Monitoring Committee
- MAA: MHRA Marketing Authorization Application
- RTF: Refusal to File (Rejected Application)
- 510(k): FDA Clearance for Medical Devices
- Rolling Submission: Staggered regulatory review process
This page (NASDAQ:ASBP) was last updated on 7/10/2025 by MarketBeat.com Staff
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