MoonLake: Positive FDA Meeting Spurs Momentum Ahead Of BLA Submission

MoonLake regains momentum after the FDA Type B meeting allows BLA submission for sonelokimab in HS without additional trials.

Aspire Biopharma Announces Successful Pre-IND Meeting with FDA for High-Dose Sublingual Aspirin (OTASA)

FDA feedback supports 505(b)(2) filing in H2 2026; No additional studies required beyond current planned 32-subject ...
Targeted Oncology

FDA Type B Meeting Offers Direction for Rhenium Re 186 Obisbemeda in LM

A Type B meeting between the FDA and Plus Therapeutics offered clarity and direction for the next steps in development of ...
FOX59 News

Polyrizon Completes FDA Pre-Submission Meeting for PL-14 Allergy Blocker Nasal Spray

Ra’anana, Israel, Dec. 08, 2025 (GLOBE NEWSWIRE) -- Polyrizon Ltd. (Nasdaq: PLRZ) (“Polyrizon” or the “Company”), a biotechnology company focusing on the development of intranasal products, today ...
Seeking Alpha

Organogenesis Announces Successful FDA Meeting and Plan to File BLA for ReNu® for Knee Osteoarthritis Pain

CANTON, Mass., Dec. 15, 2025 (GLOBE NEWSWIRE) -- Organogenesis Holdings Inc. (ORGO), a leading regenerative medicine company focused on the development, manufacture and commercialization of product ...
WREG

Saol Therapeutics Has Been Granted a Type A Meeting with the FDA to Determine the Path Forward for SL1009 in Pyruvate Dehydrogenase Complex Deficiency (PDCD)

FDA grants a Type A meeting on December 18th to review new and expanded datasets submitted by Saol to help identify a feasible path forward without the need for an additional clinical trial ROSWELL, ...