STAT1d
As officials prepare for WHO-led flu vaccine meeting, many wonder: Will the U.S. show?
Each year, flu experts from around the world gather to map out recommendations for next winter's flu vaccine. This year, it's ...
OS Therapies gears up for FDA meeting on cancer drug
NEW YORK - OS Therapies, Inc. (NYSE-A: OSTX), a small-cap biotech firm with a market capitalization of $42 million focusing on cancer treatment solutions, has announced the completion of its Phase 2b ...
Travere Therapeutics stock soars on FDA meeting outcome
Shares of Travere Therapeutics (NASDAQ:TVTX) surged 14% Tuesday following the company's announcement of a successful Type C ...
Business Insider11d
Spur Therapeutics Announces Successful End-of-Phase 2 Meeting with FDA for FLT201, Its Gene Therapy Candidate for Gaucher Disease
meeting with the U.S. Food and Drug Administration (FDA), supporting its planned Phase 3 trial for FLT201, an adeno-associated virus (AAV) gene therapy candidate for Gaucher disease type 1.
JD Supra8d
FDA’s Rare Disease Innovation Hub Releases Strategic Agenda: Implications for Stakeholders in 2025
In honor of Rare Disease Day on February 28, 2025, we will publish a series of posts throughout the month on As Prescribed ...
Yahoo Finance25d
Awakn Announces Positive Outcome of Pre-IND Meeting with FDA for AWKN-002 in Alcohol Use Disorder
Prof. David Nutt, Chief Research Officer of Awakn, added, "The FDA's recognition of our development strategy, and their willingness to support progression to Phase 2b, further validates the ...
The American Journal of Managed Care11d
OIG Report Seeks Better Oversight, Records for FDA’s Accelerated Approvals
Amid the uproar over the firing of 18 inspectors general, a report offering a coda to the aducanumab approval episode has ...
Pharmabiz2d
INmune Bio to submit BLA with US FDA seeking approval of CORDStrom to treat recessive dystrophic epidermolysis bullosa in paediatric patients
Boca Raton, Florida Wednesday, February 12, 2025, 16:00 Hrs [IST] ...
Nasdaq10d
Northstrive Biosciences Inc. Advances Obesity Treatment Candidates EL-22 and EL-32 with FDA Pre-IND Meeting Preparation
The company is preparing for a pre-Investigational New Drug meeting with the U.S. FDA and plans to file an Investigational New Drug application for EL-22 in 2025, following successful preclinical ...
manilatimes1d
Ryoncil® FDA Approval and Market Launch Highlighted at Tandem Transplantation Meetings
Mesoblast Limited (Nasdaq:MESO; ASX:MSB), a global leader in allogeneic cellular medicines for inflammatory diseases, today ...
Spur Therapeutics Announces Successful End-of-Phase 2 Meeting with FDA for FLT201, Its Gene Therapy Candidate for Gaucher Disease
FDA aligned on single-arm Phase 3 study to support potential accelerated and full approval On track to dose first patient in Phase 3 trial in second half of 2025 LONDON, Feb. 03, 2025 (GLOBE NEWSWIRE) ...