Becker's ASC

The New Phase of Physician-Hospital Alignment

At the 18th Annual Ambulatory Surgery Centers Conference in Chicago on Oct. 28, Kate Lovrien, senior manager, and Luke Peterson, national director of the strategy group, Kurt Salmon Associates, ...
manilatimes

Cloudbreak Pharma Announces Successful End-of-Phase-2 Meeting and Alignment with FDA on Phase 3 Path Forward for CBT-004

CBT-004, if approved, would be the first and only treatment for pinguecula, an ophthalmic condition impacting more than 50 million people in the U.S. alone In prior studies, CBT-004 demonstrated an ...
Seeking Alpha

Aardvark Therapeutics Announces FDA Alignment on Protocol Amendment Expanding Phase 3 HERO Trial Population for Prader-Willi Syndrome

SAN DIEGO, Oct. 08, 2025 (GLOBE NEWSWIRE) -- Aardvark Therapeutics, Inc. (AARD), a clinical-stage biopharmaceutical company focused on developing novel, small-molecule therapeutics to activate innate ...

Solid Biosciences stock rises after FDA alignment on Phase 3 trial design

The life sciences company reported it has reached alignment with the U.S. Food and Drug Administration (FDA) on the design of its Phase 3 clinical trial, IMPACT DUCHENNE, for SGT-003. The FDA agreed ...
Nasdaq

Ocugen Gains FDA Alignment on Key Aspects of OCU400—Modifier Gene Therapy—Pivotal Phase 3 Study Design

MALVERN, Pa., Dec. 21, 2023 (GLOBE NEWSWIRE) -- Ocugen, Inc. (Ocugen or the Company) (NASDAQ: OCGN), a biotechnology company focused on discovering, developing, and commercializing novel gene and cell ...
Nasdaq

IMUNON, Inc. Advances IMNN-001 for Ovarian Cancer with FDA Alignment on CMC Strategy Ahead of Phase 3 Trial

IMUNON announced FDA alignment on CMC strategy for IMNN-001, preparing for a Phase 3 trial in advanced ovarian cancer. IMUNON, Inc. announced a successful Type C Chemistry, Manufacturing, and Controls ...
Seeking Alpha

Immuneering Advances Towards Dosing First Patient in Phase 3 Atebimetinib Trial for First-Line Metastatic Pancreatic Cancer Patients, Securing Alignment with FDA and EMA

– Overall survival update for Phase 2a trial of atebimetinib + mGnP in first-line pancreatic cancer patients planned in coming weeks – NEW YORK, Dec. 17, 2025 (GLOBE NEWSWIRE) -- Immuneering ...
Investing

OKYO Pharma receives FDA alignment on Phase 2b/3 trial for NCP treatment

"This alignment represents an important step forward and underscores the potential to address a significant unmet medical need in patients with neuropathic corneal pain," said Raj Patil, Chief ...
Morningstar

Clearside Biomedical Announces Successful End-of-Phase 2 Meeting with the FDA and Alignment on Phase 3 Plans for Suprachoroidal CLS-AX in Wet AMD

- Flexible Dosing and Extended Duration would be Important Differentiators from Existing Approved Therapies and Other Tyrosine Kinase Inhibitors in Development - ALPHARETTA, Ga., March 06, 2025 (GLOBE ...