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July 30, 2026 16:05 ET | Source: Abivax

Abivax Announces Positive Pre-NDA Interaction with the FDA for Obefazimod

Abivax Announces Positive Pre-NDA Interaction with the FDA for Obefazimod Company remains on track to submit its first New Drug Application for obefazimod for the treatment of moderately to severely...
July 30, 2026 16:05 ET | Source: Abivax

Abivax annonce un retour positif de la FDA à l’issue de ses échanges pré-NDA concernant l’obéfazimod

Abivax annonce un retour positif de la FDA à l’issue de ses échanges pré-NDA concernant l’obéfazimod La Société confirme être en bonne voie pour déposer, d’ici la fin de l’année 2026, sa première...
July 30, 2026 10:19 ET | Source: AscellaHealth, LLC

AscellaHealth Delivers Mid-Year Specialty Pharmacy Outlook to Help Payers Navigate Pipeline Innovation, Cost and Benefit Strategy

AscellaHealth Delivers Mid-Year Specialty Pharmacy Outlook to Help Payers Navigate Pipeline Innovation, Cost and Benefit Strategy
July 30, 2026 08:30 ET | Source: Clearmind Medicine Inc.

Clearmind Announces Positive Safety Findings for CMND 100, Demonstrating Consistent Tolerability Throughout Full Dose Escalation in Part A of its FDA-Regulated Clinical Trial

Vancouver, Canada, July 30, 2026 (GLOBE NEWSWIRE) -- Clearmind Medicine Inc. (Nasdaq: CMND), a clinical-stage biotechnology company pioneering nonhallucinogenic neuroplastogenderived treatments for...
July 30, 2026 08:00 ET | Source: Mira Pharmaceuticals, Inc.

MIRA Pharmaceuticals Progresses MIRA-55 and SKNY-1 Toward IND-Enabling Studies

MIRA advances MIRA-55 and SKNY-1 through exploratory toxicology, CMC and manufacturing activities supporting future IND-enabling studies.
July 29, 2026 16:03 ET | Source: Sixty Degrees Pharmaceuticals

60 Degrees Pharmaceuticals Announces Minimum Enrollment Achieved in Hospitalized Babesiosis Study; Interim Data Readout Planned by October 6, 2026

60 Degrees Pharma reached minimum enrollment for interim analysis of its hospitalized babesiosis trial, with data expected by October 6, 2026.
July 29, 2026 15:28 ET | Source: FDA

FDA Licenses First-Ever Freeze-Dried Plasma Product in the U.S.

Silver Spring, MD, July 29, 2026 (GLOBE NEWSWIRE) -- The U.S. Food and Drug Administration today licensed Ezplaz Freeze Dried Plasma (FDP), making it the first freeze-dried plasma product licensed...
July 29, 2026 10:00 ET | Source: Smith & Nephew UK Ltd

Smith+Nephew’s TESSA™ Spatial Surgery System granted De Novo classification by the FDA sparking a generational leap in Sports Medicine for personalized planning and procedural innovation

Smith+Nephew’s TESSA Spatial Surgery System granted De Novo classification by the FDA; a generational leap in Sports Medicine for personalized planning
July 28, 2026 08:59 ET | Source: AGC Biologics, Inc.

AGC Biologics Lands Commercial Manufacturing Agreement for Yokohama Site Worth Hundreds of Millions of Dollars

Ahead of the official opening of AGC Biologics’ Yokohama site, a customer has already secured half of the facility’s manufacturing capacity.
July 28, 2026 07:50 ET | Source: Firefly Neuroscience, Inc.

Firefly Neuroscience (NASDAQ: AIFF) and Next Health Launch Precision Cognitive Health Initiative as FDA Advisory Committee’s Recommendation Backs Broader Access to Key Neuroprotective Peptides

– FDA Advisory Committee voted to recommend easing compounding restrictions for six peptides, including Epitalon and Semax, late last week – – These two peptides have attracted growing scientific...