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April 08, 2026 09:00 ET | Source: MAIA Biotechnology, Inc.

MAIA Biotechnology Expects Recent $33 Million Capital Raise to Fully Fund Ongoing Pivotal Phase 3 Trial of Novel Telomere-Targeting Anticancer Therapy

Strong participation in recent $33 million common stock offering highlights investor confidence in late-stage clinical momentum and commercial potential Statistical assessments point to high...
April 08, 2026 08:00 ET | Source: CorTec GmbH

CorTec Receives FDA Breakthrough Device Designation for Its Brain Interchange System in Stroke Rehabilitation — the First BCI Worldwide Designated for Stroke Motor Rehabilitation

Freiburg, Germany, April 08, 2026 (GLOBE NEWSWIRE) -- CorTec GmbH, a pioneer in fully implantable brain-computer interfaces (BCI), today announced that the U.S. Food and Drug Administration (FDA)...
April 08, 2026 07:00 ET | Source: Immusoft

Immusoft Announces Presentation of World's First Patient Treated with an Engineered B Cell Therapy at Workshop Co-Hosted by FDA and ARM

SAN FRANCISCO, April 08, 2026 (GLOBE NEWSWIRE) -- Immusoft of CA, a clinical-stage biotechnology company pioneering engineered B cell therapies, today announced that it will present an invited...
April 07, 2026 07:00 ET | Source: TRiCares SAS

TRiCares Receives FDA Approval for TRICURE US IDE Pivotal Trial with the Topaz Tricuspid Valve Replacement System

Minneapolis, MN, USA and Paris, France and Munich, Germany, 7 April 2026 – TRiCares SAS (“TRiCares”), a privately held pioneer in the field of minimally invasive treatment of tricuspid regurgitation,...
April 02, 2026 08:00 ET | Source: Cocrystal Pharma, Inc.

Cocrystal Pharma Receives FDA Fast Track Designation for CDI-988 for Norovirus Infection Treatment and Preventive

FDA Fast Track designation supports accelerated development and expedites regulatory reviewNorovirus is responsible for an estimated 685 million global cases each year and approximately $60 billion in...
April 01, 2026 08:05 ET | Source: VivoSim Labs, Inc.

VivoSim Announces Pricing of up to a $4 Million Public Offering

SAN DIEGO, April 01, 2026 (GLOBE NEWSWIRE) -- VivoSim Labs, Inc. (Nasdaq: VIVS), (the “Company” or “VivoSim”), a provider of next-generation New Approach Methodologies (NAMs) for preclinical safety,...
April 01, 2026 07:01 ET | Source: Pasithea

Pasithea Therapeutics Announces Grant of Fast Track Designation by FDA to PAS-004 for Treatment of Neurofibromatosis Type 1 (NF1) Associated Plexiform Neurofibromas (PN) Causing Significant Morbidity

Pasithea Therapeutics Announces Grant of Fast Track Designation by FDA to PAS-004 for Treatment of NF1 Associated Plexiform Neurofibromas
March 31, 2026 11:02 ET | Source: Serenity Medical

Serenity Medical Receives U.S. FDA HDE Approval of the River™ Stent - the First Venous Stent Approved for Severe, Refractory Idiopathic Intracranial Hypertension (IIH)

Landmark regulatory milestone makes the River stent available for adults with severe IIH – a debilitating, historically undertreated condition – who have failed medical therapy Serenity Medical...
March 31, 2026 07:00 ET | Source: Agios Pharmaceuticals, Inc.

Agios Advances Mitapivat Toward Potential U.S. Accelerated Approval in Sickle Cell Disease Following Pre-sNDA Meeting with FDA

Agios announces it will pursue U.S. accelerated approval for mitapivat in sickle cell disease
March 30, 2026 16:05 ET | Source: Nutriband Inc.

Nutriband Selects Commercial Brand Name for Its Abuse Deterrent Fentanyl Patch

Name chosen for AVERSA Fentanyl commercial product