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June 18, 2025 07:00 ET | Source: BPGbio

BPGbio Announces Presentation of Preliminary Clinical Data of Investigational BPM31510 for Primary CoQ10 Deficiency

BPM31510 provides encouraging evidence of the potential for transformative benefit for a disease with high unmet need, supporting further development.The Company plans to seek guidance in Q3 2025 from...
June 17, 2025 13:42 ET | Source: BioAegis Therapeutics

BioAegis Therapeutics Receives FDA Fast Track Designation for Lead Product, Recombinant Human Gelsolin, for the Treatment of Acute Respiratory Distress Syndrome (ARDS)

Fast Track status enables expedited regulatory review timelines and supports the development of recombinant human plasma gelsolin (rhu-pGSN), a novel immune modulator for inflammatory diseases. ...
June 17, 2025 08:15 ET | Source: CERo Therapeutics Holdings, Inc.

CERo Therapeutics Holdings, Inc. Announces FDA Orphan Drug Designation Granted to CER-1236 for the Treatment of Acute Myeloid Leukemia (AML)

SOUTH SAN FRANSCISCO, Calif., June 17, 2025 (GLOBE NEWSWIRE) -- CERo Therapeutics Holdings, Inc., (Nasdaq: CERO) (“CERo” or the “Company”) an innovative immunotherapy company seeking to advance the...
June 16, 2025 08:00 ET | Source: Phathom Pharmaceuticals

Phathom Pharmaceuticals Announces FDA Correction to Orange Book Listing, Confirming 10 Years of Regulatory Exclusivity for VOQUEZNA® (vonoprazan) Tablets Through May 3, 2032

FLORHAM PARK, N.J., June 16, 2025 (GLOBE NEWSWIRE) -- Phathom Pharmaceuticals, Inc. (Nasdaq: PHAT), a biopharmaceutical company focused on developing and commercializing novel treatments for...
June 12, 2025 08:13 ET | Source: NetraMark Holdings Inc.

NetraMark Founder Coauthors New Publication on AI/ML Use in Clinical Trials, Alongside Authors From Leading Global Regulatory Organizations

TORONTO, June 12, 2025 (GLOBE NEWSWIRE) -- NetraMark Holdings Inc. (the “Company” or “NetraMark”) (CSE: AIAI) (OTCQB: AINMF) (Frankfurt: PF0), an artificial intelligence (AI) solutions company...
June 11, 2025 08:00 ET | Source: Chemomab Therapeutics

Chemomab Reports Positive Feedback From Two Recent FDA Meetings Supporting Phase 3 Advancement of Nebokitug in Primary Sclerosing Cholangitis

FDA agreement on CMC requirements and the timing of non-clinical toxicology testing are milestones further advancing nebokitug towards a PSC Phase 3 trial.
June 06, 2025 12:27 ET | Source: Phathom Pharmaceuticals

Phathom Pharmaceuticals Announces Positive FDA Decision to Recognize 10 Years of Regulatory Exclusivity for VOQUEZNA® (vonoprazan) Tablets through May 3, 2032

FLORHAM PARK, N.J., June 06, 2025 (GLOBE NEWSWIRE) -- Phathom Pharmaceuticals, Inc. (Nasdaq: PHAT) today announced that the U.S. Food and Drug Administration (FDA) has approved Phathom’s Citizen...
June 06, 2025 07:00 ET | Source: Arvinas Inc.

Arvinas Announces Submission of New Drug Application to U.S. FDA for Vepdegestrant for Patients with ESR1-Mutated ER+/HER2- Advanced or Metastatic Breast Cancer

– This submission is supported by the pivotal Phase 3 VERITAC-2 clinical trial, results of which were recently presented at the 2025 American Society for Clinical Oncology Annual Meeting and published...
June 02, 2025 07:05 ET | Source: uniQure Inc.

uniQure Provides Regulatory Update on AMT-130 for Huntington’s Disease

~ Alignment with FDA continues to support Accelerated Approval pathway ~ ~ BLA submission planned for first quarter of 2026 ~ ~ Conference call today at 8:30 a.m. ET ~ LEXINGTON, Mass. and...
May 30, 2025 16:15 ET | Source: Plus Therapeutics Inc.

Plus Therapeutics Reports First Quarter Financial Results and Recent Business Highlights

Plus Therapeutics Reports First Quarter Financial Results and Recent Business Highlights

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