Savara Secures Key European Patent for MOLBREEVI as It Prepares Global Regulatory Filings

Savara Inc. (Nasdaq: SVRA) (the Company), a clinical stage biopharmaceutical company focused on rare respiratory diseases, announced the EPO notified the...

December 12, 2025 | Friday | News
Prilenia and Ferrer Receive FDA Clearance to Begin 500-Patient Pivotal Phase 3 ALS Study of Pridopidine

Prilenia Therapeutics B.V. and Ferrer  announced that the US Food and Drug Administration (FDA) has cleared the start of the pivotal, 500-patient, r...

December 12, 2025 | Friday | News
China Approves InnoCare’s Breakthrough TRK Inhibitor Zurletrectinib for Adult and Adolescent Solid Tumors

InnoCare Pharma (HKEX: 09969; SSE: 688428), a leading biopharmaceutical company, announced that its next-generation TRK inhibitor, zurletrectinib (ICP-72...

December 12, 2025 | Friday | News
SOLVD Health Launches Studies To Validate GLP 1 Patient Stratification Diagnostic Platform

SOLVD Health, a patient intelligence company developing cutting-edge precision solutions to deliver better health outcomes, announced the launch of two s...

December 10, 2025 | Wednesday | News
Resmed Receives FDA Clearance for Smart Comfort, the First AI-Enabled Tool for Personalized CPAP Therapy Settings

Resmed , the leading health technology company focused on sleep, breathing and care delivered in the home, announced it has received U.S. Food and Drug A...

December 09, 2025 | Tuesday | News
Incyte Announces FDA Breakthrough Therapy Designation for INCA033989 for Essential Thrombocythemia with Type 1 CALR Mutation

Incyte  announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy designation to INCA033989, a first-in-class muta...

December 08, 2025 | Monday | News
Bayer Initiates Phase IIa ASSESS Trial of Investigational Antibody BAY 3401016 for Alport Syndrome

BAY 3401016 is an investigational monoclonal antibody with potential to block a protein called Semaphorin 3A (Sema3A), which is thought to be involve...

December 05, 2025 | Friday | News
Insulet Receives FDA Clearance for Major Omnipod 5 Algorithm Upgrade Featuring New 100 mg/dL Target Glucose Setting

New 100 mg/dL Target Glucose setting offers more customization and tighter glucose management. Enhanced algorithm helps users remain in Automated Mo...

December 05, 2025 | Friday | News
Roche’s 15-Minute PCR Test for Whooping Cough Receives FDA Clearance and CLIA Waiver

The point-of-care test delivers PCR-accurate results in just 15 minutes, enabling healthcare providers to act quickly and prevent severe complications ...

December 02, 2025 | Tuesday | News
Cullinan’s FLT3-Targeted T Cell Engager CLN-049 Receives FDA Fast Track for R/R AML

Promising efficacy and favorable safety data from the Phase 1 study in heavily pre-treated patients show potential of CLN-049 to address a broad populati...

December 02, 2025 | Tuesday | News
Regeneron and Tessera Partner on One-Time Gene Writing Therapy for Alpha-1 Antitrypsin Deficiency

TSRA-196 is a potential one-time treatment to precisely correct the genetic mutation underlying AATD, with Investigational New Drug filing expected by ...

December 02, 2025 | Tuesday | News
BeOne Medicines’ Sonrotoclax Granted FDA Priority Review for Relapsed or Refractory Mantle Cell Lymphoma

BeOne Medicines Ltd. (Nasdaq: ONC; HKEX: 06160; SSE: 688235), a global oncology company, announced that the U.S. Food and Drug Administration (FDA) has a...

November 27, 2025 | Thursday | News
AstraZeneca’s IMFINZI Plus FLOT Receives US Approval as First Neoadjuvant Immunotherapy for Early Gastric and GEJ Cancers

AstraZeneca’s IMFINZI® (durvalumab) in combination with standard-of-care FLOT chemotherapy (fluorouracil, leucovorin, oxaliplatin, and docetaxe...

November 27, 2025 | Thursday | News
GE HealthCare Receives FDA Authorization for Pristina Recon DL, a Breakthrough in AI-Enhanced 3D Mammography

GE HealthCare (Nasdaq: GEHC) announced that it has received FDA Premarket Authorization for Pristina Recon DL, an advanced 3D mammography image reconstru...

November 27, 2025 | Thursday | News

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