Novartis Secures FDA Approval for Pluvicto in Earlier-Stage Metastatic Prostate Cancer

Pluvicto now approved across PSMA+ metastatic prostate cancer, nearly doubling eligible patient population PSMAddition updated results show Pluvicto r...

August 04, 2026 | Tuesday | News
Building Confidence Beyond Compliance With Media Fills Designed for the Annex 1 Era

In the Annex 1 era, media fills must replicate the routine aseptic manufacturing process as closely as possible. This includes all critical manufacturing s...

August 03, 2026 | Monday | Expert Opinion
NeuroPace to Work with FDA After PMA Supplement for IGE Indication Receives Non-Approvable Letter

-- Company received communication from FDA indicating that the PMA Supplement for idiopathic generalized epilepsy is not approvable in its current form...

July 30, 2026 | Thursday | News
Takeda Reported Phase 3 Zasocitinib Data Showing Strong Skin Clearance in Plaque Psoriasis

Takeda (TSE:4502/NYSE:TAK) announced new data from the two pivotal Phase 3 studies of zasocitinib (TAK-279), a next-generation, highly selective and pote...

July 30, 2026 | Thursday | News
Arrowhead Completed Enrollment in Phase 3 YOSEMITE Trial of Zodasiran for HoFH

-Arrowhead Pharmaceuticals, Inc. (NASDAQ: ARWR) today announced that it has completed enrollment in the global Phase 3 YOSEMITE clinical trial of zodasir...

July 29, 2026 | Wednesday | News
Sanofi Discontinues Development of Amlitelimab for Atopic Dermatitis

Sanofi announced the discontinuation of clinical development of amlitelimab, an OX40-ligand monoclonal antibody, in moderate-to-severe atopic dermatitis ...

July 28, 2026 | Tuesday | News
Lundbeck Receives FDA Fast Track Designation for Narcolepsy Candidate Lu AH69593

Lundbeck announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to Lu AH69593, the company's lead oral orexin 2 rece...

July 27, 2026 | Monday | News
Fresenius Launches €200 Million Venture Fund to Invest in Healthcare Innovation

The issuer is solely responsible for the content of this announcement. Fresenius is further expanding its access to innovation networks through its own co...

July 27, 2026 | Monday | News
Bio-Thera Solutions Initiates Phase I Trial of CD25-Targeting ADC BAT8013 in Advanced Solid Tumors

Bio-Thera Solutions, Ltd. (SH: 688177), a commercial-stage pharmaceutical company, announced that dosing has begun in a Phase 1 clinical study evaluating B...

July 27, 2026 | Monday | News
Synaptiq Therapeutics Launches to Advance SYN-001 for 22q11DS Neuropsychiatric Symptoms

A consortium of European and US-based investors and Nobias Therapeutics announced the launch of Synaptiq Therapeutics, a privately held, clinical-stage bio...

July 27, 2026 | Monday | News
iVeena Receives FDA Support to Advance IVMED-85 into Phase 2 Trial for Pediatric Myopia

  FDA supports advancement of IVMED-85 into Phase 2 clinical development for pediatric myopia and provides alignment on key elements of the develop...

July 24, 2026 | Friday | News
AbelZeta Pharma Receives EMA PRIME Designation for C-CAR168 in Refractory Lupus

  AbelZeta Pharma, Inc. ("AbelZeta" or the "Company"), a global clinical-stage biopharmaceutical company focused on the discovery and development of ...

July 22, 2026 | Wednesday | News
Amneal Received FDA Approval for Additional Iohexol Injection Strengths and Vial Presentations

Approval of iohexol injection 350 mg iodine/mL in 50 mL, 75 mL and 100 mL vials, and 300 mg iodine/mL in 50 mL vial, significantly expands Amneal&rsquo...

July 21, 2026 | Tuesday | News
FDA Approved Merck’s Lipfendra as First Oral PCSK9 Inhibitor for High Cholesterol

The U.S. Food and Drug Administration approved Lipfendra (enlicitide), the first oral inhibitor of proprotein convertase subtilisin/kexin type ...

July 21, 2026 | Tuesday | News

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