Radiopharm Theranostics Schedules FDA Meeting for RAD101 Phase 3 Trial

RAD 101 Phase 2b trial demonstrated 93% concordance with MRI across all evaluable lesions, meeting the Phase 2 trial's primary endpoint End-of-Phase 2 m...

August 19, 2026 | Wednesday | News
Bristol Myers Squibb Receives FDA Accelerated Approval for ZENBEXUS in Multiple Myeloma

-Bristol Myers Squibb announced that the U.S. Food and Drug Administration (FDA) has approved ZENBEXUS™ (iberdomide) in combination with darat...

August 18, 2026 | Tuesday | News
QIAGEN Wins FDA Clearance for QIAstat-Dx Bloodstream Infection Panel

QIAstat-Dx BCID GPF Plus AMR Panel detects 20 pathogen targets and 10 antimicrobial resistance markers from positive blood cultures in about one hour...

August 12, 2026 | Wednesday | News
Fresenius Kabi Recalls Tyenne Injection Lot Over Glass Particle Contamination

Fresenius Kabi, an operating company of the Fresenius Group, is recalling one lot of Tyenne® (tocilizumab-aazg) Injection 400 mg/20 mL (20 mg/mL)20 m...

August 12, 2026 | Wednesday | News
Takeda Receives FDA Approval for ORZEYFUL to Treat Adults with Narcolepsy Type 1

Adults Taking ORZEYFUL Experienced Significant and Meaningful Improvements Across the Full Range of Symptoms of Narcolepsy Type 1 (NT1) in Clinical T...

August 07, 2026 | Friday | News
IQVIA and Medera Partner to Advance Cardiac Gene Therapy Development

IQVIA (NYSE:IQV), a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healt...

August 06, 2026 | Thursday | News
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
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
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
FDA Approves Eisai and Biogen’s LEQEMBI IQLIK for At-Home Initiation of Alzheimer’s Treatment

LEQEMBI IQLIK is a first-of-its-kind anti-amyloid treatment worldwide, offering at-home dosing for initiation and maintenance (approved in the U.S.)...

July 15, 2026 | Wednesday | News
Sanofi Wins FDA Approval for Subcutaneous Sarclisa Escena with On-Body Injector

Sanofi’s subcutaneous Sarclisa Escena approved in the US as first anticancer treatment administered via on-body injector Sarclisa Escena admini...

July 14, 2026 | Tuesday | News
Elevar Therapeutics Receives FDA Complete Response Letter for Rivoceranib-Camrelizumab NDA

Elevar Therapeutics, Inc., a majority-owned subsidiary of HLB Co., Ltd. and a fully integrated biopharmaceutical company dedicated to elevating treatment...

July 14, 2026 | Tuesday | News
FDA Expands Padcev–Keytruda Approval, Broadening Treatment Options for Muscle-Invasive Bladder Cancer

The US Food and Drug Administration (FDA) has expanded the approved indication for the Padcev (enfortumab vedotin) and Keytruda (pembrolizumab) combination...

July 13, 2026 | Monday | News
FDA Expands Approval of Vertex’s CASGEVY to Children Aged Two and Older with Sickle Cell Disease and Beta Thalassemia

- First and only approved genetic therapy to treat children as young as 2 years for both severe sickle cell disease and transfusion-dependent beta thal...

July 03, 2026 | Friday | Regulatory

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