Viz.ai Receives FDA 510(k) Clearance for Artificial Intelligence Algorithm for the Quantification of Intracerebral Hemorrhage

  Viz.ai, a pioneering force in AI-driven disease detection and intelligent care coordination, has attained a significant milestone with the receipt ...

February 12, 2024 | Monday | News
Rznomics Secures FDA Orphan Drug Designation for RZ-001 in Hepatocellular Carcinoma

The ODD granted to RZ-001 in HCC may allow it to receive 7 years of marketing exclusivity upon product approval, exemption from user fee and tax credits. T...

February 02, 2024 | Friday | News
Cabaletta Bio's CABA-201 Receives FDA Orphan Drug Designation for Myositis

“Myositis, believed to be driven by B cells, is a severe and potentially fatal autoimmune disease for which no curative therapy exists. Current treat...

February 02, 2024 | Friday | News
FDA Approves Faster Manufacturing Process for Yescarta® by Kite, a Gilead Company

Kite, a Gilead Company (Nasdaq: GILD), today announced that the U.S. Food and Drug Administration (FDA) has approved a manufacturing process change resulti...

January 31, 2024 | Wednesday | News
Sanofi's Dupixent® FDA Approved as First and Only Treatment for Children (1+) with Eosinophilic Esophagitis (EoE

Approval based on Phase 3 EoE KIDS trial showing a greater proportion of children taking Dupixent achieved histological remission compared to placebo&nbs...

January 26, 2024 | Friday | News
Neuralace Medical's Axon Therapy Cleared by FDA for Diabetic Neuropathy Pain

Neuralace Medical, Inc., an innovator in pain management technology,  proudly announces the FDA clearance of its groundbreaking product, Axon Therapy ...

January 15, 2024 | Monday | News
China's RemeGen's RC88 earns FDA Fast Track, heralding new hope for ovarian cancer patients

RemeGen Co. Ltd. ("RemeGen" or "the Company") (9995.HK, 688331.SH), a commercial-stage biotechnology company, announced recently that its independently dev...

January 15, 2024 | Monday | News
Pasithea Therapeutics' PAS-004 IND Application Accepted by FDA for Advanced Cancer Patient Evaluation.

-- Phase 1 dose escalation study in patients with MAPK pathway driven advanced solid tumors to begin in Q1 2024 – -- Initial readout expected as ear...

January 03, 2024 | Wednesday | News
Senhwa Biosciences Gains Taiwan FDA Approval for Silmitasertib Phase II Study in Viral-Associated Community-Acquired Pneumonia (CAP)

The trial is a phase II multi-center, randomized-controlled interventional prospective study, and the purpose of this trial is to investigate whether early...

December 27, 2023 | Wednesday | News
FDA Approves Label Update for Yescarta® CAR T-Cell Therapy with Overall Survival Data

Kite, a Gilead Company (Nasdaq: GILD), announced that the U.S. Food and Drug Administration (FDA) has approved a label update for Yescarta® (axicabtage...

December 22, 2023 | Friday | News
ALPCO Commercially Launches FDA-Cleared Calprotectin Assay

In July 2023, ALPCO unveiled the Calprotectin Immunoturbidimetric Assay at the American Association for Clinical Chemistry (now ADLM) annual meeting. This ...

December 20, 2023 | Wednesday | News
Neuronetics Receives 510(k) Clearance for NeuroSite™ Coil Placement Accessory

Neuronetics, Inc.  a medical technology company focused on designing, developing, and marketing products that improve the quality of life for patients...

December 19, 2023 | Tuesday | News
FDA Approves PADCEV® with KEYTRUDA® for Advanced Bladder Cancer

– PADCEV plus pembrolizumab approved based on groundbreaking EV-302 trial – – Confirmatory trial found PADCEV plus pembrolizumab nearly ...

December 18, 2023 | Monday | News
CHMP Greenlights Biogen's SKYCLARYS® for Rare Neurodegenerative Disease

Friedreich’s ataxia is a genetic, debilitating and life-shortening neuromuscular disease1 Milestone highlights Biogen’s growing portfolio in...

December 18, 2023 | Monday | News

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