FDA Expands Biktarvy® Indication for HIV Treatment

- Biktarvy Now First and Only INSTI-Based Single-Tablet Regimen That is FDA Approved and DHHS Guideline Recommended for People Who are Virologically ...

February 27, 2024 | Tuesday | News
FDA Approves Groundbreaking SIMLANDI as First Interchangeable, High-Concentration Biosimilar to Humira

SIMLANDI is the first citrate-free, high-concentration biosimilar to be designated interchangeable to Humira in the U.S. SIMLANDI is the first biosimil...

February 26, 2024 | Monday | News
Sarepta's ELEVIDYS Supplement Accepted by FDA for Duchenne Treatment Expansion

ChatGPT CAMBRIDGE, Mass.--(BUSINESS WIRE)--February 16, 2024 07:00 AM Eastern Standard Time Sarepta Therapeutics, Inc. (NASDAQ:...

February 19, 2024 | Monday | News
FDA Grants Orphan-Drug Designation to Mesoblast's Revascor® for Congenital Heart Disease in Children

Mesoblast's Chief Executive, Silviu Itescu, expressed satisfaction with the FDA's decision: “We are very pleased to have now been granted both Orphan...

February 15, 2024 | Thursday | News
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

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