Shorla Oncology's Palatable Oral Liquid for Leukemia Enters FDA Review Process

Shorla Oncology (‘Shorla’), a U.S.-Ireland specialty pharmaceutical company, announced  that the U.S. Food and Drug Administration (FDA) h...

April 08, 2024 | Monday | News
Key Proteo Advances Early Detection of Rare Genetic Disorders with FDA Submission of Newborn Screening Kit

Key Proteo, a pioneering proteomics diagnostics company specializing in the enhanced early detection of rare but treatable genetic disorders, today announc...

April 01, 2024 | Monday | News
LISCure Biosciences' LB-P8 Granted Fast Track Designation by FDA for Primary Sclerosing Cholangitis Treatment

LISCure Biosciences, a leading clinical-stage biopharmaceutical company focused on discovering and developing innovative microbiome-based therapies, a...

April 01, 2024 | Monday | News
FDA Approves Roche's First Molecular Test for Malaria Screening in Blood Donors

The cobas Malaria test is the first FDA-approved molecular test to screen U.S. blood donors for malaria Malaria is a serious and potentially fatal paras...

March 27, 2024 | Wednesday | News
 GE HealthCare Secures FDA 510(k) Clearance for IONIC Health’s nCommand Lite System to Alleviate Radiology Staffing Shortages

  GE HealthCare (Nasdaq: GEHC) announces the U.S. FDA 510(k) Clearance of IONIC Health’s revolutionary nCommand Lite technology, aimed at mitig...

March 26, 2024 | Tuesday | News
Johnson & Johnson Announces FDA Approval of OPSYNVI® as First Once-Daily Single-Tablet Combo Therapy for Pulmonary Arterial Hypertension (PAH)

   Johnson & Johnson has announced the approval of OPSYNVI® by the U.S. Food and Drug Administration (FDA), marking a significant advanc...

March 25, 2024 | Monday | News
Orchard Therapeutics Achieves Landmark FDA Approval for Lenmeldy™, Pioneering Gene Therapy for Early-onset Metachromatic Leukodystrophy

Orchard Therapeutics, now under the stewardship of Kyowa Kirin, announces a historic milestone as the U.S. Food and Drug Administration (FDA) grants approv...

March 19, 2024 | Tuesday | News
Optinose's XHANCE Receives FDA Approval for Chronic Sinusitis Treatment, Marking a Milestone in Patient Care

Optinose, a pharmaceutical company specializing in treatments for ear, nose, and throat (ENT) and allergy conditions, has achieved a significant milestone ...

March 18, 2024 | Monday | News
Biocon Biologics Gains Rights to Launch Stelara® Biosimilar in the US by 2025 Following Janssen Settlement

Biocon Biologics Ltd (BBL), a fully integrated global biosimilars company and subsidiary of Biocon Ltd (BSE code: 532523, NSE: BIOCON), announced...

March 04, 2024 | Monday | News
Atara Biotherapeutics Secures FDA Nod for Pioneering Lupus Nephritis Treatment

Atara Biotherapeutics, Inc. (Nasdaq: ATRA), a leader in T-cell immunotherapy, leveraging its novel allogeneic Epstein-Barr virus (EBV) T-cell platform to d...

March 01, 2024 | Friday | News
FDA-approved generic provides cost-effective option for treating cancer

Fresenius Kabi announced  it has introduced Cyclophosphamide for Injection, USP, a generic substitute for Cytoxan, for use in treating several forms o...

February 29, 2024 | Thursday | News
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

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