HUTCHMED's Savolitinib Advances for Expanded Approval in China, Promising New Hope for Lung Cancer Patients

  — If approved, would confirm 2021 conditional approval and expand indication to more patients — HUTCHMED (China) Lim...

March 28, 2024 | Thursday | 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
Biotech Lobbying Powerhouse BIO Ends Association with WuXi AppTec Amid Security Crackdown

Biotechnology Innovation Organization (BIO), a leading lobbying group in Washington, D.C., announced its decision to sever ties with WuXi AppTec, a Chinese...

March 15, 2024 | Friday | Reports
HHS Takes Decisive Action in Wake of Change Healthcare Cyberattack

  Recognizing the severity of the cyberattack, HHS has been actively engaged in regular discussions with UHG leadership, state partners, and a wide a...

March 07, 2024 | Thursday | 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
Pfizer's VELSIPITY® Receives European Commission Approval

Pfizer Inc. has announced that the European Commission (EC) has granted marketing authorization for VELSIPITY® (etrasimod) in the European Union, marki...

February 20, 2024 | Tuesday | 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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