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
Daiichi Sankyo and AstraZeneca's Datopotamab Deruxtecan BLA Accepted in U.S. for Advanced Nonsquamous NSCLC Treatment

Daiichi Sankyo (TSE: 4568) and AstraZeneca (LSE/STO/Nasdaq: AZN) have announced the acceptance of their Biologics License Application (BLA) for datopotamab...

February 19, 2024 | Monday | News
Japan first in the world to approve Dupixent® for chronic spontaneous urticaria (CSU)

  Approval based primarily on results from Phase 3 trial showing Dupixent significantly reduced itch compared to placebo CSU is the fifth approved...

February 16, 2024 | Friday | 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
Corvus Pharmaceuticals Receives Orphan Drug Designation for Soquelitinib in T Cell Lymphoma, Advances Towards Phase 3 Clinical Trial

Corvus Pharmaceuticals, Inc. (NASDAQ: CRVS), a distinguished player in the clinical-stage biopharmaceutical arena, has achieved a significant milestone wit...

February 12, 2024 | Monday | 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
NICE Issues Final Draft Guidance: ILUVIEN® Access Expanded for Diabetic Macular Edema Patients

NICE Final Draft Guidance recommends providing National Health System (NHS) patients with a phakic lens access to the only sustained-release treatment last...

February 08, 2024 | Thursday | 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
Junshi Biosciences Announces Toripalimab’s NDA Accepted by the Singapore Health Sciences Authority

Shanghai Junshi Biosciences Co., Ltd (“Junshi Biosciences”, HKEX: 1877; SSE: 688180), a leading innovation-driven biopharmaceutical company ded...

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

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