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NICE Issues Final Draft Guidance: ILUVIEN® Access Expanded for Diabetic Macular Edema Patients

NICE Final Draft Guidance recommends providing National Health System (NHS) patients with a phakic lens access to the only sustained-release treatment last...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
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
HUTCHMED Granted ELUNATE® Approval in Hong Kong for Metastatic Colorectal Cancer Treatment

— First medicine approved under new “1+” mechanism by HKSAR Government, providing an important treatment option to patients in Hong Kong&...

January 30, 2024 | Tuesday | News
Glenmark Secures License Agreement for Envafolimab in Key Global Territories

Glenmark will be responsible for further developing, registering, and commercializing Envafolimab in India, Asia Pacific, Middle East...

January 29, 2024 | Monday | News
Celltrion USA Submits BLA for CT-P47, Biosimilar to ACTEMRA® (tocilizumab)

Celltrion USA  announced the submission of Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) for CT-P47, a biosimilar...

January 29, 2024 | Monday | News

Survey Box

Poll of the Week

Which area of biopharmaceutical research excites you the most?

× Please select an option to participate in the poll.
Processing...
× You have successfully cast your vote.
 {{ optionDetail.option }}  {{ optionDetail.percentage }}%
 {{ optionDetail.percentage }}% Complete
More polls
Stay Connected

Sign up to our free newsletter and get the latest news sent direct to your inbox

© 2024 Biopharma Boardroom. All Rights Reserved.

Show

Forgot your password?

Show

Show

Lost your password? Please enter your email address. You will receive a link to create a new password.

Back to log-in

Close