Bristol Myers Squibb Advances Immuno-Oncology Footprint with New Opdivo Indications

In the U.S., FDA approval establishes Opdivo in combination with doxorubicin, vinblastine and dacarbazine (AVD) as the first immunotherapy combination ...

March 24, 2026 | Tuesday | News
Belief BioMed’s Gene Therapy BBM-H901 Gains Macao Approval for Hemophilia B

Belief BioMed  announced that BBM-H901 (generic name: Dalnacogene Ponparvovec Injection), has been officially approved by the Pharmaceutical Adminis...

March 23, 2026 | Monday | News
Sanofi’s Venglustat Secures FDA Breakthrough Therapy Designation for Type 3 Gaucher Disease

Sanofi’s venglustat earns Breakthrough Therapy designation in the US for type 3 Gaucher disease The US Food and Drug Administration (FDA...

March 19, 2026 | Thursday | News
Novartis’ Cosentyx Approved by FDA for Adolescents with Moderate to Severe Hidradenitis Suppurativa

Cosentyx is the only IL-17A inhibitor approved for this population, and the first differentiated mechanism in nearly a decade1-3  HS often e...

March 16, 2026 | Monday | News
FDA Grants Fast Track Designation to Quoin’s QRX003 Lotion for Netherton Syndrome

— Fast Track Designation facilitates development and expedites regulatory review of therapies addressing serious conditions with significant unmet ...

March 13, 2026 | Friday | News
CMIC Co., Ltd. Partners with Bluenote to Deploy Agentic AI Across Clinical Development

CMIC Co., Ltd., a contract research organization (CRO) jointly owned by Blackstone and CMIC HOLDINGS Co. Ltd.,  announced a strategic partnership with...

March 11, 2026 | Wednesday | News
Halozyme Therapeutics, Inc and Johnson & Johnson Secure FDA Approval for TECVAYLI® Plus DARZALEX FASPRO® in RRMM

Halozyme Therapeutics, Inc. (NASDAQ: HALO) (Halozyme) announced that Johnson & Johnson has received approval from the U.S. Food and Drug Administrati...

March 09, 2026 | Monday | News
Bayer Secures FDA Clearance Expanding Capabilities of MEDRAD MRXperion MR Injection System

Clearance reinforces Bayer’s continued commitment to dependable, integrated radiology solutions Expanded Tesla compatibility captures low- to ...

March 06, 2026 | Friday | News
Cipla USA Inc. Launches Generic Saxenda® in the U.S., Expanding Access to GLP-1 Weight Management Therapy

Cipla USA Inc. the wholly owned subsidiary of Cipla Limited(BSE: 500087; NSE: CIPLA; and hereafter referred to as "Cipla")announced the launch of Li...

March 03, 2026 | Tuesday | News
Aardvark Therapeutics Voluntarily Pauses Phase 3 HERO Trial of ARD-101 in Prader-Willi Syndrome

Aardvark Therapeutics, Inc. (Aardvark) (Nasdaq: AARD), a clinical-stage biopharmaceutical company focused on developing novel, small-molecule therapeutic...

March 02, 2026 | Monday | News
Johnson & Johnson Files for FDA Approval of IMAAVY® in Warm Autoimmune Hemolytic Anemia

Johnson & Johnson announced the submission of a supplemental Biologics License Application (sBLA) to the U.S. Food and Drug Administration (FDA), see...

March 26, 2026 | Thursday | News
Lupin Expands U.S. CNS Portfolio with FDA Approval of Brivaracetam Oral Solution

Global pharma major Lupin Limited (Lupin) (BSE: 500257) (NSE: LUPIN) (REUTERS: LUPIN.BO) (BLOOMBERG: LPCIN)   announced that it has received ap...

February 26, 2026 | Thursday | News
Dr. Reddy’s Advances Biosimilar Pipeline with FDA Review Acceptance for DRL_AB

Dr. Reddy’s Laboratories Ltd. (BSE: 500124, NSE: DRREDDY, NYSE: RDY, NSEIFSC: DRREDDY, along with its subsidiaries together referred to as “D...

February 24, 2026 | Tuesday | News
Primera Analytical Solutions Accelerates FDA-Compliant Digital Transformation with Cenevo’s Labguru Platform

Primera Analytical Solutions (Primera), an FDA-compliant analytical Contract Research Organization (CRO), has selected Cenevo’s  Labguru electro...

February 20, 2026 | Friday | News

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