Agios Eyes Accelerated FDA Approval for Mitapivat in Sickle Cell Disease

Company has already submitted proposed confirmatory trial for FDA review, as required under accelerated approval pathway  Company plans to submit...

April 01, 2026 | Wednesday | News
Corcept’s Lifyorli™ Becomes First FDA-Approved SGRA for Platinum-Resistant Ovarian Cancer

Corcept Therapeutics Incorporated (NASDAQ: CORT), a commercial-stage company engaged in the discovery and development of medications to treat severe endo...

March 27, 2026 | Friday | News
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

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