Adults Taking ORZEYFUL Experienced Significant and Meaningful Improvements Across the Full Range of Symptoms of Narcolepsy Type 1 (NT1) in Clinical T...
IQVIA (NYSE:IQV), a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healt...
Pluvicto now approved across PSMA+ metastatic prostate cancer, nearly doubling eligible patient population PSMAddition updated results show Pluvicto r...
-- Company received communication from FDA indicating that the PMA Supplement for idiopathic generalized epilepsy is not approvable in its current form...
FDA supports advancement of IVMED-85 into Phase 2 clinical development for pediatric myopia and provides alignment on key elements of the develop...
LEQEMBI IQLIK is a first-of-its-kind anti-amyloid treatment worldwide, offering at-home dosing for initiation and maintenance (approved in the U.S.)...
Sanofi’s subcutaneous Sarclisa Escena approved in the US as first anticancer treatment administered via on-body injector Sarclisa Escena admini...
Elevar Therapeutics, Inc., a majority-owned subsidiary of HLB Co., Ltd. and a fully integrated biopharmaceutical company dedicated to elevating treatment...
The US Food and Drug Administration (FDA) has expanded the approved indication for the Padcev (enfortumab vedotin) and Keytruda (pembrolizumab) combination...
- First and only approved genetic therapy to treat children as young as 2 years for both severe sickle cell disease and transfusion-dependent beta thal...
First approved treatment for thyroid eye disease (TED) with labeling that includes data for both active and chronic TED - - In two pivotal phase 3 cli...
Anivive converts Laverdia-CA1 to full FDA approval First FDA-approved product to validate Anivive's AI-enabled development model — from drug rep...
First and only CDK4/6 inhibitor approved for HR+ metastatic disease regardless of HER2 status Approval based on data from the collaborative Phase 3 ...
Pathway Labs announced its public launch of EchoNext, the world’s first FDA-approved AI detection tool that reads standard 12-lead electrocard...
© 2026 Biopharma Boardroom. All Rights Reserved.