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FDA Grants Accelerated Approval for Vanrafia (atrasentan) for Proteinuria Reduction in Primary IgA Nephropathy
Basel, April 3, 2025 – Novartis today announced the US Food and Drug Administration (FDA) has granted accelerated approval for Vanrafia® (atrasentan),...
Bavarian Nordic Receives U.S. FDA Approval of Jynneos Freeze-Dried Smallpox and Mpox Vaccine
COPENHAGEN, Denmark, March 31, 2025 – Bavarian Nordic A/S (OMX: BAVA) today announced that the U.S. Food and Drug Administration (FDA) has approved...
FDA Approves Qfitlia (fitusiran) to Treat Hemophilia A or B With or Without Inhibitors
Paris, March 28, 2025. The US Food and Drug Administration (FDA) has approved Qfitlia (fitusiran), the first antithrombin-lowering (AT) therapy for routine...
Patient Navigation Program Increases Receipt of Colonoscopy
A patient navigation program is effective for increasing receipt of follow-up colonoscopy among adults with an abnormal stool test result, according to...
Public Lacks Knowledge About Dysphagia
There is a notable gap in public awareness and knowledge of dysphagia compared with other conditions, according to a study published online March 27 in Dysphagia. Sonja...
Postpartum Hormonal Contraceptives Tied to Higher Depression Risk
Use of hormonal contraceptives postpartum is associated with an increased risk for developing postpartum depression, according to a study published online...
Zoster Vaccine Has Dementia-Preventing or Delaying Effect
Zoster vaccination seems to have a dementia-preventing or dementia-delaying effect, according to a study published online April 2 in Nature. Markus Eyting,...
Two Louisiana Infants Die of Whooping Cough Amid Drop in Vaccinations
Health experts are warning that whooping cough, also known as pertussis, is making a dangerous comeback. Cases are rising across the country, and Louisiana...
How Cory Booker Prepped His Body To Break 25-Hour Senate Speech Record
U.S. Sen. Cory Booker stood on the Senate floor and spoke for 25 hours and 5 minutes this week, breaking the modern record for the longest Senate speech...
23 States Sue Over $12B in Public Health Cuts
A group of 23 states and Washington, D.C., is suing the U.S. Department of Health and Human Services (HHS) over a sudden cut of $12 billion in public health...
Longtime Head of 9/11 Health Program Let Go Amid Federal Job Cuts
The longtime leader of a federal health program for 9/11 survivors and first responders has been fired, worrying many advocates and lawmakers. The program...
Combination Immunotherapy Shrank a Variety of Metastatic Gastrointestinal Cancers
A new form of tumor infiltrating lymphocyte (TIL) therapy, a form of personalized cancer immunotherapy, dramatically improved the treatment’s effectiveness...
Monthly News Roundup - March 2025
FDA Approves Tremfya for Adults Patients with Active Crohn’s Disease In March, Johnson & Johnson announced the U.S. Food and Drug Administration...
Vanda Pharmaceuticals Announces the Submission of an NDA to the FDA for Bysanti for the Treatments of Acute Bipolar I Disorder and Schizophrenia
Vanda Pharmaceuticals Inc. (Vanda) (NASDAQ: VNDA) today announced that a New Drug Application (NDA) was submitted to the U.S. Food and Drug Administration...
Otsuka Files Biologics License Application (BLA) for Sibeprenlimab in the Treatment of Immunoglobulin A Nephropathy
PRINCETON, N.J. and TOKYO, JAPAN March 31, 2025 – Otsuka Pharmaceutical Development & Commercialization, Inc. and Otsuka Pharmaceutical Co.,...
New Drug May Cut Sudden Heart Risk by 94%
A new drug may help protect millions of people from heart attacks and strokes by lowering a little-known risk factor in the blood. The drug, made by Eli...
Primary Endpoint Met in Corcept’s Pivotal Phase 3 ROSELLA Trial of Relacorilant in Patients with Platinum-Resistant Ovarian Cancer
(BUSINESS WIRE)--Mar. 31, 2025-- Corcept Therapeutics Incorporated (NASDAQ: CORT), a commercial-stage company engaged in the discovery and development...
FDA Issues Complete Response Letter for Etripamil for PSVT
MONTREAL and CHARLOTTE, N.C., March 28, 2025 (GLOBE NEWSWIRE) -- Milestone® Pharmaceuticals Inc. (Nasdaq: MIST) today announced the U.S....
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Latest FDA New Drug Approvals
- Vanrafia Vanrafia (atrasentan) is an endothelin A receptor antagonist used for proteinuria reduction in primary immunoglobulin (IgA) nephropathy.
- Qfitlia Qfitlia (fitusiran) is an antithrombin-directed small interfering ribonucleic acid for the prophylactic treatment of people with hemophilia...
- Bomyntra Bomyntra (denosumab-bnht) is a RANK ligand (RANKL) inhibitor biosimilar to Xgeva (denosumab) for use in the prevention of skeletal-related...
Drugs in Development (Not yet approved)
- Yutrepia Yutrepia (treprostinil) is an inhaled dry powder formulation of treprostinil tentatively approved for the treatment of pulmonary arterial...