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FDA Approves Omlyclo (omalizumab-igec), an Interchangeable Biosimilar to Xolair

Celltrion today announced the U.S. Food and Drug Administration (FDA) approved Omlyclo® (omalizumab-igec) as the first and only biosimilar...

scPharmaceuticals Announces FDA Approval of Supplemental New Drug Application Expanding the Furoscix Indication to Include the Treatment of Edema in Patients with Chronic Kidney Disease

scPharmaceuticals Inc. (Nasdaq: SCPH) (the “Company”), a pharmaceutical company committed to revolutionizing cardiorenal healthcare through...

FDA Approves Encelto (revakinagene taroretcel-lwey) for the Treatment of Macular Telangiectasia Type 2 (MacTel)

(BUSINESS WIRE)--Neurotech Pharmaceuticals, Inc., a private biotech company focused on developing transformative therapies for chronic eye diseases, announced...

ARS Pharmaceuticals Announces FDA Approval of neffy 1 mg (epinephrine nasal spray) for Type I Allergic Reactions in Pediatric Patients

ARS Pharmaceuticals, Inc. (Nasdaq: SPRY), a biopharmaceutical company dedicated to empowering at-risk patients and caregivers to better protect themselves...

FDA Approves Osenvelt (denosumab-bmwo), a Biosimilar to Xgeva

Celltrion today announced that the U.S. Food and Drug Administration (FDA) has approved Osenvelt (CT-P41, denosumab-bmwo), a biosimilar referencing Xgeva...

FDA Approves Stoboclo (denosumab-bmwo), a Biosimilar to Prolia

Celltrion today announced that the U.S. Food and Drug Administration (FDA) has approved Stoboclo (CT-P41, denosumab-bmwo), a biosimilar referencing Prolia...

CagriSema Demonstrates Superior Weight Loss in Adults with Obesity or Overweight and Type 2 Diabetes in the REDEFINE 2 Trial

Bagsværd, Denmark, 10 March 2025 – Today, Novo Nordisk announced headline results from REDEFINE 2, a phase 3 trial in the global REDEFINE programme....

1990 to 2023 Saw 14 Percent Decrease in Actual Number of U.S. Births

From 1990 to 2023, there was a decrease in the number of births and in general and total fertility rates (GFRs and TFRs), according to the March 6 National...

Shift Work, Night Work Increase Risk for Common Cold in Nurses

Shift work and night work are associated with an increased risk for the common cold and several other infections among nurses, according to a study published...

6.95 Percent of U.S. Adults Have Been Present at Scene of Mass Shooting

Overall, 6.95 percent of U.S. adults report being present at the scene of a mass shooting, and 2.18 percent sustained physical injuries during these incidences,...

Americans Borrowed $74 Million in 2024 to Cover Medical Costs

Thirty-one million people, or 12 percent of the U.S. adult population, borrowed $74 million last year to help pay medical costs for themselves or a family...

Icotrokinra Meets Primary Endpoint of Clinical Response in Ulcerative Colitis Study and Shows Potential to Transform the Treatment Paradigm for Patients

SPRING HOUSE, Pa. (March 10, 2025) – Johnson & Johnson (NYSE: JNJ) today announced positive topline results from ANTHEM-UC, a Phase 2b study...

Mutational Signatures Tied to Haloalkane Exposure Are Enriched in Firefighters

In a study published online March 10 in Cancer, authors identified gliomas with mutational signatures associated with haloalkane exposure in individuals...

New Medicare Rules Aim to Cut Radiation Exposure From CT Scans

Hospitals and imaging centers are now required to track and report radiation exposure from CT scans under new Medicare regulations. The rules, which began...

CDC to Study Vaccines and Autism, Despite Much Research Showing No Link

The U.S. Centers for Disease Control and Prevention (CDC) is preparing to study whether vaccines are linked to autism -- despite overwhelming scientific...

Common Vaginal Infection Should Be Treated as an STI, Study Says

A common vaginal infection that affects nearly 1 in 3 women worldwide should be reclassified as a sexually transmitted infection (STI), a new study suggests. Bacterial...

Butter Is A Deadly Delight, Study Says

It’s a cook’s maxim that everything’s better with butter. Except your health, a new study suggests. People who eat loads of butter...

Capricor Therapeutics Announces FDA Acceptance and Priority Review of its Biologics License Application for Deramiocel to Treat Duchenne Muscular Dystrophy

Capricor Therapeutics (NASDAQ: CAPR), a biotechnology company developing transformative cell and exosome-based therapeutics for the treatment of rare diseases,...

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Latest FDA New Drug Approvals

  • Omlyclo Omlyclo (omalizumab-igec) is an anti-IgE antibody interchangeable biosimilar to Xolair for the treatment of asthma, chronic rhinosinusitis...
  • Encelto Encelto (revakinagene taroretcel-lwey) is an allogeneic encapsulated cell-based gene therapy indicated for the treatment of adults with...
  • Osenvelt Osenvelt (denosumab-bmwo) is a RANK ligand (RANKL) inhibitor biosimilar to Xgeva (denosumab) for use in the prevention of skeletal-related...

More FDA approvals

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...

More drugs in development