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FDA Approves Yesafili (aflibercept-jbvf), an Interchangeable Biosimilar to Eylea

The U.S. Food and Drug Administration (FDA) has approved Yesafili (aflibercept-jbvf), an interchangeable biosimilar to Eylea (aflibercept). Aflibercept...

FDA Approves Opuviz (aflibercept-yszy), an Interchangeable Biosimilar to Eylea

The U.S. Food and Drug Administration (FDA) has approved Opuviz (aflibercept-yszy), an interchangeable biosimilar to Eylea (aflibercept). Aflibercept...

FDA Approves Benlysta (belimumab) Autoinjector for Children with Systemic Lupus Erythematosus

GSK plc (LSE/NYSE: GSK) today announced that the US Food and Drug Administration (FDA) has approved a 200 mg subcutaneous route of administration of Benlysta...

FDA Grants Accelerated Approval for Imdelltra (tarlatamab-dlle) for the Treatment of Extensive-Stage Small Cell Lung Cancer

Amgen (NASDAQ:AMGN) today announced that the U.S. Food and Drug Administration (FDA) has approved Imdelltra™ (tarlatamab-dlle) for the treatment...

Zymfentra demonstrated long-term efficacy and safety profile of maintenance treatment for adults with moderately to severely active Crohn's disease and ulcerative colitis

JERSEY CITY, N.J., May 21, 2024. Celltrion USA announced today positive two-year results from the extended LIBERTY studies (LIBERTY-CD and LIBERTY-UC)...

No Association Found for Autoimmune Disease, Monoclonal Gammopathy

In a systematically screened population, there is no association between autoimmune disease and monoclonal gammopathy of undetermined significance (MGUS),...

Fezolinetant Safe, Effective for Moderate-to-Severe Menopause Hot Flashes

Fezolinetant is safe and effective for moderate-to-severe vasomotor symptoms (VMS), according to a study presented at the annual European Congress of Endocrinology,...

Arm Fat May Predict Spinal Fracture Risk

Arm fat may predict risk for spinal fracture, according to a study presented at the annual European Congress of Endocrinology, hosted by the European Society...

Long COVID Definitions, Care Models Are Evolving

Definitions of long COVID and care models are evolving, but considerable variability is seen in these models, according to a review published online May...

Tracking Exercise by Steps or Minutes? Study Finds Either Method Boosts Health

Some folks like to count their daily steps, while others prefer exercising for a certain amount of time during a day or a week. Luckily, either approach...

Stomach Paralysis Risk May Rise in People Taking Ozempic and Similar Drugs

New, real-world research confirms that the blockbuster weight-loss drugs that millions of Americans have been taking to shed pounds can trigger stomach...

Could Infertility Treatment Raise Postpartum Heart Risks?

Women treated for infertility were twice as likely as those who conceived naturally to be hospitalized with heart disease within a year of delivery, recent...

Blood Pressure Meds Raise Fracture Risks for Those in Nursing Homes

Blood pressure medications appear to more than double the risk of life-threatening bone fractures among nursing home residents, a new study warns. The...

Acetaminophen Shows Promise in Warding Off Acute Respiratory Distress Syndrome, Organ Injury in Patients with Sepsis

A National Institutes of Health (NIH)-supported clinical trial has found that intravenous acetaminophen reduced sepsis patients’ risk of having organ...

Leptospirosis: What Every Dog Owner Should Know

Mice, rats and other wildlife can pick up bacteria called leptospira from water or soil and excrete it in urine. If your dog contacts any soil or water...

Cross-Compatibility Issues with Autoinjector Devices Optional for Use with Glatiramer Acetate Injection

FDA is alerting patients, caregivers, and health care professionals of labeling updates for glatiramer acetate injection products. Updated labeling includes...

Plant-Based Diets Tied to Long-Term Health Benefits

Plant-based diets appear beneficial in lowering cardiometabolic risk factors, as well as cardiovascular diseases (CVDs), cancer risk, and mortality, according...

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Recently added consumer and prescribing information: Yesafili, Myhibbin, Rezenopy, Libervant, Beqvez, Xolremdi, Pivya, Xromi, Risvan, Voydeya

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Latest FDA New Drug Approvals

  • Yesafili Yesafili (aflibercept-jbvf) is a vascular endothelial growth factor (VEGF) inhibitor interchangeable biosimilar to Eylea indicated for the...
  • Opuviz Opuviz (aflibercept-yszy) is a vascular endothelial growth factor (VEGF) inhibitor interchangeable biosimilar to Eylea indicated for the...
  • Imdelltra Imdelltra (tarlatamab-dlle) is a first-in-class, bispecific delta-like ligand 3 (DLL3)-directed CD3 T cell engager indicated for the...

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Drugs in Development (Not yet approved)

  • Yutrepia Yutrepia (treprostinil) is an inhaled dry powder formulation of treprostinil for the treatment of pulmonary arterial hypertension (PAH) to...

More drugs in development