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FDA Approves Selarsdi (ustekinumab-aekn), a Biosimilar to Stelara

(BUSINESS WIRE) April 16, 2024 --Alvotech (NASDAQ: ALVO) and Teva Pharmaceuticals, a U.S. affiliate of Teva Pharmaceutical Industries Ltd. (NYSE and TASE:...

Fasenra Approved for Treatment of Children Aged 6 to 11 with Severe Asthma

(BUSINESS WIRE) April 11, 2024 --AstraZeneca’s Fasenra® (benralizumab) is now approved by the US Food and Drug Administration (FDA) for add-on...

Xcopri (cenobamate) Receives FDA Approval for Alternate Methods of Administration That Include Crushed Tablet in Liquid Suspension Taken Orally or Through a Nasogastric Tube

 SK Life Science, Inc., a U.S. pharmaceutical company developing treatments that will change the future of central nervous system (CNS) disorders...

Check Your Fridge for Trader Joe's Fresh Basil, Linked to Salmonella

Fresh organic basil tainted with salmonella and sold by Trader Joe's in 29 states has sickened at least 12 people, according to an alert issued Wednesday...

Rising Number of Americans Sent to ERs Last Year During Heat Waves

As climate change threatens another long hot summer for Americans, new data shows last summer's record-breaking temperatures sent a rising number of people...

Ending Specialized Follow-Up Feasible in Asymptomatic, Low-Risk Leukemia

For select patients with asymptomatic, lower-risk chronic lymphocytic leukemia, ending specialized follow-up (sFU) is feasible and safe, according to a...

Pediatric Prescription-Opioid Overdose Visits to ED Increased in 2020

There was a substantial increase in pediatric prescription-opioid overdose emergency department visits from 2019 to 2020 in the United States, according...

Urine Test Might Help Men Skip Prostate Biopsies

When prostate cancer strikes, one question is paramount: Is it aggressive and requiring immediate treatment, or slow-growing and worthy of monitoring only? Right...

Tumor-Infiltrating Lymphocyte Abundance Prognostic in Early-Stage TNBC

For patients with early-stage triple-negative breast cancer (TNBC) who undergo surgery without chemotherapy, tumor-infiltrating lymphocyte (TIL) abundance...

Hemorrhagic Complications Rare After Cranial Epilepsy Surgery

Hemorrhagic complications are uncommon after cranial epilepsy surgery, according to a study published online April 12 in World Neurosurgery. Yong Liu,...

Report Finds High Levels of Pesticides in 20% of Fruits, Veggies

Nearly 20% of fresh, frozen and canned fruits and vegetables that Americans eat contain concerning levels of pesticides, a new report finds. Pesticides...

Walking Your Way to Better Health

Walking is one of the best exercises available to average folks, and it can be as easy as stepping out your front door, experts say. “It is something...

Counterfeit Versions of Botox Found in Multiple States

 FDA is alerting health care professionals and consumers that unsafe counterfeit versions of Botox (botulinum toxin) have been found in multiple states...

Arrivo Bio Initiates Large Phase 2b Clinical Trial in Major Depressive Disorder with Novel SIRT6 Activator SP-624

(BUSINESS WIRE) April 16, 2024 -- Arrivo BioVentures announced today a significant step forward in the fight against major depressive disorder (MDD) with...

TLX101-CDx (Pixclara) Granted FDA Fast Track Designation

 Telix today announces that the United States (U.S.) Food and Drug Administration (FDA) has granted Fast Track designation1 for the Company’s...

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Latest FDA New Drug Approvals

  • Selarsdi Selarsdi (ustekinumab-aekn) is a human interleukin-12 and -23 antagonist biosimilar to Stelara used for the treatment of plaque psoriasis...
  • Zevtera Zevtera (ceftobiprole medocaril) is a cephalosporin antibiotic for the treatment of bacteremia, acute bacterial skin and skin structure...
  • Risvan Risvan (risperidone) is an atypical antipsychotic indicated for the treatment of schizophrenia in adults.

More FDA approvals

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...
  • Libervant Libervant (diazepam) is a buccal film formulation of the approved benzodiazepine diazepam in development for the management of seizure clusters.

More drugs in development