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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...
Heritability for Autism Spectrum Disorder Varies for Males and Females
Heritability for autism spectrum disorder (ASD) varies for males and females, with higher heritability seen for males than females, according to a study...
Erenumab Effective, Safe for Rosacea-Linked Erythema, Flushing
The anticalcitonin gene-related peptide-receptor monoclonal antibody erenumab is effective and safe for treatment of rosacea-associated erythema and flushing,...
Rapid Transitions Seen From Neutral to Negative Emotional States in PTSD
Individuals with posttraumatic stress disorder (PTSD) undergo rapid transitions between neutral and negative emotional states, which are intensified by...
Study IDs Risk Factors for Extraintestinal Manifestations of IBD
Certain demographic, clinical, and genetic factors heighten the risk for extraintestinal manifestations (EIMs) with inflammatory bowel disease (IBD), according...
Most Homeless Americans Are Battling Mental Illness
Two-thirds of homeless people are experiencing some form of mental health disorder, a large, new review of data on the subject. The analysis found that...
FDA Recalls Heart Failure Devices Linked to Injuries and Deaths
Two implanted heart devices used by patients in end-stage heart failure are now under a strict U.S. Food and Drug Administration recall, after being tied...
COVID Does Not Spur Asthma in Kids, Study Finds
There’s no evidence that a COVID infection increases the risk of asthma in children, the first study to date on the subject finds. “We knew...
Weight-loss Drug Zepbound Eases Sleep Apnea in Company Trials
Zepbound, one of the wildly popular weight-loss drugs that millions of Americans now take, eased sleep apnea in obese adults in two company trials, drug...
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...
Pets Are Passing Drug-Resistant 'Superbugs' to Their Owners
Dogs and cats can pass antibiotic-resistant bacteria to their owners, raising concerns that household pets could be contributing to the world’s antibiotics...
Recently Added
Recently added consumer and prescribing information: Risvan, Voydeya, Winrevair, Pemgarda, Tryvio, Edurant and Edurant Ped, Tevimbra, Rezdiffra, Tyenne, Wyost
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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.
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.