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U.S. FDA Approves Subcutaneous Administration of Takeda’s Entyvio (vedolizumab) for Maintenance Therapy in Moderately to Severely Active Crohn’s Disease
OSAKA, Japan April 19, 2024 and CAMBRIDGE, Massachusetts, April 18, 2024 – Takeda (TSE:4502/NYSE:TAK) today announced that the U.S. Food and Drug...
FDA Approves Lumisight (pegulicianine) Optical Imaging Agent to Illuminate Residual Breast Cancer Post-Lumpectomy
(BUSINESS WIRE) April 18, 2024 --Lumicell, Inc., a privately held company focused on developing innovative fluorescence-guided imaging technologies for...
FDA Approves Genentech's Alecensa as First Adjuvant Treatment for People With ALK-Positive Early-Stage Lung Cancer
April 18, 2024 -- Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), announced today that the U.S. Food and Drug Administration...
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:...
Pandemic Had Modest Effect on Early Childhood Development Milestones
Modest changes were seen in early childhood development milestone achievement during the COVID-19 pandemic, according to a study published online April...
Higher SaFETy Scores ID Increased Prevalence of Firearm Violence
The SaFETy score, a clinical screening tool specific to firearm violence, can identify young adults with past six-month firearm violence, according to...
Hospital Mortality Lower for Patients Treated by Female Physicians
Patients have lower hospital mortality and readmission rates when treated by female physicians, with a larger benefit observed for female patients, according...
Alecensa Approved as First and Only ALK Inhibitor for Non-Small Cell Lung Cancer
The U.S. Food and Drug Administration has approved Alecensa (alectinib) as adjuvant treatment following tumor resection in patients with anaplastic lymphoma...
Pandemic Had Only Minor Effect on Young Kids' Development
The pandemic caused only “modest” delays in developmental milestones for infants and toddlers, a new study has found. Previous research has...
Few Young Adults Could Administer Naloxone to Reverse Fentanyl Overdose
Even though fentanyl-linked fatal overdoses are soaring among young adults, a new survey of American college students found that just 1 in 7 knew how to...
A-Fib More Common in Middle-Aged Folk Than Thought
The dangerous heart rhythm disorder called atrial fibrillation is becoming more common in middle-aged people, a new study warns. More than a quarter of...
What Folks Consider 'Old Age' Is Getting Older
People’s idea of “old age” is aging itself, with middle-aged folks and seniors believing that old age starts later in life than did peers...
FDA Approves Clinical Trial for GFH925 Monotherapy in Phase III Registrational Study Treating Metastatic Colorectal Cancer
SHANGHAI, April 19, 2024. GenFleet Therapeutics, a clinical-stage biotechnology company focusing on cutting-edge therapies in oncology and immunology,...
Abeona Therapeutics Provides Regulatory Update on Pz-cel
Abeona Therapeutics Inc. (Nasdaq: ABEO) today announced a regulatory update for prademagene zamikeracel (pz-cel). The U.S. Food and Drug Administration...
Doctors Underutilize Next-Gen Antibiotics to Fight Resistant Infections in U.S. Hospitals
Despite Food and Drug Administration (FDA)-approval of seven next-generation antibiotics to fight infections caused by resistant “gram-negative”...
FDA Requires Boxed Warning for T Cell Malignancies Following Treatment with BCMA-Directed or CD19-Directed Autologous CAR T Cell Immunotherapies
In November 2023, the Food and Drug Administration (FDA) posted a safety communication to provide information about reports of T cell malignancies including...
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...
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Recently added consumer and prescribing information: Xromi, Risvan, Voydeya, Winrevair, Pemgarda, Tryvio, Edurant and Edurant Ped, Tevimbra, Rezdiffra, Tyenne
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Latest FDA New Drug Approvals
- Lumisight Lumisight (pegulicianine) is an optical imaging agent for the detection of residual cancerous tissue during breast cancer surgery.
- 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...
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.