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FDA Approves Anktiva (nogapendekin alfa inbakicept-pmln) Plus BCG for BCG-Unresponsive Non-Muscle Invasive Bladder Cancer
ImmunityBio, Inc. (NASDAQ: IBRX), an immunotherapy company, today announced that the U.S. Food and Drug Administration (FDA) has approved Anktiva...
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:...
You Might Fare Better If Your Doctor Is Female, Study Finds
The gender of your doctor may play a part in your prognosis: New research shows that hospitalized patients are less likely to die if they’re treated...
CDC Launches Online 'Heat Forecaster' Tool as Another Summer Looms
Last summer was a record-breaker for heat emergencies, so the U.S. Centers for Disease Control and Prevention on Monday launched a new online heat forecaster...
Biden Administration Sets Nursing Home Staffing Minimums
The first-ever minimum staffing rule has been set for nursing homes, the Biden administration announced Monday.Central to the final rule, first proposed...
Neosporin Ointment in the Nose Might Be Potent Antibiotic
Want to prevent a respiratory infection?A fingerful of Neosporin antibiotic swabbed inside your nose might help you fight off a range of invading respiratory...
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...
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”...
Many Seniors Are Overmedicated, But ChatGPT Might Prevent That
AI could help doctors cut back on the bewildering variety of medications that seniors frequently are prescribed, a new study suggests. More than 40% of...
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...
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Latest FDA New Drug Approvals
- Anktiva Anktiva (nogapendekin alfa inbakicept-pmln) is a first-in-class interleukin-15 (IL-15) superagonist for use in combination with Bacillus...
- 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...
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.