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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...
Bristol Myers Squibb’s CAR T Cell Therapy Breyanzi Approved by the U.S. Food and Drug Administration for Relapsed or Refractory Follicular Lymphoma
(BUSINESS WIRE) May 15, 2024 -- Bristol Myers Squibb (NYSE: BMY) today announced the U.S. Food and Drug Administration (FDA) has granted accelerated approval...
Recommendations Developed for People With HIV Wanting to Breastfeed
In an American Academy of Pediatrics clinical report published online May 20 in Pediatrics, recommendations are presented for breastfeeding among people...
Prehospital Reduction in BP Does Not Improve Stroke Outcomes
For patients with acute stroke, prehospital reduction in blood pressure does not affect functional outcomes, according to a study published online May...
Individuals With BAP1 Have High Rate of Nail Abnormalities
Individuals with BRCA1-associated protein (BAP1) have a high rate of nail abnormalities consistent with onychopapillomas, according to a study published...
Bisoprolol Does Not Reduce Exacerbations in At-Risk COPD Patients
For patients with chronic obstructive pulmonary disease (COPD), bisoprolol does not reduce the number of self-reported exacerbations treated with oral...
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...
In a Shift, Pediatricians' Group Says Breastfeeding Safe When HIV-Positive Mom Is Properly Treated
The nation’s top pediatrics group has reversed its decades-old position on HIV-positive mothers breastfeeding their infants.The American Academy of Pediatrics...
Fertility Treatments Safe for Breast Cancer Survivors With Cancer-Linked Genes
Fertility treatments such as in vitro fertilization (IVF) and other methods don't boost the odds for tumor recurrence in young women who've survived breast...
New Study Shows Novel Neuroprotective Drug Candidate Meets Primary Endpoint in Patients with Mild to Moderate Alzheimer's Disease
NEW YORK, May 17, 2024. A study published today in Nature Medicine found that a novel neuroprotective drug candidate, LM11A-31, was safe and well-tolerated...
Investigational Seladelpar Demonstrates Significant Improvements in Liver Disease Progression and Reduced Itching in Primary Biliary Cholangitis
(BUSINESS WIRE) May 18, 2024 -- Gilead Sciences, Inc. (Nasdaq: GILD), following the recent acquisition of CymaBay Therapeutics, Inc., today announced...
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...
Ascendis Pharma Announces Extension of U.S. Food and Drug Administration Review Period for TransCon PTH for Adults with Hypoparathyroidism
Ascendis Pharma A/S (Nasdaq: ASND) today announced that the U.S. Food and Drug Administration (FDA) notified the Company that information submitted in...
FDA Safety Communication: Do Not Use Cue Health’s COVID-19 Tests Due to Risk of False Results
The U.S. Food and Drug Administration (FDA) is warning home test users, caregivers, and health care providers not to use Cue Health’s COVID-19 Tests...
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Recently added consumer and prescribing information: Myhibbin, Rezenopy, Libervant, Beqvez, Xolremdi, Pivya, Xromi, Risvan, Voydeya, Winrevair
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Latest FDA New Drug Approvals
- Imdelltra Imdelltra (tarlatamab-dlle) is a first-in-class, bispecific delta-like ligand 3 (DLL3)-directed CD3 T cell engager indicated for the...
- Myhibbin Myhibbin (mycophenolate mofetil) is an antimetabolite immunosuppressant used for the prophylaxis of organ rejection.
- Libervant Libervant (diazepam) is a buccal film formulation of the benzodiazepine diazepam used to treat children aged 2 to 5 years with seizure clusters.
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...
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