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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...

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...

1 in 4 Parents Say Their Teen Drinks Caffeine Daily

Many teens are spending their days buzzed on caffeine, with their parents mostly unaware of the potential risks, a new national poll says.A quarter of...

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...

Half of Native Americans Older Than 70 Years May Have Cognitive Impairment

More than half of Native Americans aged 70 years and older have cognitive impairment, according to a study published online May 15 in Alzheimer's...

Use of Electronic Cigarettes Tied to Earlier Age at Onset of Adult Asthma

Past 30-day electronic nicotine delivery systems (ENDS) use among adults is associated with earlier ages of asthma onset, according to a study published...

Vitamin D Deficiency Tied to Worse Outcomes With Early Kidney Disease

Vitamin D deficiency is associated with increased risks for cardiovascular mortality and chronic kidney disease (CKD) progression in patients with early-stage...

Slight Body Mass Gains in Middle Age May Cut Later Fracture Risk

People whose body mass index (BMI) slightly increases from normal weight to low-level overweight during 30 years of middle adulthood have a lower risk...

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.

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...

More drugs in development