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FDA Approves Pivya (pivmecillinam) for the Treatment of Uncomplicated Urinary Tract Infections

Today, the U.S. Food and Drug Administration approved Pivya (pivmecillinam) tablets for the treatment of female adults with uncomplicated urinary tract...

FDA Grants Accelerated Approval for Ojemda (tovorafenib) for Relapsed or Refractory BRAF-altered Pediatric Low-Grade Glioma

Day One Biopharmaceuticals, Inc. (Nasdaq: DAWN) (“Day One” or the “Company”), a commercial-stage biopharmaceutical company dedicated...

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...

Two-Thirds of Survivors of the Most Severe COVID-19 Face Impairment at One Year

Nearly two-thirds of survivors of severe COVID-19 discharged to long-term acute care hospitals have persistent impairments at one year, according to a...

Births in the United States Declined in 2023

In 2023, birth rates in the United States were down, according to an April Vital Statistics Rapid Release provisional report, a publication from the National...

Serum Biomarkers Predict Knee OA Before Radiographic Abnormalities

Serum biomarkers can predict knee osteoarthritis before radiographic abnormalities, according to a study published in the April 26 issue of Science Advances....

Antenatal Corticosteroids Do Not Negatively Impact Offspring

Administration of antenatal corticosteroids to persons at risk for late preterm delivery is not associated with adverse childhood neurodevelopmental outcomes...

USDA Gets Tougher on Salmonella in Raw Breaded Chicken Products

The U.S. Department of Agriculture is clamping down on salmonella bacteria found in breaded, stuffed raw chicken products, with the agency issuing a final...

'Drug Take Back Day' is Saturday: Check for Leftover Opioids in Your Home

Each year, thousands of Americans head home after a surgery clutching prescription opioids to help ease post-surgical pain. Trouble is, most won't use...

Fragments of Bird Flu Virus Found in 1 in 5 Milk Samples

Bits of bird flu virus have been discovered in roughly 20% of retail milk samples tested in a national survey, the U.S. Food and Drug Administration said...

Clients Got HIV Through 'Vampire Facial' Microneedling Treatments

Between 2018 and the spring of 2023, a cluster of clients who had gotten 'vampire facial' microneedling skin treatments at a New Mexico spa were diagnosed...

Clinical Study Identifies Personalized Treatment Options for Metastatic Non-Small Cell Lung Cancer With Plasma Proteome Testing

FORT MYERS, Fla., April 25, 2024. Florida Cancer Specialists & Research Institute, LLC (FCS) medical oncologist and hematologist Ernesto Bustinza-Linares,...

Gene-Based Therapy Restores Cellular Development and Function in Brain Cells From People With Timothy Syndrome

In a proof-of-concept study, researchers demonstrated the effectiveness of a potential new therapy for Timothy syndrome, an often life-threatening and...

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...

Dr. Reddy’s Issues Voluntary Nationwide Recall of Sapropterin Dihydrochloride Powder for Oral Solution 100 mg Due to Sub-Potency

Hyderabad India and Princeton, NJ, US; April 23, 2024 – Dr. Reddy's Laboratories Ltd. today announced that it is voluntarily recalling six (6) lots...

Stop Clopez Corp. Issues Voluntary Worldwide Recall of Schwinnng Capsules Due to the Presence of Undeclared Nortadalafil

April 22, 2024– Hollywood, FL, US, Stop Clopez Corp. is voluntarily recalling one lot of Schwinnng capsules to the consumer level. FDA analysis has...

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...

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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

  • Pivya Pivya (pivmecillinam) is a penicillin class antibacterial for use in the treatment of uncomplicated urinary tract infections.
  • Ojemda Ojemda (tovorafenib) is a type II pan-RAF kinase inhibitor for the treatment of pediatric low-grade glioma.
  • Anktiva Anktiva (nogapendekin alfa inbakicept-pmln) is a first-in-class interleukin-15 superagonist for use in combination with Bacillus...

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...
  • Libervant Libervant (diazepam) is a buccal film formulation of the approved benzodiazepine diazepam in development for the management of seizure clusters.

More drugs in development