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FDA Approves Epysqli (eculizumab-aagh), a Biosimilar to Soliris

Samsung Bioepis Co., Ltd. announced today that the U.S. Food and Drug Administration (FDA) has approved the Biologics License Application (BLA) for Epysqli®...

Phathom Pharmaceuticals Announces FDA Approval of Voquezna (vonoprazan) Tablets for the Relief of Heartburn Associated with Non-Erosive GERD in Adults

Phathom Pharmaceuticals, Inc. (Nasdaq: PHAT), a biopharmaceutical company focused on developing and commercializing novel treatments for gastrointestinal...

Chemo Tied to Gut Microbiome Changes and Associated Cognitive Decline

Gut microbiome change is associated with cognitive decline during chemotherapy for patients with breast cancer, according to a study published online in...

Physical Activity Cuts Depression in People With Arthritis-Related Pain

Physical activity may be particularly important to manage depression symptoms in people with greater osteoarthritis-related pain, according to a study...

Guidelines Updated for Diagnosis, Management of Focal Liver Lesions

In a clinical guideline issued by the American College of Gastroenterology and published online in the July issue of The American Journal of Gastroenterology,...

Digoxin, Beta-Blockers Have Equivalent Effects on Heart Rate in A-Fib

For patients with atrial fibrillation, digoxin and beta-blockers have equivalent effects on heart rate at rest and on exertion, according to a study published...

U.S. Injuries From Electric Bikes, Scooters Are Soaring

More and more Americans who use "micromobility" transport, such as electric bikes and e-scooters, are motoring their way straight into the ER, new data...

Extra Money Keeps Poorer Americans Out of the ER, Study Finds

It's a simple strategy that could deliver powerful health dividends: New research shows that giving cash to poor people could help them stay out of the...

Marijuana Use While Pregnant Could Raise Odds for Complications

There's a slight but significant rise in dangerous obstetric complications for pregnant women who use marijuana, new research shows. Data from almost 317,000...

Study Finds Big Shift in Who's Using GLP-1 Meds Like Ozempic

The boom in using GLP-1 drugs like Ozempic to treat obesity has resulted in a bust regarding the drugs’ original purpose, which was to treat type 2 diabetes,...

TCBP Announces Dosing of 6th Patient in ACHIEVE Study in Patients with Acute Myeloid Leukemia

EDINBURGH, Scotland, July 22, 2024. TC BioPharm (Holdings) PLC ("TC BioPharm" or the "Company"), a clinical stage biotechnology company developing platform...

Hikma Pharmaceuticals USA Inc. Extends Voluntary Nationwide Recall of One Lot of Acetaminophen Injection, 1000mg/100mL (10mg/mL) Bags

London, July 22, 2024 – Hikma Pharmaceuticals PLC (Hikma, Group), today announces that its subsidiary Hikma Pharmaceuticals USA, Inc. is extending...

Dental Veneers: Everything You Need to Know

Looking for a brand new smile? Many people with chipped, worn or indelibly stained teeth may ponder the possibility of veneers. They're wholly cosmetic,...

Ionis completes enrollment in pivotal trial evaluating zilganersen in people living with Alexander disease

CARLSBAD, Calif., July 18, 2024. Ionis Pharmaceuticals, Inc. announced today that it has completed enrollment in the pivotal trial of zilganersen (ION373),...

Atara Biotherapeutics Announces U.S. FDA Acceptance and Priority Review of the Biologics License Application for Tabelecleucel (Tab-cel®) for the Treatment of Epstein-Barr Virus Positive Post-Transplant Lymphoproliferative Disease

(BUSINESS WIRE) July 17, 2024 -- Atara Biotherapeutics, Inc. (Nasdaq: ATRA), a leader in T-cell immunotherapy, leveraging its novel allogeneic Epstein-Barr...

Orexo Receives a Complete Response Letter Regarding the NDA for OX124, a High-Dose Naloxone Rescue Medication in Development for Opioid Overdose

Uppsala, Sweden – July 16, 2024 – Orexo AB (publ.), (STO:ORX) (OTCQX:ORXOY), today announces that the company has received a complete response...

Endo USA, Inc. Issues Recall of One Lot of Clonazepam Orally Disintegrating Tablets Due to Mislabeling: Incorrect Strength on Product Carton

MALVERN, PA, July 16, 2024 – Endo, Inc (OTCQX: NDOI) (“Endo”), announced today that one of its operating subsidiaries, Endo...

Lexicon Pharmaceuticals Receives December 20, 2024 PDUFA Goal Date for Sotagliflozin Type 1 Diabetes NDA Resubmission

The Woodlands, Texas, July 16, 2024 - Lexicon Pharmaceuticals, Inc. (Nasdaq: LXRX), today announced that the U.S. Food and Drug Administration...

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Recently added consumer and prescribing information: Pyzchiva, Ahzantive, Ohtuvayre, Sofdra, Yimmugo, Iqirvo, Rytelo, mRESVIA, Bkemv, Yesafili

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Latest FDA New Drug Approvals

  • Epysqli Epysqli (eculizumab-aagh) is a complement inhibitor biosimilar to Soliris for the treatment of paroxysmal nocturnal hemoglobinuria and...
  • Kisunla Kisunla (donanemab-azbt) is an amyloid beta-directed antibody indicated for the treatment of early symptomatic Alzheimer’s disease.
  • Ahzantive Ahzantive (aflibercept-mrbb) is a vascular endothelial growth factor (VEGF) inhibitor biosimilar to Eylea indicated for the treatment of...

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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