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FDA Clears Investigational New Drug application for muscular dystrophy treatment

MINNEAPOLIS and ST. PAUL, Minn., July 17, 2024. Today, Myogenica, a University of Minnesota startup company, announced U.S. Food and Drug Administration...

Risankizumab Noninferior, Superior to Ustekinumab for Crohn Disease

For patients with moderate-to-severe Crohn disease, risankizumab is noninferior to ustekinumab for clinical remission at week 24 and is superior for endoscopic...

Ofatumumab Effective for MS Across Racial, Ethnic Subgroups

For patients with relapsing multiple sclerosis (RMS), ofatumumab is more effective than teriflunomide across racial and ethnic subgroups, according to...

Disparities in Post-Acute Stroke Care Depend on Insurance Status

Insurance-dependent racial and ethnic disparities and regional variations are seen in post-acute service utilization after stroke, according to a study...

Familial Recurrence Rate of Autism Spectrum Disorder 20.2 Percent

The familial recurrence rate of autism spectrum disorder (ASD) is 20.2 percent, which has not changed significantly from previous estimates, according...

Irregular Sleep Could Raise Your Odds for Diabetes

Sleeping long hours one night but only a few hours the next can be unhealthy, with a new study finding "irregular" sleep patterns could be a risk factor...

Feds Issue Warnings on 'Copycat' Delta-8 Products That Mimic Popular Foods

In a joint effort to curb the illegal sales of food products containing delta-8 THC, the U.S. Food and Drug Administration and the Federal Trade Commission...

Two Years Later, 988 Crisis Line Has Answered 10 Million Requests

Just two years after the launch of the nation's three-digit crisis hotline, more than 10 million calls, texts and chat messages have been fielded by counselors,...

Biking, Walking to Work a Game-Changer for Health

Bicycling to work can vastly improve your health and reduce your risk of death, a new study shows. People who bike commute have a 47% lower overall risk...

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...

Evommune Announces Positive Proof-of-Concept Clinical Trial Results for its MRGPRX2 Antagonist

PALO ALTO, Calf., July 16, 2024. Evommune, Inc., a clinical stage biotechnology company discovering and developing new ways to treat immune-mediated inflammatory...

FDA, FTC Continue Joint Effort to Protect Consumers Against Companies Illegally Selling Copycat Delta-8 THC Food Products

Today, the U.S. Food and Drug Administration and the Federal Trade Commission (FTC) issued warning letters to five companies for illegally selling copycat...

Eton Pharmaceuticals Announces FDA Acceptance of New Drug Application for ET-400 (Hydrocortisone Oral Solution)

Eton Pharmaceuticals, Inc (“Eton” or the “Company”) (Nasdaq: ETON), an innovative pharmaceutical company focused on developing...

Supercore Issues Voluntary Worldwide Recall of Hard Steel Capsules & Gold Hard Steel Plus Liquid Due to the Presence of Sildenafil and Acetaminophen

July 12, 2024 -- Supercore Products Group is voluntarily recalling of Hard Steel Capsules & Gold Hard Steel Plus Liquid to the consumer level. FDA...

Scientists Spot Cause of Lupus, Way to Reverse It

Lupus is caused by a specific defect in the immune system that can be reversed, potentially curing the autoimmune disorder, a new study claims. The disease...

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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

  • 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...
  • Nypozi Nypozi (filgrastim-txid) is a leukocyte growth factor biosimilar to Neupogen indicated for the treatment of neutropenia, neutropenia...

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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...

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