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ANI Pharmaceuticals Announces FDA Approval for Expansion of Iluvien Label

ANI Pharmaceuticals, Inc. (Nasdaq: ANIP) (ANI or the Company) today announced that the U.S. Food and Drug Administration (FDA) has approved an expanded...

Early Detection of Colon Cancer Is Critical for Women

Colon cancer is one of the most dangerous cancers affecting women today.  Despite its impact, many women miss early warning signs, mistaking them...

Scientists Develop Rapid Bird Flu Detector for Airborne Test

Scientists have created a handheld sensor that can quickly detect bird flu (H5N1) in the air, potentially stopping outbreaks before they spread. Research...

KRRO-110 Receives Orphan Drug Designation from U.S. FDA for Alpha-1 Antitrypsin Deficiency

Korro Bio, Inc. (Korro) (Nasdaq: KRRO), a clinical-stage biopharmaceutical company focused on developing a new class of genetic medicines based on editing...

Sanofi Adopts FDA-Selected Flu Strains to Ensure Readiness for the 2025-26 Flu Season

Sanofi announced today the immediate adoption of influenza strains selected by the US Food and Drug Administration (FDA) to advance the manufacturing and...

Parents Feel They Are Lacking Information About Bird Flu

Only 43 percent of parents report they are able to find accurate and current information on avian influenza A(H5N1), commonly known as bird flu, according...

AAD: Maintenance of Low Eczema Activity Seen After About 80 Days Off Tapinarof

Patients with atopic dermatitis (AD) who achieve completely clear skin with tapinarof (Vtama) cream maintain low disease activity after about 80 days off...

COVID-19 Vaccination Not Linked to Major Structural Birth Defects

COVID-19 vaccination in early pregnancy (≤20 weeks of gestation) is not associated with increased prevalence of major structural birth defects, according...

Roflumilast Cream 0.05 Percent Safe, Effective in Young Children With Eczema

Once-daily roflumilast cream 0.05 percent is safe and effective for atopic dermatitis (AD) in patients ages 2 to 5 years, according to a study published...

Abnormal Uterine Bleeding Linked to Fatigue in Menopause Transition

Prolonged (PMB) or heavy (HMB) menstrual bleeding during the menopause transition (MT) is associated with experiencing certain symptoms of fatigue, according...

Harvard Profs Sue Trump Administration Over Removal of LGBTQ Research From Website

Two Harvard medical school professors are suing the Trump administration, arguing that their research was unfairly removed from a government-run website. Their...

FDA Advises Consumers Not to Inhale Nitrous Oxide Products

FDA advises consumers not to inhale nitrous oxide products from any size canisters, tanks, or chargers. These products are marketed as both unflavored...

Dr. Reddy’s Issues a Nationwide Recall of Levetiracetam in 0.75% Sodium Chloride Injection 1,000 mg/100 mL, in the U.S., Due to Mislabeling of Infusion Bag

Dr. Reddy’s Laboratories Ltd. (BSE: 500124, NSE: DRREDDY, NYSE: RDY, NSEIFSC: DRREDDY; along with its subsidiaries together referred to as “Dr....

Limited Number of Voluntary Recalls Initiated after FDA Testing of Acne Products for Benzene

FDA is alerting the public and industry to the results of new agency testing of 95 acne products containing benzoyl peroxide for possible benzene contamination....

Hormone Therapy For Menopause Linked To Alzheimer's Hallmark

Hormone replacement therapy during menopause appears to be linked to a toxic brain protein that’s a hallmark of Alzheimer’s disease. Women...

Voluntary Lot Withdrawals of Immune Globulin Intravenous (IGIV) and Immune Globulin Subcutaneous (IGSC) Due to Increased Reports of Allergic/Hypersensitivity Reactions

As a precautionary measure, the following lots of Immune Globulin Intravenous (IGIV) and Immune Globulin Subcutaneous (IGSC) have been voluntarily withdrawn...

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Recently added consumer and prescribing information: Opdivo Qvantig, Alyftrek, Crenessity, Ensacove, Steqeyma, Yesintek, Revuforj, Danziten, Aucatzyl, Emrosi

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Latest FDA New Drug Approvals

  • Omlyclo Omlyclo (omalizumab-igec) is an anti-IgE antibody interchangeable biosimilar to Xolair for the treatment of asthma, chronic rhinosinusitis...
  • Encelto Encelto (revakinagene taroretcel-lwey) is an allogeneic encapsulated cell-based gene therapy indicated for the treatment of adults with...
  • Osenvelt Osenvelt (denosumab-bmwo) is a RANK ligand (RANKL) inhibitor biosimilar to Xgeva (denosumab) for use in the prevention of skeletal-related...

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Drugs in Development (Not yet approved)

  • Yutrepia Yutrepia (treprostinil) is an inhaled dry powder formulation of treprostinil tentatively approved for the treatment of pulmonary arterial...

More drugs in development