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FDA Approves Zepbound (tirzepatide) as the First and Only Prescription Medicine for Moderate-to-Severe Obstructive Sleep Apnea in Adults with Obesity

Eli Lilly and Company (NYSE: LLY) today announced the U.S. Food and Drug Administration (FDA) approved Zepbound (tirzepatide) as the first and only prescription...

FDA Approves Tryngolza (olezarsen) to Reduce Triglycerides in Adults with Familial Chylomicronemia Syndrome

Ionis Pharmaceuticals, Inc. (Nasdaq: IONS) announced today that the U.S. Food and Drug Administration (FDA) has approved Tryngolza (olezarsen) as an adjunct...

FDA Approves Ryoncil (remestemcel-L-rknd) Mesenchymal Stromal Cell Therapy for Steroid-Refractory Acute Graft Versus Host Disease

Mesoblast Limited (Nasdaq:MESO; ASX:MSB), global leader in allogeneic cellular medicines for inflammatory diseases, today announced the Food and Drug Administration...

FDA Approves Ensacove (ensartinib) for ALK-Positive Locally Advanced or Metastatic Non-Small Cell Lung Cancer

On December 18, 2024, the Food and Drug Administration approved ensartinib (Ensacove, Xcovery Holdings, Inc.) for adult patients with anaplastic lymphoma...

FDA Approves Steqeyma (ustekinumab-stba), a Biosimilar to Stelara

Celltrion announced today that the U.S. Food and Drug Administration (FDA) has approved Steqeyma (ustekinumab-stba), a biosimilar to Stelara (ustekinumab),...

FDA Approves Crenessity (crinecerfont) for the Treatment of Children and Adults with Classic Congenital Adrenal Hyperplasia

Neurocrine Biosciences, Inc. (Nasdaq: NBIX) today announced the U.S. Food and Drug Administration has approved Crenessity (crinecerfont) capsules and oral...

FDA Approves Unloxcyt (cosibelimab-ipdl) for the Treatment of Cutaneous Squamous Cell Carcinoma

Checkpoint Therapeutics, Inc. ("Checkpoint") (Nasdaq: CKPT), today announced that the U.S. Food and Drug Administration ("FDA") has approved Unloxcyt (cosibelimab-ipdl)...

High Acceptance Seen for Liver Stiffness Test With Routine Retina Scan in T2DM

For individuals with type 2 diabetes, examination with vibration-controlled transient elastography (VCTE) alongside retina scanning has a high acceptance...

Sexual Minority Women Report Better Sexual Functioning Than Heterosexual Women

Sexual minority women (SMW) report better sexual functioning in midlife than their heterosexual peers, according to a study published online Dec. 17 in...

Cannabidiol Safe, May Lower Anxiety in Advanced Breast Cancer

For patients with advanced breast cancer and baseline clinical anxiety, cannabidiol (CBD) is safe and may reduce anxiety levels two to four hours after...

Children With Primary Ciliary Dyskinesia Likely to Have Asthma

Most children with likely primary ciliary dyskinesia (PCD) have asthma, according to a research letter published online Dec. 9 in JAMA Network Open. Joe...

Tainted Cucumbers Now Linked to 100 Salmonella Cases in 23 States

An outbreak of salmonella linked to cucumbers has now been tied to 100 known cases of the illness across 23 states, the U.S. Food and Drug Administration...

Check Your Pantry, Lay's Classic Potato Chips Recalled Due to Milk Allergy Risk

 Holy chip! Frito-Lay has issued a limited recall of select 13-oz bags of Lay’s Classic Potato Chips due to the potential presence of undeclared...

Norovirus Sickens Hundreds on Three Cruise Ships: CDC

Just over 300 people have been sickened in norovirus outbreaks on three different cruise ships in December, new government data shows. This is the only...

What's the Link Between Memory Problems and Sexism?

Sexism is incredibly toxic to women’s lives, resulting in lower pay, fewer career opportunities, worse health care and a greater risk of violence. It...

U.S. Food and Drug Administration Issues Complete Response Letter for the Glepaglutide New Drug Application for the Treatment of Short Bowel Syndrome

Copenhagen, Denmark, December 19, 2024 – Zealand Pharma A/S (Nasdaq: ZEAL) (“Zealand”) (CVR-no. 20045078), a biotechnology company focused...

Nurix Therapeutics Receives U.S. FDA Fast Track Designation for NX-5948 for the Treatment of Relapsed or Refractory Waldenstrom’s Macroglobulinemia

SAN FRANCISCO, Dec. 19, 2024 (GLOBE NEWSWIRE) -- Nurix Therapeutics, Inc. (Nasdaq: NRIX), a clinical stage biopharmaceutical company...

Sapience Therapeutics Receives FDA Orphan Drug Designation for ST316, a First-in-Class β-catenin Antagonist, for the Treatment of Familial Adenomatous Polyposis (FAP)

TARRYTOWN, N.Y., December 19, 2024 – Sapience Therapeutics, Inc., a clinical-stage biotechnology company focused on the discovery and development...

With Correct Measurements, Wine Really May Protect Heart

A little wine every day can protect your heart health, a new study suggests. People who drank half to one glass of wine a day had a 50% lower risk of...

Tonix Pharmaceuticals Announces FDA Acceptance of the New Drug Application (NDA) for TNX-102 SL for Fibromyalgia

Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP) (Tonix or the Company), today announced that the U.S. Food and Drug Administration (FDA) has accepted...

Shoppers-Plaza Issues Voluntary Nationwide Recall of Fouzee Sugarlin Herbal Formula Due To Presence Of Undeclared Metformin And Glyburide

December 16, 2024 – Los Angeles, California - Shoppers-Plaza is voluntarily recalling all lots of Fouzee Sugarlin Herbal Formula capsules to the...

FDA Adds Boxed Warning to Veozah (fezolinetant) to Highlight the Known Risk of Rare But Serious Liver Injury

Update: December 16, 2024FDA adds a Boxed Warning, our most prominent warning, to highlight the known risk of rare but serious liver injury associated...

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Recently Added

Recently added consumer and prescribing information: Ensacove, Steqeyma, Yesintek, Revuforj, Danziten, Aucatzyl, Emrosi, Imuldosa, Hympavzi, Flyrcado

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Latest FDA New Drug Approvals

  • Tryngolza Tryngolza (olezarsen) is an APOC-III-directed antisense oligonucleotide indicated as an adjunct to diet to reduce triglycerides in adults...
  • Ryoncil Ryoncil (remestemcel-L-rknd) is an allogeneic bone marrow-derived mesenchymal stromal cell therapy indicated for the treatment of...
  • Ensacove Ensacove (ensartinib) is an anaplastic lymphoma kinase (ALK) inhibitor for the treatment of ALK-positive non-small cell lung cancer.

More FDA approvals

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