Showing posts with label FDA approval. Show all posts
Showing posts with label FDA approval. Show all posts
Monday, September 23, 2024

FDA Approves Libervant (diazepam) Buccal Film for the Treatment of Seizure Clusters in Pediatric Patients Ages 2-5 Years

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Aquestive Therapeutics, Inc. (NASDAQ: AQST) (“Aquestive” or the “Company”), a pharmaceutical company advancing medicines to bring meaningful...
Wednesday, September 18, 2024

FDA Approves Vafseo (vadadustat) for the Treatment of Anemia due to Chronic Kidney Disease in Adult Patients on Dialysis

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Akebia Therapeutics, Inc. (Nasdaq: AKBA), a biopharmaceutical company with the purpose to better the lives of people impacted by kidney dise...
Tuesday, September 17, 2024

FDA Approves Duvyzat (givinostat) for Duchenne Muscular Dystrophy

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Italfarmaco S.p.A.  announced today that the  U.S. Food and Drug Administration (FDA)  has approved Duvyzat™ (givinostat), a novel histone d...
Monday, September 16, 2024

FDA Approves Opsynvi (macitentan and tadalafil) for Adults with Pulmonary Arterial Hypertension

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Johnson & Johnson today announced that the U.S. Food and Drug Administration (FDA) has approved Opsynvi ®  – a single-tablet combination...
Friday, September 13, 2024

FDA Approves Rezenopy (naloxone hydrochloride) Nasal Spray for the Emergency Treatment of Opioid Overdose

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The U.S. Food and Drug Administration has approved Rezenopy (naloxone hydrochloride) nasal spray 10 mg for emergency treatment of known or s...
Thursday, September 12, 2024

FDA Approves Tryvio (aprocitentan) for the Combination Treatment of Resistant Hypertension

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Idorsia Pharmaceuticals U.S. Inc. announced the US Food and Drug Administration (FDA) approval of  Tryvio™ (aprocitentan) for the treatment ...
Tuesday, September 10, 2024

FDA Approves Xolremdi (mavorixafor) for Use in Patients with WHIM Syndrome

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X4 Pharmaceuticals (Nasdaq: XFOR), a company driven to improve the lives of people with rare diseases of the immune system, today announced ...

FDA Approves Exblifep (cefepime/enmetazobactam) for the Treatment of Complicated Urinary Tract Infections,

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Allecra Therapeutics (“Allecra”), a biopharmaceutical company developing novel therapies to combat antibiotic resistance, announced today th...
Friday, August 23, 2024

UCLA-led research results in FDA approval of 4-drug combination for frontline treatment of metastatic pancreatic cancer

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A four-drug chemotherapy regimen of irinotecan liposome (Onivyde) in combination with oxaliplatin, leucovorin, and fluorouracil—together ref...
Monday, August 12, 2024

FDA Approves Augtyro (repotrectinib) for the Treatment of Locally Advanced or Metastatic ROS1-Positive Non-Small Cell Lung Cancer (NSCLC)

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Bristol Myers Squibb (NYSE: BMY) announced  the U.S. Food and Drug Administration (FDA) approval of  Augtyro (repotrectinib) for the treatme...
Friday, August 2, 2024

FDA Approves Eohilia (budesonide oral suspension) for the Treatment of Eosinophilic Esophagitis

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 Takeda (TSE:4502/NYSE: TAK)   announced the U.S. Food and Drug Administration (FDA)   approval of Eohilia (budesonide oral suspension), the...
Thursday, August 1, 2024

FDA Approves Airsupra (albuterol/budesonide) Metered-Dose Inhaler to Reduce the Risk of Asthma Exacerbations

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Airsupra (albuterol/budesonide), formerly known as PT027, has been approved in the US for the as-needed treatment or prevention of bronchoco...