FDA Approved Oncology Drugs 2023
Crown Bioscience
JUNE 6, 2024
In a significant development, the US Food and Drug Administration’s (FDA) Center for Drug Evaluation and Research (CDER) approved 55 new drugs in 2023.
FDA Approves New Kind of Drug for Schizophrenia
Drugs.com
SEPTEMBER 27, 2024
27, 2024 -- The first new type of medication in decades to help fight against schizophrenia was approved on Thursday by the U.S. Food and Drug Administration.Cobenfy (xanomeline/trospium chloride) could bring patients what they've. FRIDAY, Sept.
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FDA Approves New Drug to Treat Alzheimer's
Drugs.com
JULY 2, 2024
TUESDAY, July 2, 2024 -- A new drug to treat Alzheimer's disease was approved by the U.S. Food and Drug Administration on Tuesday.In clinical trials, donanemab (Kisunla) modestly slowed the pace of thinking declines among patients in the early.
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FDA Approves New Drug to Treat Alzheimer's, Kisunla
Drugs.com
JULY 2, 2024
TUESDAY, July 2, 2024 -- A new drug to treat Alzheimer's disease was approved by the U.S. Food and Drug Administration on Tuesday. In clinical trials, donanemab (Kisunla) modestly slowed the pace of thinking declines among patients in the early.
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Binghamton researchers get FDA approval for drug to treat world’s most common genetic disease
SCIENMAG: Medicine & Health
OCTOBER 31, 2023
— A new drug developed by professors from the School of Pharmacy and Pharmaceutical Sciences at Binghamton University has received Food and Drug Administration (FDA) approval for the treatment of patients with Duchenne muscular dystrophy (DMD), a common genetic disease that mostly affects young boys.
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FDA Approves, Cobenfy, a New Kind of Drug for Schizophrenia
Drugs.com
SEPTEMBER 27, 2024
27, 2024 -- The first new type of medication in decades to help fight against schizophrenia was approved on Thursday by the U.S. Food and Drug Administration. FRIDAY, Sept. Cobenfy (xanomeline/trospium chloride) could bring patients what they've.
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Madrigal wins FDA approval of first drug for MASH
BioPharma Drive: Drug Pricing
MARCH 14, 2024
But its sales potential is unclear, and competition could emerge from popular weight loss drugs. Rezdiffra’s clearance is a turning point in the fight against the liver disease.
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FDA Approves Updated COVID Shots for Fall
Drugs.com
AUGUST 22, 2024
22, 2024 -- Updated shots to shield against COVID-19 infection were approved by the U.S. Food and Drug Administration on Thursday.This year's approval for the updated mRNA vaccines comes much sooner than happened in 2023, when fall. THURSDAY, Aug.
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FDA Approves New Drug for Deadly Lung Cancer
Drugs.com
MAY 17, 2024
Food and Drug Administration on Thursday approved a new drug to treat patients with an advanced form of deadly lung cancer. FRIDAY, MAY 17, 2024 -- The U.S. Importantly, tarlatamab (Imdelltra) is only for patients who have exhausted all other.
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The Regulatory Maze: How Generic Drugs Navigate FDA Approval
Drug Patent Watch
JULY 24, 2024
In the high-stakes world of pharmaceuticals, generic drugs have become the unsung heroes of healthcare accessibility. These cost-effective alternatives to […] Source
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FDA approves Ascendis drug for rare endocrine condition
BioPharma Drive: Drug Pricing
AUGUST 12, 2024
The clearance of Yorvipath for hypoparathyroidism was some time coming for Ascendis, which had resubmitted after receiving a rejection last year.
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FDA Approves New Drug for Deadly Lung Cancer, Imdelltra
Drugs.com
MAY 17, 2024
Food and Drug Administration on Thursday approved a new drug to treat patients with an advanced form of deadly lung cancer. FRIDAY, MAY 17, 2024 -- The U.S. Importantly, tarlatamab (Imdelltra) is only for patients who have exhausted all other.
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FDA Approves Duvystat, New Oral Treatment for Duchenne Muscular Dystrophy (DMD)
PLOS: DNA Science
MARCH 28, 2024
A new drug has entered the arsenal against Duchenne muscular dystrophy (DMD), a genetic disease that affects boys and is challenging to treat. FDA classifies it as a “nonsteroidal treatment” – not a gene therapy, but it affects gene expression. Four HDAC inhibitors have been approved so far, to treat blood cancers.
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FDA Approves First Flu Vaccine You Give Yourself at Home
Drugs.com
SEPTEMBER 20, 2024
Food and Drug Administration on Friday approved FluMist nasal spray as the first influenza vaccine that can be. FRIDAY, Sept. 20, 2024 -- The days of waiting for a flu shot at your doctor's office or local pharmacy may be over: The U.S.
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FDA Approves First Drug for Common, Serious Liver Disease
Drugs.com
MARCH 15, 2024
FRIDAY, March 15, 2024 -- Millions of Americans whose livers develop scar tissue due to a common disease now have the first approved drug, Rezdiffra, to treat the condition, the U.S. Food and Drug Administration announced Thursday.The condition is.
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FDA Approves Another Blood Test for Colon Cancer Screening
Drugs.com
JULY 29, 2024
Food and Drug Administration on Monday approved a new blood test that can spot colon cancer.In late May, an FDA advisory panel had voted 7-2 that the benefits outweigh the risks when using the Guardant Health's. MONDAY, July 29, 2024 -- The U.S.
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FDA Approves First Drug to Treat Yeast Ear Infections in Dogs
Drugs.com
MARCH 19, 2024
Food and Drug Administration has approved the first drug to treat yeast ear infections in dogs.DuOtic is also the first ear infection medication that does not contain an antibiotic, the FDA said in its approval. TUESDAY, March 19, 2024 -- The U.S.
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FDA Approves First Flu Vaccine You Give Yourself at Home, FluMist
Drugs.com
SEPTEMBER 20, 2024
Food and Drug Administration on Friday approved FluMist nasal spray as the first influenza vaccine that can be. FRIDAY, Sept. 20, 2024 -- The days of waiting for a flu shot at your doctor's office or local pharmacy may be over: The U.S.
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FDA Approves First Drug to Treat Yeast Ear Infections in Dogs, DuOtic
Drugs.com
MARCH 19, 2024
Food and Drug Administration has approved the first drug to treat yeast ear infections in dogs. DuOtic is also the first ear infection medication that does not contain an antibiotic, the FDA said in its approval. TUESDAY, March 19, 2024 -- The U.S.
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FDA Approves New COVID Booster Shots
Drugs.com
SEPTEMBER 11, 2023
Food and Drug Administration on Monday gave the green light to new COVID boosters for Americans, setting the stage for the updated vaccines to become available within days. MONDAY, Sept. 11, 2023 -- The U.S. The COVID-19 shots from Pfizer and.
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Metabolism of 2023 FDA Approved Small Molecules – PART 2
Metabolite Tales Blog
APRIL 10, 2024
Where data was publicly available, the routes of human metabolism for each of the drugs in this subset is listed in Table 1. Metabolites found in humans are also observed in monkeys, and all metabolites were found to possess <10% of the activity of the parent drug. of the administered radiolabel in the human ADME study.
FDA Approves First Self-Test Collection Kit for HPV
Drugs.com
MAY 15, 2024
Food and Drug Administration has approved a kit that will allow women to collect their own vaginal sample for HPV screening, a move that could increase early detection in those at risk for cervical cancer. WEDNESDAY, May 15, 2024 -- The U.S.
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FDA Approves New Antibiotic Against UTIs
Drugs.com
APRIL 25, 2024
Food and Drug Administration on Wednesday approved Pivya (pivmecillinam) to. THURSDAY, April 25, 2024 -- As many patients already know, urinary tract infections (UTIs) can recur despite the use of antibiotics.So, it's welcome news that the U.S.
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New JAMA Article Recommends Personal Drug Importation To Help American Patients Afford Prescription Drugs
Policy Prescription
OCTOBER 22, 2024
Harvard doctors and public health experts recommend using the website PharmacyChecker.com to find international online pharmacies to order more affordable prescription drugs for personal importation when domestic savings strategies fail. As the article notes, three in ten American adults struggle to afford prescription drugs.
Metabolism of 2022 FDA approved small molecule drugs PART 2
Metabolite Tales Blog
APRIL 4, 2023
Metabolism of 2022 FDA approved small molecule drugs part 2 Mixing it Up By Julia Shanu-Wilson In Part 1 of this topic we looked at metabolism of the small molecule drugs approved by the FDA in 2022 that were mediated by CYP3A4.
FDA Approves New Antibiotic Against UTIs, Pivya (pivmecillinam)
Drugs.com
APRIL 25, 2024
Food and Drug Administration on Wednesday approved Pivya (pivmecillinam) to. THURSDAY, April 25, 2024 -- As many patients already know, urinary tract infections (UTIs) can recur despite the use of antibiotics. So, it's welcome news that the U.S.
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FDA Approves Wegovy to Help Prevent Heart Attack, Stroke
Drugs.com
MARCH 8, 2024
FRIDAY, March 8, 2024 -- Wegovy (semaglutide), the weight-loss version of blockbuster diabetes drug Ozempic, was approved on Friday by the U.S. Food and Drug Administration to help prevent heart attack, stroke and heart death.“Wegovy Wegovy is now the.
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FDA Approves First Drug for Common, Serious Liver Disease, Rezdiffra
Drugs.com
MARCH 15, 2024
FRIDAY, March 15, 2024 -- Millions of Americans whose livers develop scar tissue due to a common disease now have the first approved drug, Rezdiffra, to treat the condition, the U.S. Food and Drug Administration announced Thursday. The condition is.
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Metabolism of 2022 FDA approved small molecule drugs PART 1
Metabolite Tales Blog
JANUARY 26, 2023
Metabolism of 2022 FDA approved small molecule drugs – Part 1 Does CYP3A4 still rule? By Julia Shanu-Wilson It won’t come as much surprise to learn that of the 17 small molecules* approved by the FDA in 2022, CYP3A4 was the major player in drug metabolism.
Madrigal, FDA approval in hand, outlines plan to sell MASH drug
BioPharma Drive: Drug Pricing
MARCH 15, 2024
The company expects initial uptake of Rezdiffra, which costs $47,400 per year, to be slow as doctors and insurers establish the protocols needed to find patients eligible for treatment.
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FDA approves Merck lung disease drug acquired in $11B deal
BioPharma Drive: Drug Pricing
MARCH 26, 2024
Merck is couting on Winrevair, which it acquired by buying Acceleron Pharma, to help soften the blow when Keytruda loses patent protection later this decade.
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Daiichi Sankyo, with new data, to seek FDA approval of lung cancer drug
BioPharma Drive: Drug Pricing
SEPTEMBER 11, 2023
The HER3-targeting treatment could become the next antibody-drug conjugate to emerge from Daiichi Sankyo’s laboratories, after the AstraZeneca-partnered Enhertu.
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FDA Approves Landmark Sickle Cell Gene Therapies
Drugs.com
DECEMBER 8, 2023
Food and Drug Administration on Friday approved two milestone gene therapies for sickle cell disease, including the first treatment ever approved that uses gene-editing technology.Casgevy, developed by Vertex. FRIDAY, Dec. 8, 2023 -- The U.S.
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FDA approves Akebia anemia pill, two years after rejection
BioPharma Drive: Drug Pricing
MARCH 28, 2024
The agency gave Akebia’s drug an OK after receiving more safety data, but imposed a strict boxed warning for its use that may limit uptake.
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Epilepsy drug prevents brain tumors in mice with NF1
Science Daily: Pharmacology News
APRIL 15, 2024
Researchers have discovered that an FDA-approved epilepsy drug can prevent or slow the growth of NF1-linked optic gliomas in mice, laying the groundwork for a clinical trial.
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FDA approves Novartis’ copycat of blockbuster Biogen drug
BioPharma Drive: Drug Pricing
AUGUST 25, 2023
According to one analyst, the approval was the last hurdle keeping Sandoz’s Tyruko from directly competing in the U.S. market against Biogen’s inflammation-regulating medicine Tysabri.
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FDA Approves AI Device That Helps Spot Skin Cancer
Drugs.com
JANUARY 18, 2024
18, 2024 (HealthDay news) -- The first medical device powered by artificial intelligence and designed to help doctors catch skin cancer has been approved by the U.S. Food and Drug Administration.Although not meant to be used as a. THURSDAY, Jan.
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FDA approves new Bristol Myers drug for lung cancer
BioPharma Drive: Drug Pricing
NOVEMBER 16, 2023
Acquired via a $4 billion biotech buyout, Augtyro is one of an array of new products the pharma hopes will offset patent expirations for current top sellers.
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FDA Approves Landmark Sickle Cell Gene Therapies, Casgevy and Lyfgenia
Drugs.com
DECEMBER 8, 2023
Food and Drug Administration on Friday approved two milestone gene therapies for sickle cell disease, including the first treatment ever approved that uses gene-editing technology. FRIDAY, Dec. 8, 2023 -- The U.S. Casgevy, developed by Vertex.
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FDA Approves First Nasal Spray to Curb Anaphylaxis, An Alternative to Injections
Drugs.com
AUGUST 9, 2024
Food and Drug Administration on Friday announced that it has approved neffy, the first. FRIDAY, Aug. 9, 2024 -- People who are nervous about administering a rescue shot for anaphylaxis finally have a new alternative in a nasal spray.The U.S.
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FDA Approves First Vaccine for Chikungunya Virus, Ixchiq
Drugs.com
NOVEMBER 10, 2023
10, 2023 (Healthday News) -- The first vaccine to prevent infection with the chikungunya virus was approved by the U.S. Food and Drug Administration on Thursday. The single-dose shot, known as Ixchiq, is approved for adults who are at. FRIDAY, Nov.
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J&J submits touted autoimmune disease drug for FDA approval
BioPharma Drive: Drug Pricing
AUGUST 29, 2024
Nipocalimab is one of several drugs J&J has forecast for multi-billion dollar sales. The company’s initial application is for its use in myasthenia gravis.
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Novartis gets FDA approval of closely watched rare disease drug
BioPharma Drive: Drug Pricing
DECEMBER 6, 2023
The pharma is developing Fabhalta, now cleared for paroxysmal nocturnal hemoglobinuria, for several other rare, complement-driven diseases.
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FDA Approves First At-Home Test for Chlamydia, Gonorrhea
Drugs.com
NOVEMBER 17, 2023
16, 2023 -- The first home test for chlamydia and gonorrhea will soon hit the market, following its approval Wednesday by the U.S. Food and Drug Administration. THURSDAY, Nov. People will be able to buy the Simple 2 Test over-the-counter at a.
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