FDA Approval - Drug Discovery Digest

Madrigal wins FDA approval of first drug for MASH

BioPharma Drive: Drug Pricing

MARCH 14, 2024

Rezdiffra’s clearance is a turning point in the fight against the liver disease. But its sales potential is unclear, and competition could emerge from popular weight loss drugs.

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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. This marks the second-highest count in the past 30 years, with the highest being 59 new drug approvals in 2018 and represents an impressive 50% increase in drugs approved in 2022.

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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 COVID Booster Shots

Drugs.com

SEPTEMBER 11, 2023

MONDAY, Sept. 11, 2023 -- The U.S. 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. The COVID-19 shots from Pfizer and.

FDA Approval

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BioMarin finally secures FDA approval of hemophilia gene therapy

BioPharma Drive: Drug Pricing

JUNE 29, 2023

After a prolonged journey, the medicine, known as Roctavian, is now cleared for certain patients with hemophilia A, the more common form of the rare bleeding disorder.

FDA Approval

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FDA approves updated COVID boosters from Pfizer, Moderna

BioPharma Drive: Drug Pricing

SEPTEMBER 11, 2023

Pfizer and Moderna, which have seen slowing demand for their coronavirus vaccines, expect to make the reformulated shots available in the U.S. in the coming days.

FDA Approval

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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.

FDA Approval

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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.

FDA Approval

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Pfizer wins FDA approval of new meningococcal vaccine

BioPharma Drive: Drug Pricing

OCTOBER 23, 2023

The clearance of the pentavalent shot Penbraya adds to Pfizer’s infectious disease portfolio as it adjusts to slumping COVID-19 vaccine sales.

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FDA Approves Duvystat, New Oral Treatment for Duchenne Muscular Dystrophy (DMD)

PLOS: DNA Science

MARCH 28, 2024

Results from the study that led to the FDA approval appeared in The Lancet Neurology in April 2024 with commentary. The post FDA Approves Duvystat, New Oral Treatment for Duchenne Muscular Dystrophy (DMD) appeared first on DNA Science.

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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 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 new CAR-T competitor to Gilead’s Tecartus

BioPharma Drive: Drug Pricing

NOVEMBER 11, 2024

Developer Autolus set a list price of $525,000 for its new cell therapy, which it will sell for a type of leukemia under the brand name Aucatzyl.

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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.

FDA Approval

FDA Approval FDA Drugs

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 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 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.

FDA Approval

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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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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. BINGHAMTON, N.Y.

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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 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. THURSDAY, Jan. Food and Drug Administration.Although not meant to be used as a.

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FDA Approves First Blood Test to Predict Preeclampsia in Pregnant Women

Drugs.com

JULY 5, 2023

WEDNESDAY, July 5, 2023 -- A new blood test approved by the U.S. Food and Drug Administration can predict imminent preeclampsia, helping pregnant women who are at risk for this severe and sometimes deadly form of high blood pressure. The test can.

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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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Pfizer wins FDA approval for its $7B colitis drug

BioPharma Drive: Drug Pricing

OCTOBER 13, 2023

Acquired with the buyout of Arena Pharmaceuticals, Velsipity enters a competitive market for ulcerative colitis pills.

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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 Linzess to Treat Constipation in Children, Teens

Drugs.com

JUNE 14, 2023

Food and Drug Administration approved Linzess (linaclotide) as a once-daily treatment for pediatric patients ages 6 to 17 years with functional constipation. The approval was based on data from 328 participants. WEDNESDAY, June 14, 2023 -- The U.S.

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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.

FDA Approval

FDA Approval FDA Drugs

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. FRIDAY, Sept. Food and Drug Administration.Cobenfy (xanomeline/trospium chloride) could bring patients what they've.

FDA Approval

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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 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.

FDA Approval

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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. FRIDAY, Sept. Food and Drug Administration. Cobenfy (xanomeline/trospium chloride) could bring patients what they've.

FDA Approval

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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

FDA Approval

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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. THURSDAY, Nov. Food and Drug Administration. People will be able to buy the Simple 2 Test over-the-counter at a.

FDA Approval

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FDA Approves First Generics for Vyvanse

Drugs.com

AUGUST 30, 2023

August 28, 2023 -- FDA has approved several first generics of Vyvanse (lisdexamfetamine dimesylate) capsules and chewable tablets for attention-deficit/hyperactivity disorder (ADHD) in patients six years and older and moderate to severe binge-eating.

FDA Approval

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FDA Approval of New COVID Boosters Could Come by Friday

Drugs.com

SEPTEMBER 7, 2023

Food and Drug Administration plans say boosters could be approved as soon as Friday, NBC News. THURSDAY, Sept. 7, 2023 -- New COVID-19 booster shots could soon pass the needed hurdles for vaccinations to begin next week. Sources familiar with U.S.

FDA Approval

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Behind the new kind of cell therapy that just won FDA approval

BioPharma Drive: Drug Pricing

FEBRUARY 21, 2024

One expert views Amtagvi’s approval as a catalyst for further investment in TIL therapies, akin to how Kymriah’s 2017 clearance buoyed CAR-T treatment.

FDA Approval

FDA Approval Therapies FDA Treatment

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. The single-dose shot, known as Ixchiq, is approved for adults who are at. FRIDAY, Nov. Food and Drug Administration on Thursday.

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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.

FDA Approval

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Bristol Myers gets key FDA approval for bone marrow disease drug

BioPharma Drive: Drug Pricing

AUGUST 29, 2023

A broadened clearance for Reblozyl in myelodysplastic syndromes should help Bristol Myers offset the looming loss of revenue from top-selling medicines set to soon lose market exclusivity.

FDA Approval

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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.

FDA Approval

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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.

FDA Approval

FDA Approval FDA Drugs

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.

FDA Approval

FDA Approval FDA Drugs

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.

FDA Approval

FDA Approval Therapies FDA Treatment

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.

FDA Approval

FDA Approval FDA Drugs

Madrigal wins FDA approval of first drug for MASH

FDA Approved Oncology Drugs 2023

Trending Sources

FDA Approves Updated COVID Shots for Fall

FDA Approves New COVID Booster Shots

BioMarin finally secures FDA approval of hemophilia gene therapy

FDA approves updated COVID boosters from Pfizer, Moderna

FDA approves Ascendis drug for rare endocrine condition

FDA Approves New Drug to Treat Alzheimer's, Kisunla

Pfizer wins FDA approval of new meningococcal vaccine

FDA Approves Duvystat, New Oral Treatment for Duchenne Muscular Dystrophy (DMD)

Madrigal, FDA approval in hand, outlines plan to sell MASH drug

FDA Approves Another Blood Test for Colon Cancer Screening

FDA approves new CAR-T competitor to Gilead’s Tecartus

FDA approves Akebia anemia pill, two years after rejection

FDA Approves First Self-Test Collection Kit for HPV

FDA Approves Wegovy to Help Prevent Heart Attack, Stroke

FDA Approves New Drug to Treat Alzheimer's

FDA approves Merck lung disease drug acquired in $11B deal

Binghamton researchers get FDA approval for drug to treat world’s most common genetic disease

FDA Approves First Flu Vaccine You Give Yourself at Home

FDA Approves AI Device That Helps Spot Skin Cancer

FDA Approves First Blood Test to Predict Preeclampsia in Pregnant Women

FDA Approves Landmark Sickle Cell Gene Therapies, Casgevy and Lyfgenia

Pfizer wins FDA approval for its $7B colitis drug

Novartis gets FDA approval of closely watched rare disease drug

FDA Approves Linzess to Treat Constipation in Children, Teens

FDA Approves New Antibiotic Against UTIs, Pivya (pivmecillinam)

FDA Approves New Kind of Drug for Schizophrenia

FDA Approves First Flu Vaccine You Give Yourself at Home, FluMist

FDA approves new Bristol Myers drug for lung cancer

FDA Approves, Cobenfy, a New Kind of Drug for Schizophrenia

The Regulatory Maze: How Generic Drugs Navigate FDA Approval

FDA Approves First At-Home Test for Chlamydia, Gonorrhea

FDA Approves First Generics for Vyvanse

FDA Approval of New COVID Boosters Could Come by Friday

Behind the new kind of cell therapy that just won FDA approval

FDA Approves First Vaccine for Chikungunya Virus, Ixchiq

FDA Approves New Drug for Deadly Lung Cancer

Bristol Myers gets key FDA approval for bone marrow disease drug

Daiichi Sankyo, with new data, to seek FDA approval of lung cancer drug

FDA Approves First Drug to Treat Yeast Ear Infections in Dogs, DuOtic

FDA Approves New Antibiotic Against UTIs

FDA Approves Landmark Sickle Cell Gene Therapies

FDA Approves First Drug to Treat Yeast Ear Infections in Dogs

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