Drugs, FDA Approval and Medicine - Clinical Research Informer

FDA approves new ALS medicine in precedent-setting decision

Bio Pharma Dive

APRIL 25, 2023

Biogen’s drug failed the key study meant to show it can slow the nerve-destroying disease, but the drug’s effect on a protein of interest led the FDA to conditionally clear it for market.

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US FDA approves Blueprint Medicines’ indolent systemic mastocytosis therapy

Pharmaceutical Technology

MAY 23, 2023

The US Food and Drug Administration (FDA) has granted approval for Blueprint Medicines’ Ayvakit (avapritinib) as the first and only treatment for indolent systemic mastocytosis (ISM) in adult patients.

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FDA approves first microbiota-based treatment

Bio Pharma Dive

DECEMBER 1, 2022

The regulatory OK, a milestone for microbiome-based drug research, is for a medicine from Ferring Pharma that treats a recurrent type of gut infection.

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AstraZeneca, Avillion get FDA approval for new ‘rescue’ drug for asthma

Bio Pharma Dive

JANUARY 11, 2023

Airsupra joins a growing portfolio of new drugs that are helping the British drugmaker offset wilting sales of older respiratory medicines like Pulmicort.

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Seagen, Genmab win speedy FDA approval for cervical cancer drug

Bio Pharma Dive

SEPTEMBER 21, 2021

Tivdak, a type of drug known as an antibody-drug conjugate, is the fourth approved medicine for Seagen and its third to reach market since December 2019.

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In historic move, FDA approves a closely watched and controversial Alzheimer's drug

Bio Pharma Dive

JUNE 7, 2021

With the decision, the agency cleared the way for what many predict will become a lucrative and highly sought-after option — though fierce debate continues over whether the medicine, Biogen's aducanumab, actually benefits patients' daily lives.

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US FDA approves Reata Pharmaceuticals’ SKYCLARYS for Friedreich’s ataxia

Pharmaceutical Technology

MARCH 2, 2023

The US Food and Drug Administration (FDA) has approved Reata Pharmaceuticals ’ oral, once-daily medication SKYCLARYS (omaveloxolone) to treat Friedreich’s ataxia patients. SKYCLARYS is the first approved treatment in Friedrich’s Ataxia and marks a milestone for drug development in this complex disease.

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Symvess: Humacyte’s FDA-Approved Bioengineered Solution for Vascular Trauma

XTalks

JANUARY 7, 2025

In a major leap forward for trauma care, Humacyte has received full approval from the US Food and Drug Administration (FDA) for Symvess, a first-of-its-kind bioengineered human tissue designed to repair extremity arterial injuries. Symvess does carry risks, including thrombosis, graft rupture and infection.

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After setback, Biohaven to seek approval of neurological disorder drug

Bio Pharma Dive

SEPTEMBER 23, 2024

With fresh, positive data in hand, Biohaven now believes its medicine could be the first to receive FDA approval for spinocerebellar ataxia.

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FDA Approves Powerful New Drug to Counter Obesity Epidemic

AuroBlog - Aurous Healthcare Clinical Trials blog

NOVEMBER 12, 2023

The US Food and Drug Administration (FDA) on Wednesday announced it had approved Eli Lilly’s highly anticipated weight loss drug Zepbound, the latest entrant in a field of powerful – and lucrative – new obesity medicines.

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Bristol Myers wins FDA approval for first drug to treat inherited heart condition

Bio Pharma Dive

APRIL 28, 2022

Bristol Myers paid $13 billion to acquire the drug's maker, MyoKardia, and expects a top-selling medicine. But a tricky dosing regimen, as well as safety concerns, could challenge the pharmaceutical giant's lofty forecast.

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Bristol Myers gets key FDA approval for bone marrow disease drug

Bio Pharma Dive

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.

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FDA approves drugs from Gilead, Roche, TG Therapeutics to close 2022

Bio Pharma Dive

JANUARY 3, 2023

The agency’s main review office cleared 37 new medicines last year, its lowest total since 2016 and well below 2021’s mark of 50.

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FDA approves Novartis’ copycat of blockbuster Biogen drug

Bio Pharma Dive

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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Novo keeps price in line with FDA approval of second obesity shot

Bio Pharma Dive

JUNE 7, 2021

Wegovy, a weekly drug, joins daily Saxenda in the pharma's portfolio, which could soon be under pressure from an experimental Lilly medicine.

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US FDA approves GSK’s Jesduvroq to treat anaemia of CKD

Pharmaceutical Technology

FEBRUARY 2, 2023

The US Food and Drug Administration (FDA) has approved GlaxoSmithKline ’s (GSK) Jesduvroq (daprodustat) to treat anaemia caused by chronic kidney disease (CKD) in adults who have been on dialysis for at least four months. Jesduvroq is an oral hypoxia-inducible factor prolyl hydroxylase inhibitor (HIF-PHI).

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Lexicon gets FDA approval for Inpefa to treat heart failure

Pharmaceutical Technology

MAY 29, 2023

Lexicon Pharmaceuticals (Lexicon) has received approval from the US Food and Drug Administration (FDA) for its Inpefa drug to treat heart failure. Inpefa is a once-daily oral tablet indicated as an inhibitor of sodium-glucose co-transporter type 2 (SGLT2) and type 1 (SGLT1).

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AstraZeneca-Daiichi Sankyo’s Enhertu gets US FDA approval for breast cancer

Pharmaceutical Technology

AUGUST 8, 2022

AstraZeneca and Daiichi Sankyo ’s Enhertu (trastuzumab deruxtecan) has received expanded approval from the US Food and Drug Administration (FDA) to treat adults with unresectable or metastatic HER2-low (IHC 1+ or IHC 2+/ISH-) breast cancer.

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Vertex gains FDA approval for expanded use of CF drug Trikafta

Pharmaceutical Technology

APRIL 27, 2023

Vertex Pharmaceuticals has received approval from the US Food and Drug Administration (FDA) to expand the use of Trikafta (elexacaftor/tezacaftor/ivacaftor and ivacaftor) to treat cystic fibrosis (CF) in children aged between two and five years with certain mutations.

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Merck, Bayer win FDA approval for heart failure drug

Bio Pharma Dive

JANUARY 20, 2021

The drugmakers could face an uphill battle, however, to market the medicine, which showed a more modest benefit than expected in a key study.

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Sage, reeling from depression drug decision, to lay off 40% of workforce

Bio Pharma Dive

AUGUST 31, 2023

Two founding executives are leaving Sage alongside a major restructuring announced weeks after the FDA approved the medicine, Zurzuvae, for much narrower use than the company had hoped.

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Akebia tries for FDA approval of anemia drug after mixed data

Bio Pharma Dive

MARCH 30, 2021

That result, and the surprisingly close FDA scrutiny of a rival medicine from FibroGen, makes the approval prospects of both treatments uncertain. The drugmaker's pill fell short on a critical safety measure in two large trials last fall.

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Catalent Signs Commercial Supply Agreement with Blueprint Medicines Following FDA Approval of GAVRETO™ (pralsetinib)

Pharma Mirror

NOVEMBER 24, 2020

Catalent, the leading global provider of advanced delivery technologies, development, and manufacturing solutions for drugs, biologics, cell and gene therapies, and consumer health products, today announced that it had entered into a commercial supply agreement with Blueprint Medicines following FDA approval of GAVRETO™ (pralsetinib).

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FDA approves drugs from Vertex, Novo, Bristol Myers to wrap 2024

Bio Pharma Dive

JANUARY 2, 2025

The agency’s main drug review office cleared 50 novel medicines last year, short of 2018’s record total but on the higher end of recent annual tallies.

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FDA approves GSK’s new bone cancer drug, helping validate a billion-dollar bet

Bio Pharma Dive

SEPTEMBER 18, 2023

The drug, known scientifically as momelotinib, is now cleared to treat myelofibrosis and will compete against rival medicines sold by Incyte and Bristol Myers Squibb.

FDA Approval

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AGEPHA Pharma’s LODOCO gets US FDA approval for cardiovascular disease

Pharmaceutical Technology

JUNE 21, 2023

AGEPHA Pharma has received approval from the US Food and Drug Administration (FDA) for LODOCO (colchicine, 0.5 It can be used as a monotherapy or along with cholesterol-lowering medicines. It is claimed to be the first anti-inflammatory atheroprotective cardiovascular treatment to receive approval from the regulator.

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Alnylam wins FDA approval of rare disease drug in step toward profitability

Bio Pharma Dive

JUNE 14, 2022

Amvuttra, a transthyretin amyloidosis medicine previously known as vutrisiran, is viewed by biotech analysts as important to the company’s goal of ending years of financial losses.

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Ctexli (Chenodiol) Gains FDA Approval as First CTX Treatment

XTalks

FEBRUARY 25, 2025

Mirum Pharmaceuticals, a biotech innovator known for developing therapies for rare metabolic disorders, now has FDA approval for its new treatment, Ctexli (chenodiol) tablets the first and only medication approved for cerebrotendinous xanthomatosis (CTX) in adults.

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Coherus wins FDA approval for second Lucentis biosimilar, its third drug

Bio Pharma Dive

AUGUST 3, 2022

The biotech company secured a valuable interchangeable designation for the copycat medicine, which it plans to launch later this year.

FDA Approval

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AstraZeneca and MSD’s Lynparza combo bags FDA approval for prostate cancer

Pharmaceutical Technology

JUNE 1, 2023

The US Food and Drug Administration (FDA) has granted a combination of AstraZeneca and MSD ’s Lynparza (olaparib), with standard therapies for treating BRCA-mutated (BRCAm) metastatic castration-resistant prostate cancer (mCRPC). A prior orchiectomy or receipt of gonadotropin-releasing hormone (GnRH) analogs was also necessary.

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US FDA approves Amgen-AstraZeneca’s Tezspire for asthma treatment

Pharmaceutical Technology

FEBRUARY 3, 2023

The US Food and Drug Administration (FDA) has granted approval to Amgen and AstraZeneca ’s Tezspire (tezepelumab-ekko) for self-administration using a single-use, pre-filled pen for severe asthma patients aged 12 years and above. Pharyngitis, arthralgia, and back pain are the most common adverse reactions of the antibody.

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Pfizer’s sNDA for Cibinqo receives FDA approval for atopic dermatitis

Pharmaceutical Technology

FEBRUARY 13, 2023

Pfizer has received the US Food and Drug Administration (FDA) approval for its supplemental New Drug Application (sNDA) for Cibinqo (abrocitinib) to treat a type of atopic dermatitis (AD). The post Pfizer’s sNDA for Cibinqo receives FDA approval for atopic dermatitis appeared first on Pharmaceutical Technology.

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Drug companies know how to play the FDA drug approval process

World of DTC Marketing

JULY 13, 2021

SUMMARY: The FDA has many puzzled as to why they approve some drugs with questionable data and ask for more data on other drugs. The FDA approves drugs on the potential to save a life, the cost of the drugs is never considered in the process. Drug companies know how to play the system.

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Rare Disease Spotlight – tracing the rise of orphan drug designations over almost 40 years

Pharmaceutical Technology

JUNE 29, 2022

The US Food and Drug Administration (FDA) put a high-profile bluebird bio trial for sickle cell disease on partial clinical hold, and advisory panels deliberated over decisions involving gene therapies for amyotrophic lateral sclerosis (ALS), cerebral adrenoleukodystrophy (CALD), and beta-thalassemia.

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FDA approves Reata rare disease drug in controversial decision

Bio Pharma Dive

MARCH 1, 2023

The clearance, the first for a medicine meant to treat Friedreich’s ataxia, comes after years of questions about its purported benefits and sent the drugmaker’s shares soaring.

FDA Approval

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Teva, MedinCell receive FDA approval for Uzedy to treat schizophrenia

Pharmaceutical Technology

MAY 1, 2023

Teva Pharmaceuticals and MedinCell have received approval from the US Food and Drug Administration (FDA) for Uzedy (risperidone) extended-release injectable suspension to treat adult patients with schizophrenia, a chronic, progressive, and severely debilitating mental health disorder.

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US FDA approves Pharming’s Joenja to treat APDS

Pharmaceutical Technology

MARCH 27, 2023

The US Food and Drug Administration (FDA) has granted approval for Pharming Group’s Joenja (leniolisib) to treat adult and paediatric patients aged 12 years and above with activated phosphoinositide 3-kinase delta (PI3Kδ) syndrome (APDS). Joenja is an oral, selective small molecule PI3Kẟ inhibitor.

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US FDA approves Vertex’s Orkambi for cystic fibrosis in children

Pharmaceutical Technology

SEPTEMBER 5, 2022

The US Food and Drug Administration (FDA) has approved the expanded usage of Vertex Pharmaceuticals ’ Orkambi (lumacaftor/ivacaftor) to treat cystic fibrosis (CF) in children aged 12 months to under 24 months. It enrolled 46 children aged one to under two years with the F/F genotype.

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Lilly’s new drug Mounjaro (tirzepatide ) wins US FDA approval

pharmaphorum

MAY 16, 2022

Blood sugar control drug Mounjaro has been granted US regulatory approval, giving type 2 diabetics another way to help keep their glucose levels in check. The drug is injected under the skin once a week and the dose can be adjusted to meet an individual’s blood sugar needs.

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FDA approves Ipsen’s Bylvay for cholestatic pruritus due to ALGS

Pharmaceutical Technology

JUNE 14, 2023

Ipsen has received US Food and Drug Administration (FDA) approval for Bylvay (odevixibat) to treat patients aged 12 months and above with cholestatic pruritus caused by Alagille syndrome (ALGS). More than 90% of patients who received treatment with odevixibat were pruritus responders.

FDA Approval

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Blueprint Medicines announces financing partnerships for $1.25bn

Pharmaceutical Technology

JULY 1, 2022

Blueprint Medicines has entered strategic financing partnerships for up to $1.25bn with life sciences-focused investors Sixth Street and Royalty Pharma. Ayvakit has received the US Food and Drug Administration (FDA) approval to treat advanced systemic mastocytosis in adults.

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Acute Leukemia Drug Revuforj Wins FDA Approval, Second Approval for Syndax this Year

XTalks

NOVEMBER 27, 2024

Syndax Pharmaceuticals’ Revuforj (revumenib) has won US Food and Drug Administration (FDA) approval for the treatment of relapsed or refractory (R/R) acute leukemia in patients aged one year and older who have a lysine methyltransferase 2A ( KMT2A, formerly MLL ) gene translocation.

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Blue Water Biotech shores up portfolio with purchase of six FDA-approved treatments

Pharmaceutical Technology

JUNE 14, 2023

All six treatments are US Food and Drug Administration (FDA) approved. The six newly acquired medicines join Entadfi (finasteride and tadalafil) in Blue Water’s portfolio. Blue Water bought the FDA-approved benign prostatic hyperplasia treatment from Veru for a total cost of $100m in April 2023. “We

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Argenx wins FDA approval for under-the-skin injection of rare disease drug

Bio Pharma Dive

JUNE 21, 2023

Clearance of a subcutaneous form of Argenx’s medicine, known as Vyvgart, could help pad a launch that’s already exceeded Wall Street expectations.

FDA Approval

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FDA approves new ALS medicine in precedent-setting decision

US FDA approves Blueprint Medicines’ indolent systemic mastocytosis therapy

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FDA approves first microbiota-based treatment

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AstraZeneca, Avillion get FDA approval for new ‘rescue’ drug for asthma

Seagen, Genmab win speedy FDA approval for cervical cancer drug

In historic move, FDA approves a closely watched and controversial Alzheimer's drug

US FDA approves Reata Pharmaceuticals’ SKYCLARYS for Friedreich’s ataxia

Symvess: Humacyte’s FDA-Approved Bioengineered Solution for Vascular Trauma

After setback, Biohaven to seek approval of neurological disorder drug

FDA Approves Powerful New Drug to Counter Obesity Epidemic

Bristol Myers wins FDA approval for first drug to treat inherited heart condition

Bristol Myers gets key FDA approval for bone marrow disease drug

FDA approves drugs from Gilead, Roche, TG Therapeutics to close 2022

FDA approves Novartis’ copycat of blockbuster Biogen drug

Novo keeps price in line with FDA approval of second obesity shot

US FDA approves GSK’s Jesduvroq to treat anaemia of CKD

Lexicon gets FDA approval for Inpefa to treat heart failure

AstraZeneca-Daiichi Sankyo’s Enhertu gets US FDA approval for breast cancer

Vertex gains FDA approval for expanded use of CF drug Trikafta

Merck, Bayer win FDA approval for heart failure drug

Sage, reeling from depression drug decision, to lay off 40% of workforce

Akebia tries for FDA approval of anemia drug after mixed data

Catalent Signs Commercial Supply Agreement with Blueprint Medicines Following FDA Approval of GAVRETO™ (pralsetinib)

FDA approves drugs from Vertex, Novo, Bristol Myers to wrap 2024

FDA approves GSK’s new bone cancer drug, helping validate a billion-dollar bet

AGEPHA Pharma’s LODOCO gets US FDA approval for cardiovascular disease

Alnylam wins FDA approval of rare disease drug in step toward profitability

Ctexli (Chenodiol) Gains FDA Approval as First CTX Treatment

Coherus wins FDA approval for second Lucentis biosimilar, its third drug

AstraZeneca and MSD’s Lynparza combo bags FDA approval for prostate cancer

US FDA approves Amgen-AstraZeneca’s Tezspire for asthma treatment

Pfizer’s sNDA for Cibinqo receives FDA approval for atopic dermatitis

Drug companies know how to play the FDA drug approval process

Rare Disease Spotlight – tracing the rise of orphan drug designations over almost 40 years

FDA approves Reata rare disease drug in controversial decision

Teva, MedinCell receive FDA approval for Uzedy to treat schizophrenia

US FDA approves Pharming’s Joenja to treat APDS

US FDA approves Vertex’s Orkambi for cystic fibrosis in children

Lilly’s new drug Mounjaro (tirzepatide ) wins US FDA approval

FDA approves Ipsen’s Bylvay for cholestatic pruritus due to ALGS

Blueprint Medicines announces financing partnerships for $1.25bn

Acute Leukemia Drug Revuforj Wins FDA Approval, Second Approval for Syndax this Year

Blue Water Biotech shores up portfolio with purchase of six FDA-approved treatments

Argenx wins FDA approval for under-the-skin injection of rare disease drug

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