Drugs and FDA Approval - Clinical Research Informer

Madrigal wins FDA approval of first drug for MASH

Bio Pharma Dive

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 Ascendis Pharma’s YORVIPATH for hypoparathyroidism

Pharmaceutical Technology

AUGUST 13, 2024

Ascendis Pharma has obtained US Food and Drug Administration (FDA) approval for its YORVIPATH to treat hypoparathyroidism in adults.

FDA Approval

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US FDA approves Bausch + Lomb and Novaliq’s DED treatment Miebo

Pharmaceutical Technology

MAY 19, 2023

The US Food and Drug Administration (FDA) has granted approval to Bausch + Lomb and Novaliq’s Miebo (perfluorohexyloctane ophthalmic solution) to treat the signs and symptoms of dry eye disease (DED). It is the first and only prescription eye drop to receive FDA approval to treat DED that targets tear evaporation directly.

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In first, FDA approves KRAS-blocking cancer drug from Amgen

Bio Pharma Dive

MAY 28, 2021

Lumakras is the first drug proven effective. For decades, scientists have tried unsuccessfully to target the KRAS gene, which is often mutated in lung, colon and pancreatic cancers.

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FDA approves first-of-its-kind lupus drug

Bio Pharma Dive

JANUARY 25, 2021

Lupkynis, the first oral drug approved for lupus nephritis, comes with a high list price. Its developer, Aurinia Pharmaceuticals, expects average net revenue of roughly $65,000 per patient per year.

FDA Approval

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Lilly wins FDA approval of new kind of diabetes drug

Bio Pharma Dive

MAY 13, 2022

Tirzepatide, now branded as Mounjaro, helped improve blood sugar control in testing and has been shown to have powerful weight loss effects as well, making it one of the most closely watched drugs in Lilly's pipeline.

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FDA Approves New Alzheimer’s Drug Designed to Slow Cognitive Decline

AuroBlog - Aurous Healthcare Clinical Trials blog

JANUARY 10, 2023

The US Food and Drug Administration (FDA) on Friday approved a highly anticipated new drug designed to slow cognitive decline in patients in mild and early stages of Alzheimer’s disease.

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FDA approves Alzheimer’s drug from Eisai, Biogen in closely watched decision

Bio Pharma Dive

JANUARY 6, 2023

The agency’s approval comes months after a large clinical trial showed the drug, called Leqembi, could slow the disease’s progression. Yet experts have raised concerns about its safety.

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US FDA approves Shorla’s oncology drug for T-cell leukaemia

Pharmaceutical Technology

MARCH 8, 2023

The US Food and Drug Administration (FDA) has granted approval for Shorla Oncology’s Nelarabine Injection, an oncology drug, to treat T-cell leukaemia, an aggressive blood and bone marrow cancer that progresses quickly. The company develops innovative oncology drugs with a focus on paediatric and orphan cancers.

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Gilead's Veklury becomes first FDA-approved drug for COVID-19

Bio Pharma Dive

OCTOBER 22, 2020

regulator granted a full approval after allowing emergency use earlier this year. New results from an WHO study, however, raise questions about the drug's ultimate effectiveness.

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Xolair amplifies reach after FDA approval for treating food allergies

Pharmaceutical Technology

FEBRUARY 20, 2024

Xolair is the first FDA-approved drug to reduce allergic reactions in people with one or more food allergies, as per Roche’s announcement.

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Seagen, Astellas win expanded FDA approval for bladder cancer drug

Bio Pharma Dive

APRIL 4, 2023

The first-line approval of Padcev together with Keytruda is viewed as important to expanding the drug’s market, and comes weeks after Pfizer agreed to buy Seagen for $43 billion.

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AstraZeneca wins first FDA approval for systemic lupus drug in a decade

Bio Pharma Dive

AUGUST 2, 2021

The regulator cleared Saphnelo despite mixed clinical trial data, giving patients another option after the recent OK for a drug aimed at the autoimmune disease's severe side effects.

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FDA approves Seres’ microbiota drug for recurrent gut infection

Bio Pharma Dive

APRIL 26, 2023

The drug is the first microbiota-based pill to win U.S. Like a rival therapy approved in December, it’s for difficult-to-treat C. diff infections.

FDA Approval

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FDA approves cancer drugs from Lilly, Menarini

Bio Pharma Dive

JANUARY 30, 2023

The agency’s clearance of Jaypirca gives Lilly another win from its Loxo buyout, while Menarini Group’s bet on Radius Health’s oral SERD has now paid off with Orserdu’s OK.

FDA Approval

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FDA approves Sanofi’s long-lasting hemophilia drug

Bio Pharma Dive

FEBRUARY 23, 2023

Sanofi and its development partner, Sobi, claim the drug’s once-a-week dosing, and its effect on blood-clotting protein levels, will help it compete in the crowded market for hemophilia A treatments.

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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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First-of-its-kind Type 1 diabetes drug wins FDA approval

Bio Pharma Dive

NOVEMBER 18, 2022

To be sold as Tzield, the drug will cost $193,900 for a typical full regimen. Provention Bio’s teplizumab is meant to prevent the onset of Type 1 diabetes.

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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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Novartis wins FDA approval for new heart drug, but faces uphill sales battle

Bio Pharma Dive

DECEMBER 22, 2021

But uptake could be slow as insurers and doctors weigh the drug's safety and cost-effectiveness. Leqvio, which Novartis acquired for nearly $10 billion two years ago, arrives with high sales expectations.

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Specialised Therapeutics’ breast cancer drug gets Philippines FDA approval

Pharmaceutical Technology

JULY 8, 2022

Specialised Therapeutics’ oral drug, Nerlynx (neratinib) has obtained the Philippines Food and Drug Administration approval to lower the recurrence or mortality risk in early-stage HER2-positive (HER2+) breast cancer patients.

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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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FDA approves Regeneron drug for rare, genetic form of high cholesterol

Bio Pharma Dive

FEBRUARY 12, 2021

The biotech set an average annual price of $450,000 for the first-of-its-kind drug, which treats a condition that affects about 1,300 people in the U.S.

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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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FDA approves oral version of Mitsubishi's ALS drug

Bio Pharma Dive

MAY 13, 2022

Called Radicava ORS, this version is taken by mouth rather than via an hourlong infusion, which may help improve the drug's convenience and use.

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Takeda wins FDA approval for targeted lung cancer drug

Bio Pharma Dive

SEPTEMBER 16, 2021

Unlike J&J's drug, however, Takeda's is given orally. Exkivity follows Johnson & Johnson's Rybrevant on the market for treating lung tumors harboring specific mutations in the EGFR gene.

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Roche wins FDA approval for rival to Regeneron's lucrative eye drug

Bio Pharma Dive

JANUARY 31, 2022

The drug, which will be sold as Vabysmo, is the first of several emerging competitive threats to Regeneron's top-selling Eylea, along with biosimilars and long-acting implants.

FDA Approval

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

Bio Pharma Dive

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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GPCR-targeting drugs: A renewed focus on a ubiquitous group of proteins

Bio Pharma Dive

MARCH 7, 2023

As many as a third of FDA-approved drugs target GPCRs in some fashion, with uses ranging from treating cancer to pain. But biotech startups say there is still room to develop more.

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FDA approves Ascendis drug for rare endocrine condition

Bio Pharma Dive

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

Bio Pharma Dive

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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US FDA approves Ferring’s Rebyota for Clostridioides difficile infection

Pharmaceutical Technology

DECEMBER 1, 2022

The US Food and Drug Administration (FDA) has granted approval for Ferring Pharmaceuticals’ faecal microbiota product, Rebyota, to prevent Clostridioides difficile infection (CDI) recurrence in people aged 18 years and above. A live biotherapeutic, Rebyota is intended for usage following the completion of antibiotic treatment.

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5 FDA approval decisions to watch in the second quarter

Bio Pharma Dive

MARCH 29, 2021

A long-awaited reckoning for Biogen’s Alzheimer’s drug and the review of AstraZeneca’s coronavirus vaccine are among the top FDA decisions expected before the end of June.

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FDA approves AbbVie, Pfizer drugs for eczema, creating competition for Sanofi

Bio Pharma Dive

JANUARY 18, 2022

AbbVie's Rinvoq and Pfizer's Cibinqo are both JAK-inhibiting drugs that are taken orally, a convenience which could help them compete against injectable treatments like Sanofi and Regeneron's Dupixent.

FDA Approval

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

Bio Pharma Dive

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.

FDA Approval

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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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5 FDA approval decisions to watch in the 1st quarter

Bio Pharma Dive

JANUARY 5, 2021

By March, the FDA expects to conclude reviews of key drugs for heart failure, Duchenne's and multiple myeloma, as well as decide on whether to clear Biogen's controversial Alzheimer's treatment.

FDA Approval

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US FDA approves Daiichi Sankyo-AstraZeneca’s Enhertu for lung cancer

Pharmaceutical Technology

AUGUST 12, 2022

The US Food and Drug Administration (FDA) has granted approval for Daiichi Sankyo and AstraZeneca ’s Enhertu (fam-trastuzumab deruxtecan-nxki) to treat unresectable or metastatic non-small cell lung cancer (NSCLC) in adults. In the trial, 1.9%

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Sarepta wins FDA approval of another drug for rare muscular dystrophy

Bio Pharma Dive

FEBRUARY 25, 2021

Like other Sarepta drugs, it comes with a high price tag and its clinical benefits haven't been confirmed. Amondys 45 is now cleared for the estimated 8% of Duchenne patients eligible for treatment.

FDA Approval

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Lilly drug Mounjaro succeeds in second weight loss study

Bio Pharma Dive

APRIL 27, 2023

Trial participants lost up to 15% of their body weight in a finding that should help the closely watched GLP-1 drug gain an FDA approval for obesity.

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Biohaven to seek FDA approval for second migraine drug after study success

Bio Pharma Dive

DECEMBER 6, 2021

The biotech's drug, called zavegepant, is delivered intranasally and could offer a similar convenience advantage as its first, the fast-selling Nurtec ODT.

FDA Approval

FDA Approval Drugs

Apellis wins FDA approval of first drug for type of vision loss

Bio Pharma Dive

FEBRUARY 17, 2023

Apellis’ Syfovre is the first marketed treatment for geographic atrophy, a common and irreversible eye condition. But questions linger about its benefit and safety.

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5 FDA approval decisions to watch in the 4th quarter

Bio Pharma Dive

SEPTEMBER 29, 2020

The world's attention will be on the FDA as it considers initial data from coronavirus vaccine developers. But several other important drugs, including a CAR-T therapy and an Ebola antibody, will also be on the agency's agenda.

FDA Approval

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Madrigal wins FDA approval of first drug for MASH

FDA approves Ascendis Pharma’s YORVIPATH for hypoparathyroidism

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US FDA approves Bausch + Lomb and Novaliq’s DED treatment Miebo

In first, FDA approves KRAS-blocking cancer drug from Amgen

FDA approves first-of-its-kind lupus drug

Lilly wins FDA approval of new kind of diabetes drug

FDA Approves New Alzheimer’s Drug Designed to Slow Cognitive Decline

FDA approves Alzheimer’s drug from Eisai, Biogen in closely watched decision

US FDA approves Shorla’s oncology drug for T-cell leukaemia

Gilead's Veklury becomes first FDA-approved drug for COVID-19

Xolair amplifies reach after FDA approval for treating food allergies

Seagen, Astellas win expanded FDA approval for bladder cancer drug

AstraZeneca wins first FDA approval for systemic lupus drug in a decade

FDA approves Seres’ microbiota drug for recurrent gut infection

FDA approves cancer drugs from Lilly, Menarini

FDA approves Sanofi’s long-lasting hemophilia drug

FDA approves first microbiota-based treatment

First-of-its-kind Type 1 diabetes drug wins FDA approval

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

Novartis wins FDA approval for new heart drug, but faces uphill sales battle

Specialised Therapeutics’ breast cancer drug gets Philippines FDA approval

Seagen, Genmab win speedy FDA approval for cervical cancer drug

FDA approves Regeneron drug for rare, genetic form of high cholesterol

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

FDA approves oral version of Mitsubishi's ALS drug

Takeda wins FDA approval for targeted lung cancer drug

Roche wins FDA approval for rival to Regeneron's lucrative eye drug

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

GPCR-targeting drugs: A renewed focus on a ubiquitous group of proteins

FDA approves Ascendis drug for rare endocrine condition

FDA approves new ALS medicine in precedent-setting decision

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

US FDA approves Ferring’s Rebyota for Clostridioides difficile infection

5 FDA approval decisions to watch in the second quarter

FDA approves AbbVie, Pfizer drugs for eczema, creating competition for Sanofi

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

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

5 FDA approval decisions to watch in the 1st quarter

US FDA approves Daiichi Sankyo-AstraZeneca’s Enhertu for lung cancer

Sarepta wins FDA approval of another drug for rare muscular dystrophy

Lilly drug Mounjaro succeeds in second weight loss study

Biohaven to seek FDA approval for second migraine drug after study success

Apellis wins FDA approval of first drug for type of vision loss

5 FDA approval decisions to watch in the 4th quarter

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