Bio Pharma Dive

AUGUST 19, 2022

A year after finding flaws in the biotech’s application, the regulator cleared a treatment some analysts view as a blockbuster-to-be, sending shares up by as much as 40%.

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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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Pharmaceutical Technology

MARCH 23, 2023

The US Food and Drug Administration (FDA) has approved Incyte ’s Zynyz (retifanlimab-dlwr) to treat metastatic or recurrent locally advanced merkel cell carcinoma (MCC) in adult patients. Zynyz (retifanlimab-dlwr) is a humanised monoclonal antibody targeting programmed death receptor-1 (PD-1).

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Pharmaceutical Technology

JUNE 21, 2023

It is claimed to be the first anti-inflammatory atheroprotective cardiovascular treatment to receive approval from the regulator. The regulatory approval was based on the findings obtained from a double-blind, multinational, placebo-controlled, randomised clinical trial conducted in 5,522 chronic coronary disease patients.

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Pharmaceutical Technology

MAY 11, 2023

Otsuka Pharmaceutical and H Lundbeck have received approval for the supplemental new drug application (sNDA) from the US Food and Drug Administration for Rexulti (brexpiprazole) to treat agitation associated with dementia due to Alzheimer’s disease. The regulator accepted and gr anted priority review for the sNDA in January 2023.

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Pharmaceutical Technology

SEPTEMBER 5, 2022

The treatment is indicated for CF patients who are homozygous for the F508del mutation (F/F genotype) in the cystic fibrosis transmembrane conductance regulator (CFTR) gene. Earlier, the therapy had obtained FDA approval for usage in CF patients aged two years and above with two F508del mutation copies.

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XTalks

JANUARY 6, 2025

The US Food and Drug Administration (FDA) has approved Alyftrek (vanzacaftor/tezacaftor/deutivacaftor), a next-in-class triple combination cystic fibrosis transmembrane conductance regulator (CFTR) modulator, to treat cystic fibrosis (CF) in patients aged six years and older with at least one F508del mutation or another responsive CFTR mutation.

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XTalks

JANUARY 21, 2025

TriClip G4 System Manufacturer/developer : Abbott Medical Date of FDA approval : April 1, 2024 Approved for : Tricuspid regurgitation (TR). The tricuspid valve, one of the heart’s four valves, regulates blood flow from the right atrium to the right ventricle, preventing backflow between these chambers.

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Pharmaceutical Technology

MAY 22, 2023

Epkinly has been approved as the first and only T-cell-engaging bispecific antibody to treat adults with DLBCL not otherwise specified (NOS), including DLBCL arising from indolent lymphoma and high-grade B–cell lymphoma (HGBL), following two or more lines of systemic therapies.

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BioPharma Reporter

NOVEMBER 19, 2024

PTC Therapeutics has received FDA approval for a gene therapy to treat AADC deficiency, a rare genetic disorder that impairs the normal function of neurons.

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BioPharma Reporter

JULY 29, 2021

Yesterday saw the US Food and Drug Administration (FDA) approve the first interchangeable biosimilar drug.

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Pharmaceutical Technology

MAY 22, 2023

It is claimed to be both the first re-dosable gene therapy and the first and only FDA-approved treatment for both recessive and dominant types of DEB, a rare and serious genetic disease affecting the skin and mucosal tissues.

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BioPharma Reporter

NOVEMBER 19, 2024

PTC Therapeutics has received FDA approval for a gene therapy to treat AADC deficiency, a rare genetic disorder that impairs the normal function of neurons.

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Fierce Pharma

APRIL 26, 2024

Ten years after dipping its toes into the gene therapy pool in a licensing deal with Spark Therapeutics, Pfizer has gained FDA approval for the acquired treatment. | Ten years after dipping its toe into the gene therapy pool in a licensing deal with Spark Therapeutics, Pfizer has gained an FDA approval for the acquired treatment.

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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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Pharmaceutical Technology

APRIL 11, 2023

It carries out operations in the regulated markets of the US and Europe, as well as in Latin America and South Africa. Zydus has manufacturing sites and research facilities across five Indian states, including Gujarat, Maharashtra, Goa, Himachal Pradesh and Sikkim.

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XTalks

APRIL 3, 2024

Related: Novartis’ Fabhalta Gets FDA Approval for Rare Complement Blood Disorder The FDA’s green light for Voydeya comes three months after the Japanese Ministry of Health, Labour and Welfare (JHLW) became the first regulator in the world to back the therapy.

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XTalks

DECEMBER 12, 2023

After receiving US Food and Drug Administration (FDA) approval for Fabhalta (iptacopan) last week for the treatment of the rare blood disorder paroxysmal nocturnal hemoglobinuria (PNH), Novartis presented trial data yesterday showing the drug’s promise in another indication.

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pharmaphorum

SEPTEMBER 16, 2021

Takeda has had a run of bad luck with its Wave1 pipeline of new drug candidates of late, but can now celebrate a vestry after getting FDA approval for first-in-class lung cancer therapy Exkivity. The post Takeda gets a win for its Wave1 pipeline, as Exkivity nabs FDA approval appeared first on.

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FDA Law Blog

NOVEMBER 10, 2024

We note that the only Phase 3 study funded in the FY2024 announcement is the first-ever late-stage clinical trial for the indication of microcystic lymphatic malformations , a serious, rare genetic skin disease with no FDA-approved therapies. Relative to other areas of medicine (e.g.,

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pharmaphorum

AUGUST 16, 2021

Pfizer and BioNTech have formally asked for FDA approval of a third dose of their COVID-19 vaccine BNT162b2 in people aged over 16, as the US prepares to get its booster campaign underway. The post Pfizer, BioNTech file for FDA approval of COVID booster shot appeared first on.

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pharmaphorum

OCTOBER 18, 2024

AbbVie has finally claimed FDA approval for its 24-hour Parkinson's therapy Vyalev, 18 months after the US regulator turned it down

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BioPharma Reporter

AUGUST 22, 2024

The US regulator has confirmed a delay to the approval of linvoseltamab while a manufacturing issue is resolved with a third-party provider.

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XTalks

SEPTEMBER 12, 2022

Sanofi picked up its first Xenpozyme approval for the treatment of Niemann-Pick from Japanese regulators in March followed by an approval from European officials in May. The FDA approval was based on data from the randomized, double-blind, placebo-controlled ASCEND study involving 31 adult patients.

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XTalks

MARCH 28, 2024

Italy-based drugmaker Italfarmaco has won US Food and Drug Administration (FDA) approval for its oral medication Duvyzat (givinostat) for the treatment of Duchenne muscular dystrophy (DMD) in patients six years of age and older. Duvyzat received Priority Review, Orphan Drug and Rare Pediatric Disease designations from the FDA.

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Fierce Pharma

OCTOBER 11, 2024

Six months after scoring FDA approval for hemophilia B gene therapy Beqvez, Pf | For the second time in six months, the FDA approved a Pfizer treatment for hemophilia. regulator signed off on Hympavzi, an anti-tissue factor pathway inhibitor for patients age 12 and older with hemophilia A or B. On Friday the U.S.

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BioSpace

OCTOBER 10, 2021

It is also working to submit applications to other regulators worldwide. If authorized, it could be available in the U.S. before the end of the year.

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Fierce Pharma

FEBRUARY 14, 2024

The FDA has approved the first medicine for severe frostbite. regulator has signed off on Johnson & Johnson’s Aurlumyn (iloprost), an injected treatment to reduce the risk of amputation of the fingers or toes.

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Advarra

JULY 26, 2022

Importantly, the 2018 Farm Bill preserved FDA authority to regulate products with cannabis or cannabis-derived compounds under the Federal Food, Drug, and Cosmetic (FD&C) Act and Section 351 of the Public Health Service Act. The post CBD Research: A Dive into the Regulations of Cannabis Research appeared first on Advarra.

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BioSpace

SEPTEMBER 28, 2023

Thursday’s approval comes after the FDA pushed back the target action dates for Amicus’ Biologics License Application in May, allowing the regulator more time to review the company’s submitted data.

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Fierce Pharma

MAY 14, 2024

It’s been a long wait for Ascendis Pharma to score FDA approval for its hormone replacement therapy TransCon PTH (palopegteriparatide). It’s been a long wait for Ascendis Pharma to score FDA approval for its hormone replacement therapy TransCon PTH (palopegteriparatide).

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BioSpace

OCTOBER 23, 2023

The regulator has approved the first-ever subcutaneous version of infliximab, an IgG1 monoclonal antibody, commonly sold by Johnson & Johnson under the brand name Remicade.

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pharmaphorum

AUGUST 4, 2021

The withdrawals – while voluntary – come as the FDA has been taking a closer look at accelerated approvals of cancer drugs, focusing mainly on checkpoint inhibitors that have seen new uses added to their labels at breakneck speed since being launched onto the market.

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STAT News

JULY 11, 2022

HRA Pharma’s application on Monday sets up a high-stakes decision for health regulators amid legal and political battles over women’s reproductive health. WASHINGTON — For the first time, a pharmaceutical company has asked for permission to sell a birth control pill over the counter in the U.S.

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BioSpace

AUGUST 30, 2023

Amid a supply shortage of the attention-deficit/hyperactivity disorder and binge-eating disorder medication, the regulator has cleared a slew of generic drugs of Takeda’s Vyvanse pill.

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BioSpace

DECEMBER 19, 2023

Tuesday’s approval comes nearly two years after an initial rejection by the regulator. Chiesi Global Rare Diseases gained access to the Filsuvez topical gel in January 2023, when it bought Amryt Pharma.

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BioSpace

NOVEMBER 16, 2023

The company's Truqap, in combination with its endocrine therapy Faslodex, has been approved by the regulator for adult patients with advanced HR-positive breast cancer with specific biomarker alterations.

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