Fierce Pharma

OCTOBER 13, 2023

after a long-awaited FDA approval, the company is struggling with regulatory hurdles overseas. Europe's drug regulator wasn't swayed by Amylyx's phase 2 data. The European Commission will make the final call on the drug's approval in the bloc by the end of the year.

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Regulation FDA Approval Drugs 122

BioSpace

JUNE 14, 2022

A recent study found that over a span of ten years, the FDA approved cancer drugs approximately eight months earlier than the same drugs were greenlit by the European Commission (EC).

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FDA Approval Regulation Drugs 98

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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FDA Approval Regulation Drugs 265

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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Bio Pharma Dive

OCTOBER 1, 2021

Regulators face key decisions on COVID-19 shots for children and boosters for Moderna's and J&J's vaccines. Other closely watched drugs for multiple myeloma and depression are under review, too.

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FDA Approval Regulation Vaccination Vaccine 323

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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FDA Approval Trials Regulation Drugs 147

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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BioSpace

APRIL 24, 2024

The regulator on Wednesday gave its approval for a new oral antibiotic to treat uncomplicated urinary tract infections in women. UTILITY therapeutics expects to launch Pivya in the U.S.

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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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FDA Approval Cardiology Clinical Trials Clinical Trials 246

Fierce Pharma

APRIL 4, 2024

Fifteen years after Basilea's antibiotic ceftobiprole sustained a rejection from the FDA, the company has finally won over the U.S. regulator and done so in triplicate. | Fifteen years after Basilea's antibiotic ceftobiprole sustained a rejection from the FDA, the company has finally won over the U.S.

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FDA Approval Regulation 101

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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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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FDA Approval Drugs Regulation 330

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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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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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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FDA Approval Gene Therapy Genetic Disease Gene 130

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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FDA Approval Regulation Medicine 121

BioSpace

DECEMBER 14, 2023

Despite the lack of a randomized clinical trial to support eflornithine’s efficacy, the regulator approved US WorldMeds’ oral maintenance treatment for high-risk neuroblastoma in adults and children.

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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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FDA Approval Regulation 117

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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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

MARCH 19, 2024

Twelve years after Takeda's Iclusig (ponatinib) earned a restricted FDA approval to treat certain patients with Philadelphia chromosome-positive acute lymphoblastic leukemia (Ph+ALL), the U.S. regulator has signed off on a wider use.

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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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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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BioSpace

NOVEMBER 7, 2023

After winning traditional approval from the U.S. regulator, Eisai’s Alzheimer’s disease therapy Leqembi has seen a sharp increase in patient uptake, with a target of 10,000 patients by March 2024.

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FDA Approval Regulation 109

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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FDA Approval Generic Drugs Drugs Regulation 111

BioSpace

OCTOBER 12, 2023

The regulator's approval of oral, once-daily etrasimod, to be marketed as Velsipity, was based on favorable Phase III safety and efficacy data showing significant clinical remission of ulcerative colitis.

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FDA Approval Regulation Drugs Marketing 111

BioSpace

OCTOBER 29, 2023

Loqtorzi is the first programmed death receptor-1 from China to be approved by the U.S. regulator, and the first for patients with recurrent or metastatic nasopharyngeal carcinoma across all lines of treatment.

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BioSpace

AUGUST 24, 2023

Amid one of the industry’s steepest patent cliffs, the regulator Thursday approved Sandoz’s Tyruko, the first biosimilar for treating relapsing multiple sclerosis in adults. Sandoz is a division of Novartis.

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FDA Approval Regulation 98

BioSpace

AUGUST 16, 2023

After two prior setbacks, the regulator has finally approved Ipsen’s palovarotene to treat fibrodysplasia ossificans progressiva. It’s the first treatment for the ultra-rare bone disease.

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FDA Approval Regulation 98

pharmaphorum

JANUARY 26, 2022

Immunocore has secured a piece of biotech industry history, becoming the first company to get an FDA approval for a cancer therapeutic based on T cell receptor (TCR) technology. The post Immunocore claims first-ever FDA approval for TCR cancer therapy appeared first on.

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Pharmaceutical Technology

MAY 10, 2023

The US Food and Drug Administration (FDA) has granted approval for AstraZeneca ’s Farxiga (dapagliflozin) to reduce the risks of cardiovascular (CV) death, hospitalisation for heart failure (hHF) and urgent heart failure (HF) emergency care visits in HF adult patients.

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FDA Approval Regulation Trials Drugs 130

Fierce Pharma

DECEMBER 20, 2023

Seven months after Krystal Biotech became the first company to gain FDA approval to treat the rare, devastating skin disease epidermolysis bullosa (EB), Chiesi Farmaceutici has followed suit. On Tuesday, the U.S.

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FDA Approval Regulation 128

BioPharma Reporter

JULY 29, 2021

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

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FDA Approval Drugs Regulation Marketing 98

Drug Discovery World

AUGUST 21, 2023

The FDA approval is based on data from the Phase III MOVE trial, which demonstrated that palovarotene effectively reduced annualised heterotopic ossification (HO) volume compared with no treatment beyond standard of care (54% reduction with weighted linear mixed effect model).

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FDA Approval Medicine Drugs Regulation 52

Fierce Pharma

NOVEMBER 2, 2023

. | In a span of three days, Phathom Pharmaceuticals has scored two green lights from the FDA for its first-in-class heartburn drug Voquezna. The first came on Monday when the regulator signed off on Phathom’s reformulation of Voquezna to treat Helicobacter pylori infection.

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FDA Approval Regulation Drugs 106

BioSpace

DECEMBER 7, 2023

Along with CRISPR/Cas9-based Casgevy—developed by Vertex Pharmaceuticals and CRISPR Therapeutics—the regulator on Friday approved bluebird bio’s Lyfgenia, a second gene therapy for sickle cell disease.

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Gene Therapy Gene FDA Approval Regulation 85

BioSpace

JULY 12, 2023

The regulator on Thursday approved Opill, the first oral contraceptive available in the U.S. without a prescription. Perrigo shares rose 6% in response to the news.

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FDA Approval Regulation 98