Pharmaceutical Technology

MAY 29, 2023

Lexicon senior vice president and chief medical officer Dr Craig Granowitz said: “With today’s FDA approval, Inpefa is now a valuable option for physicians to consider when treating patients transitioning out of the hospital and working to break the cycle of repeated hospitalisation.”

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Pharmaceutical Technology

FEBRUARY 2, 2023

In June 2020, Japan’s Ministry of Health, Labour and Welfare approved daprodustat tablets to treat patients with anaemia of CKD. The European Medicines Agency is currently reviewing a marketing authorisation application for daprodustat and a regulatory decision is expected in the first half of this year.

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FDA Approval Life Science Genetics Trials 264

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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Bio Pharma Dive

APRIL 8, 2023

approval, and could carry consequences for the FDA’s authority over prescription medicines. The decision imperils access to the drug more than two decades after its U.S.

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FDA Approval Medicine Drugs 275

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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Fierce Pharma

DECEMBER 8, 2023

| Vertex Pharmaceuticals and CRISPR Therapeutics have won an historic FDA approval for their sickle cell disease gene therapy Casgevy. The transformational treatment is a potential cure for the debilitating and life-threatening disease which affects more than 100,000 in the United States, most of them Black.

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Fierce Pharma

FEBRUARY 7, 2023

Orexo, leveraging drug delivery tech, seeks FDA approval of nasal high-dose opioid rescue medicine ntaylor Tue, 02/07/2023 - 08:18

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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). Ipsen is also seeking marketing approval from the European Medicines Agency, with a final decision expected in the second half of 2023.

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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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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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FDA Approval Drugs Medicine Clinical Trials 193

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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Pharmaceutical Technology

AUGUST 8, 2022

AstraZeneca Oncology Business Unit executive vice-president Dave Fredrickson said: “The rapid approval of Enhertu in HER2-low metastatic breast cancer by the FDA underscores the urgency to bring this transformational medicine to patients as quickly as possible.

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Pharmaceutical Technology

MARCH 27, 2023

It is claimed to be the first and only therapy to receive approval in the US for the treatment of APDS, a rare and progressive primary immunodeficiency. Leniolisib’s marketing authorisation application (MAA) is currently under review with the Committee for Human Medicinal Products (CHMP) of the European Medicines Agency (EMA).

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FDA Approval Clinical Trials Clinical Trials Medicine 130

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. AstraZeneca is also venturing into cell therapy and genetic medicine.

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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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Pharmaceutical Technology

SEPTEMBER 5, 2022

Earlier, the therapy had obtained FDA approval for usage in CF patients aged two years and above with two F508del mutation copies. The latest approval for use in children aged 12 to below 24 months is based on an open-label, multicentre Phase III clinical trial for 24 weeks.

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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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Bio Pharma Dive

APRIL 24, 2023

Submission of the application comes weeks after rivals Vertex and CRISPR filed their gene editing medicine for the disease with the agency.

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Gene Editing Gene Gene Therapy FDA Approval 257

Pharmaceutical Technology

JUNE 21, 2023

With today’s FDA approval of Talzenna plus Xtandi, we are proud to be able to offer this potentially practice-changing treatment to patients and add to their options in managing this aggressive disease.”

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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 Approval Medicine Drugs 275

XTalks

JANUARY 3, 2024

Wainua is the only FDA-approved drug for the treatment of ATTRv-PN that can be self-administered via an auto-injector. Approval of Wainua represents a meaningful advancement in treatment, one that gives those who are living with transthyretin-mediated amyloid polyneuropathy help managing the disease,” said Michael J.

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XTalks

JANUARY 2, 2024

For instance, Vyjuvek , the first FDA-approved gene therapy for DEB, is priced at $24,250 per vial. a biotech company specializing in the development and commercialization of genetic medicines for rare diseases, announced FDA approval for Vyjuvek for the treatment of DEB.

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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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Pharmaceutical Technology

JUNE 21, 2023

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. It has been designed to target residual inflammation as an underlying cause of ASCVD.

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FDA Approval Cardiology Clinical Trials Clinical Trials 246

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.

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FDA Approval Drugs Medicine 180

XTalks

NOVEMBER 30, 2023

Pfizer spinout SpringWorks Therapeutics’ Ogsiveo (nirogacestat) has received US Food and Drug Administration (FDA) approval for the treatment of desmoid tumors, an ultra-rare subtype of non-cancerous soft tissue sarcomas that can cause severe pain and disfigurement.

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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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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. The regulatory approval was supported by data from the GEM-1/2 and GEM-3 clinical trials.

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FDA Approval Gene Therapy Genetic Disease Gene 130

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 Approval Drugs Antibody Medicine 282

XTalks

DECEMBER 18, 2023

Merck received its second US Food and Drug Administration (FDA) approval for its cancer pill Welireg (belzutifan). The oral hypoxia-inducible factor-2 alpha (HIF-2α) inhibitor was first approved in August 2021 for von Hippel-Lindau (VHL), a rare hereditary disease that causes tumor growth in different organs, particularly the kidney.

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BioSpace

NOVEMBER 22, 2022

The FDA approved CSL Behring and uniQure’s Hemgenix, a one-time gene therapy developed for adults with Hemophilia B,the companies announced Tuesday afternoon.

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Pharmaceutical Technology

JUNE 1, 2023

Safety and tolerability were in line with that observed in prior trials and the known profiles of the medicines. In comparison, the rPFS and OS for those on placebo with Zytiga and prednisone was 8 months and 23 months, respectively. A prior orchiectomy or receipt of gonadotropin-releasing hormone (GnRH) analogs was also necessary.

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FDA Approval Hormones Trials Clinical Trials 244

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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FDA Approval Drugs Medicine 267

XTalks

FEBRUARY 6, 2023

GlaxoSmithKline LLC (GSK) recently announced that the US Food and Drug Administration (FDA) approved Jesduvroq (daprodustat), a new once-a-day oral treatment for anemia due to chronic kidney disease (CKD). The approval is currently only for adult patients who have been undergoing dialysis for at least four months.

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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.

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FDA Approval Drugs Medicine 140

Drug Discovery World

MARCH 22, 2024

Michael Weber, Professor of Medicine, Division of Cardiovascular Medicine, State University of New York, and an investigator in the PRECISION study, commented: “Today, we are not able to reduce blood pressure below recommended levels in at least 10% of the hypertensive patients we treat.

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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. The collaboration with Sixth Street has three parts.

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