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FDA approves first microbiota-based treatment

Bio Pharma Dive

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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FDA approves cancer drugs from Lilly, Menarini

Bio Pharma Dive

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

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Ferring wins FDA approval for bladder cancer gene therapy

Bio Pharma Dive

The OK caps a long development journey for the treatment, which was previously turned back by the agency. Ferring doesn’t expect it to be available until the second half of next year, however

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FDA approves first gene therapy for hemophilia B

Bio Pharma Dive

The treatment, which is for the less common “B” form of the bleeding disorder, will be sold in the U.S. by maker CSL for $3.5 million

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GSK secures FDA approval of anemia drug, but with limitations

Bio Pharma Dive

The approval is a win for GSK as the FDA had previously rejected two similar drugs from Akebia Therapeutics and Fibrogen. But it comes with restrictions on its use and a safety warning

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FDA approves Adstiladrin as first gene therapy for NMIBC

Pharma Phorum

Dr Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research, said: “This approval provides healthcare professionals with an innovative treatment option for [these] patients.”. The post FDA approves Adstiladrin as first gene therapy for NMIBC appeared first on.

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FDA approves Rezvoglar as second ‘interchangeable’ insulin biosimilar

Bio Pharma Dive

Eli Lilly’s long-acting copycat drug, first approved in late 2021, now has a designation that will allow pharmacists to swap it for Sanofi’s Lantus

Insulin 231
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Federal watchdog highlights flaws in speedy FDA approvals

Bio Pharma Dive

A newly published report by the HHS inspector general found that a substantial number of drugs given an accelerated approval by the FDA still haven’t proven whether they help patients

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Jaypirca (pirtobrutinib) Is Now FDA Approved to Treat Relapsed or Refractory Mantle Cell Lymphoma

XTalks

The decision was based on the results from a Phase I/II study, and continued approval is dependent upon the results of a confirmatory Phase III trial. Different types of TKIs have been approved to treat multiple cancers, including blood cancers.

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US FDA approves Ferring’s Rebyota for Clostridioides difficile infection

Pharmaceutical Technology

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.

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FDA approves new vitiligo treatment, bolstering Incyte's dermatology business

Bio Pharma Dive

The cream, known as Opzelura, is now the only treatment approved in the U.S. to repigment skin in patients with the most common form of vitiligo

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

Bio Pharma Dive

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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Lilly wins FDA approval of new kind of diabetes drug

Bio Pharma Dive

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

Bio Pharma Dive

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

Pharmaceutical Technology

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.

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Briumvi is FDA Approved for Relapsing Forms of Multiple Sclerosis

XTalks

Last week, the FDA approved a new infusible medication from TG Therapeutics for adults with relapsing forms of multiple sclerosis (MS), which include clinically isolated syndrome (CIS), relapsing-remitting (RR) MS, and active secondary progressive MS (SPMS).

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

Pharmaceutical Technology

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.

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FDA approves AstraZeneca, Daiichi drug in breast cancer first

Bio Pharma Dive

Enhertu is the first targeted treatment cleared for breast cancers that are ‘HER2 low,’ a new classification that could change how doctors treat the disease

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US FDA approves Ellipses Pharma’s IND for AML therapy 

Pharmaceutical Technology

The US Food and Drug Administration (FDA) has granted approval for Ellipses Pharma’s investigational new drug (IND) application for EP0042 to treat acute myeloid leukaemia (AML). The post US FDA approves Ellipses Pharma’s IND for AML therapy appeared first on Pharmaceutical Technology.

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Brukinsa (zanubrutinib) Gets FDA Approval for Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma

XTalks

The US Food and Drug Administration (FDA) recently granted approval for the Bruton tyrosine kinase inhibitor (BTKi) Brukinsa (zanubrutinib) based on the results from two Phase III clinical trials. This is the fourth US FDA approval that BeiGene has received for Brukinsa since 2019.

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Axsome rebounds to win FDA approval of depression drug

Bio Pharma Dive

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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CPhI Report forecasts explosion of contract services growth due to surging INDs and 75 FDA approvals by 2025

Pharma Mirror

The report anticipates breakthroughs in multi-modal disease therapies within five years, mRNA platforms to transform many new non-infectious disease treatment options, and huge growth in contract services due to the recent surge in IND applications – with 75 annual FDA approvals expected by 2025.

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US FDA approves Provention Bio’s Tzield to delay diabetes

Pharmaceutical Technology

The US Food and Drug Administration (FDA) has approved Provention Bio’s biologics licence application (BLA) for Tzield (teplizumab-mzwv) to treat type 1 diabetes (T1D) patients.

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Novo Nordisk diabetes pill wins FDA approval for first-line use

Bio Pharma Dive

The approval could help Rybelsus compete with oral drugs marketed by Eli Lilly, Merck & Co. and others

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Lung Disease Diagnostic Xenoview Gets FDA Approval for Use with MRI

XTalks

Medical imaging tech company Polarean Imaging has recently announced that the US Food and Drug Administration (FDA) has approved their drug-device combination product Xenoview (xenon Xe 129 hyerpolarized). Two More Devices Approved by the FDA Alongside Xenoview.

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Roche gets FDA approval for HER2 breast cancer diagnostic

Pharma Phorum

The FDA has approved Swiss pharmaceutical company Roche’s first companion diagnostic for identifying those patients with HER2 low-metastatic breast cancer who are eligible for ENHERTU. The post Roche gets FDA approval for HER2 breast cancer diagnostic appeared first on.

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Lilly’s Jaypirca received FDA approval to treat MCL

Pharmaceutical Technology

Eli Lilly and Company ’s (Lilly) oncology unit Loxo@Lilly has secured the US Food and Drug Administration (FDA) approval for Jaypirca (pirtobrutinib) to treat relapsed or refractory mantle cell lymphoma (MCL).

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Jesduvroq (daprodustat) is FDA Approved for Anemia due to Chronic Kidney Disease

XTalks

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).

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

Bio Pharma Dive

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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5 FDA approval decisions to watch in the first quarter

Bio Pharma Dive

The first three months of 2022 could bring clearances for a new type of immunotherapy and a first-of-its kind HIV drug as well as mark the start of a price battle in oncology

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MediWound’s NexoBrid is FDA Approved for the Treatment of Severe Thermal Burns

XTalks

NexoBrid was already approved for use in 43 countries, including the European Union, India, Japan and others. This US FDA approval of NexoBrid validates our enzymatic technology platform. million milestone payment from Vericel due to the recent FDA approval of NexoBrid.

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

Bio Pharma Dive

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

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FDA approves oral version of Mitsubishi's ALS drug

Bio Pharma Dive

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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US FDA approves Pfizer-BioNTech’s Covid-19 vaccine for adolescents

Pharmaceutical Technology

The US Food and Drug Administration (FDA) has granted approval for Pfizer and BioNTech’s supplemental Biologics License Application (sBLA) for their Covid-19 vaccine, Comirnaty, for adolescents aged 12 to 15 years.

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5 FDA approval decisions to watch in the fourth quarter

Bio Pharma Dive

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 of Biogen Alzheimer’s drug was ‘rife with irregularities,’ congressional report says

Bio Pharma Dive

An investigation by two House committees concluded the FDA failed to document all its meetings with Biogen, and shifted to consider an accelerated clearance on a “substantially abbreviated timeline

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FDA approves bluebird bio’s Skysona to treat cerebral adrenoleukodystrophy

Pharmaceutical Technology

The US Food and Drug Administration (FDA) has awarded Accelerated Approval for bluebird bio ’s Skysona (elivaldogene autotemcel; eli-cel) for slowing neurologic dysfunction progression in early, active cerebral adrenoleukodystrophy (CALD) patients.

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Terlivaz (terlipressin) Injection Gets FDA Approval to Treat Hepatorenal Syndrome

XTalks

Recently, Mallinckrodt announced that Terlivaz (terlipressin) has been approved by the US Food and Drug Administration (FDA) to treat adult patients with hepatorenal syndrome (HRS) with rapid reduction in kidney function.

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Bluebird wins FDA approval of gene therapy for rare brain disorder

Bio Pharma Dive

The therapy, called Skysona and cleared to treat cerebral adrenoleukodystrophy, is the product of more than a decade of work by Bluebird. It will cost $3 million

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

Bio Pharma Dive

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

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Sunlenca (lenacapavir) Receives FDA Approval as HIV Treatment Option for Multi-Drug Resistant Infection

XTalks

recently announced in a press release that Sunlenca (lenacapavir) received approval from the US Food and Drug Administration (FDA) for use as a twice-yearly treatment option for people living with multi-drug resistant HIV (human immunodeficiency virus). Gilead Sciences, Inc.

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US FDA approves Luye Pharma’s schizophrenia treatment Rykindo

Pharmaceutical Technology

The US Food and Drug Administration (FDA) has approved Luye Pharma Group’s Rykindo (risperidone) as an extended-release injectable suspension to treat schizophrenia in adult patients. In 2021, Rykindo was approved to treat schizophrenia in China.

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FDA Approves First Fecal Matter Therapy + PureTech Reveals New CBD Oral Capsule – Xtalks Life Science Podcast Ep. 89

XTalks

In this episode, Ayesha talked about the FDA approval of Ferring Pharmaceuticals’ fecal matter-based therapy Rebyota for the treatment of recurrent C. Hear more about the drug and its approval in this episode.