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Noxopharm cancer drug secures Orphan Drug Designation from FDA

Outsourcing Pharma

The Australian biotechnology company has been granted ODD status from the agency for Veyonda, a therapy intended for the treatment of soft-tissue sarcoma. Markets & Regulations

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FDA drops PreCert report, new digital health guidances

Pharma Phorum

The US FDA’s Center for Devices and Radiological Health (CDRH) dropped a bevy of new digital health guidances and reports today and yesterday, providing some long-awaited clarity and peeks into the agency’s future plans. .

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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 Novartis’ Tafinlar and Mekinist combination

Pharmafile

The FDA has approved Novartis’ combination therapy, Tafinlar (dabrafenib) and Mekinist (trametinib) for the treatment of BRAF V600E low-grade glioma (LGG) in paediatric patients over the age of one.

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What the FDA's New Dosage Guidance Means for the Future of Clinical Research

Speaker: Dr. Ben Locwin - Biopharmaceutical Executive & Healthcare Futurist

This webinar will go over the FDA's guidance on pharmacological and toxicological considerations for optimizing doses for prescription drugs.

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FDA backs pharmacist prescribing of Paxlovid for COVID

Pharma Phorum

Some patients with COVID-19 will be able to get easier access to Pfizer’s oral antiviral therapy Paxlovid, after the FDA ruled that pharmacists would be able to prescribe the drug. The FDA’s amendment to the EUA comes as Pfizer has just filed for full approval of Paxlovid.

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FDA launches Digital Health Center of Excellence

Pharma Phorum

The FDA has launched its Digital Health Center of Excellence (DHCoE), as the agency continues with its commitment to advancing use of technology such as mobile health devices, software and wearables to create medical products. Digital News digital health fda regulation

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FDA rejection of Spero’s tebipenem ‘raises resistance threat’

Pharma Phorum

The FDA’s decision not to approve Spero Therapeutics’ oral antibiotic tebipenem Hbr for adults with complicated urinary tract infections (cUTI) further increases the threat of antibiotic resistance, according to a GlobalData analyst.

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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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FDA turns down Cytokinetics’ once-promising heart failure drug omecamtiv

Fierce Pharma

FDA turns down Cytokinetics’ once-promising heart failure drug omecamtiv kdunleavy Tue, 02/28/2023 - 18:55

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Google gives ex-FDA digital health head Bakul Patel strategic role

Pharma Phorum

FDA veteran Bakul Patel has joined Google as its new senior director of global digital health strategy, ending a stint at the regulator that lasted more than 13 years. The post Google gives ex-FDA digital health head Bakul Patel strategic role appeared first on.

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Four things you need to know about FDA regulations and digital health

Pharma Phorum

If you work in pharma, the chances are you’re no stranger to the United States Food and Drug Administration, or FDA, which regulates pharmaceuticals. In fact, the FDA’s definition of a medical device specifically excludes drugs. “A FDA has sought to address this in different ways.

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FDA releases draft of accelerated approval guidance for oncology therapeutics

Pharmafile

The FDA has released a draft of new guidance for accelerated approval for oncology therapeutics, highlighting the need for stricter clinical trial design.

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Relief for Amylyx as FDA clears controversial ALS drug Relyvrio

Pharma Phorum

Patient organisations have been celebrating the FDA approval yesterday of Amylyx’ amyotrophic lateral sclerosis (ALS) therapy Relyvrio, after not one but two advisory committee meetings that arrived at different conclusions about the drug.

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Pfizer, BioNTech submit to FDA for Covid vaccine in under 5s

Pharma Phorum

It is also FDA-authorised under an EUA as a third primary series dose in individuals 12 years old and above who have certain kinds of immunocompromises. The post Pfizer, BioNTech submit to FDA for Covid vaccine in under 5s appeared first on.

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Biogen, Eisai Alzheimer’s drug lecanemab fast tracked by FDA

Pharma Phorum

Biogen and Eisai head towards the end of the year with some much-needed good news in their Alzheimer’s programmes, as the FDA awards a fast-track designation to lecanemab, their follow-up to recently approved Aduhelm.

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FDA ups generics and biosimilar approvals for a shot at lower drug costs

PharmaVoice

As the Biden administration searched for drug-cost reducing measures, the FDA incentivized generic and biosimilar development in 2022

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Patients dismayed as FDA advisors narrowly reject Amylyx’ ALS drug

Pharma Phorum

By a narrow margin, an FDA advisory committee has voted against approval of Amylyx’ experimental medicine for amyotrophic lateral sclerosis until the company can provide more evidence that it is effective.

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Apellis wins FDA approval for first geographic atrophy drug

Fierce Pharma

Apellis wins FDA approval for first geographic atrophy drug fkansteiner Fri, 02/17/2023 - 18:06

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AbbVie's blockbuster-to-be Parkinson's combo hits a wall as FDA questions delivery pump

Fierce Pharma

AbbVie's blockbuster-to-be Parkinson's combo hits a wall as FDA questions delivery pump aliu Wed, 03/22/2023 - 11:17

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FDA committee supports Roche’s lymphoma treatment

Pharmafile

A committee at the FDA have voted in favour of Roche’s Polivy antibody drug targeting untreated diffuse large B cell lymphoma, which is the most common form of non-Hodgkin lymphoma in the US.

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Biogen shares FDA decisions on ALS drug

Pharmafile

US-based Biogen has announced two decisions the FDA’s Peripheral and Central Nervous System Drugs Advisory Committee made surrounding its ALS drug, tofersen. The FDA will continue its review of tofersen with a Prescription Drug User Fee Act action date of 25 April, 2023.

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Biogen, FDA's inappropriate Aduhelm coordination detailed in blistering congressional report

Fierce Pharma

Biogen, FDA's inappropriate Aduhelm coordination detailed in blistering congressional report. aarmstrong. Thu, 12/29/2022 - 14:42

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Novartis’ ‘wild card’ drug Scemblix gets FDA nod for leukaemia

Pharma Phorum

Novartis has claimed FDA approval for one of its ‘wild card’ drugs – Scemblix – a first-in-class STAMP inhibitor for patients with previously-treated chronic myeloid leukaemia (CML).

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FDA Inspections - Overview

Pharma Tutor

FDA Inspections - Overview admin Thu, 02/02/2023 - 13:52 FDA Inspection is a regulatory process conducted by the United States Food and Drug Administration (FDA) to evaluate the compliance of food and drug establishments with FDA regulations and standards.

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FDA clears J&J’s twice-yearly Invega for schizophrenia

Pharma Phorum

The FDA has just approved Janssen’s Invega Hafyera (paliperidone), a twice-yearly injectable formulation that extends the company’s big-selling brand and offers the fewest doses per year of any schizophrenia medicine.

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Faron Pharmaceuticals announces positive FDA feedback for solid tumour therapy

Pharmafile

Faron Pharmaceuticals, a clinical stage biopharmaceutical company, has revealed positive FDA feedback and recommendations for its monotherapy for solid tumour drug, bexmarilimab.

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Incyte has announced FDA approval of Zynyz

Pharmafile

Incyte has today announced that the FDA gas approved Zynyz (retifanlimab-dlwr) for the treatment of adult patients with metastatic or recurrent locally advanced Merkel cell carcinoma (MCC).

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FDA fast tracks type 1 diabetes cell therapy from Vertex

Pharma Phorum

Vertex Pharma has made its name with treatment for cystic fibrosis, but has big plans in cell and genetic therapies – and has just chalked up fast-track status from the FDA for a cell-based therapy for diabetes. .

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Automated insulin dosing app Tidepool Loop FDA-cleared

Pharma Phorum

Tidepool, an open-source diabetes non-profit founded in 2013 and driving community-led innovation, has thus made a reality the patient-led project, Tidepool Loop – the first iPhone-controlled interoperable automated glycaemic controller for T1D management of its kind to be given FDA clearance.

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FDA panel approves path toward one-shot yearly COVID vaccine

Fierce Healthcare

FDA panel approves path toward one-shot yearly COVID vaccine fdiamond Fri, 01/27/2023 - 09:17

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FDA clears Gilead’s Veklury for COVID outpatients

Pharma Phorum

The FDA has extended the emergency use authorisation for Gilead Sciences’ antiviral Veklury to include non-hospitalised patients with COVID-19, extending the uses of the drug. The post FDA clears Gilead’s Veklury for COVID outpatients appeared first on.

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FDA and doctors warn against extending COVID-19 vaccine dose gap

Pharma Phorum

Tinkering with the dosing schedule of COVID-19 vaccines runs a “significant risk” to public health, the FDA has warned in a statement after the UK announced plans to prioritise the first doses of two approved shots. Market Access News AstraZeneca COVID-19 fda JCVI vaccine

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Cidara gains first FDA approval, $20M milestone payment as FDA endorses Rezzayo

Fierce Pharma

Cidara gains first FDA approval, $20M milestone payment as FDA endorses Rezzayo kdunleavy Thu, 03/23/2023 - 10:51

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FDA “collaborated” with Biogen on Aduhelm approval, says inquiry

Pharma Phorum

The FDA’s interactions with Biogen in the build-up to last year’s controversial approval of Alzheimer’s disease therapy Aduhelm have been described as “inappropriate” and “atypical” in a congressional report on the review.

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Novartis tries to rescue stalled inclisiran filing with FDA

Pharma Phorum

Novartis has tried to get its marketing application for high cholesterol therapy inclisiran in the US back on track, after the FDA rejected it last year, by changing the factory that makes the drug. The post Novartis tries to rescue stalled inclisiran filing with FDA appeared first on.

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AbbVie claims first FDA okay for presbyopia drug therapy

Pharma Phorum

The FDA has approved the first and so far only pharmacological treatment for presbyopia, a sight condition that typically starts in middle age and involves difficulty in focusing on near objects. The post AbbVie claims first FDA okay for presbyopia drug therapy appeared first on.

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FDA schedules adcomm for Pfizer’s COVID booster filing

Pharma Phorum

The FDA will hold an advisory committee meeting later this month to discuss Pfizer and BioNTech’s filing for approval of a third booster dose of their COVID-19 vaccine Comirnaty in people aged 16 and over. Market Access News BioNTech COVID-19 COVID-19 vaccine fda Pfizer

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ImmunoGen ELAHERE wins accelerated FDA approval for ovarian cancer

Pharma Phorum

has announced that its platinum-resistant ovarian cancer drug ELAHERE (mirvetuximab soravtansine-gynx) has been granted FDA accelerated approval. The post ImmunoGen ELAHERE wins accelerated FDA approval for ovarian cancer appeared first on. ImmunoGen, Inc.

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FDA’s treatment of China-developed drugs spurs demands for multiregional clinical trials

Pharma Phorum

Despite more treatment options being a positive, Ben Hargreaves finds that this has raised issues over single-region clinical trials, leading to the FDA rejecting certain treatments and clarifying what is required for approval.

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NeuroRPM announces FDA clearance for AI monitoring app for Parkinson’s disease on Apple Watch

Pharmafile

NeuroRPM has announced that it has received clearance from the FDA for its NeuroRPM device which uses AI and existing Apple Watch technology to monitor symptoms of Parkinson’s disease, offering continuous, day-to-day tracking of symptoms.

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FDA delays BioMarin's gene therapy approval decision by 3 months

Fierce Pharma

FDA delays BioMarin's gene therapy approval decision by 3 months zbecker Tue, 03/07/2023 - 10:41

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FDA sets out its stall on digital tools for remote clinical trials

Pharma Phorum

The FDA has published draft guidance on how digital health technologies (DHTs) like smart and wearable devices can be used to capture data remotely from patients in clinical trials – an approach that has come to the fore since the start of the pandemic.

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