Outsourcing Pharma

APRIL 5, 2032

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 52

Pharma Phorum

SEPTEMBER 28, 2022

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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Pharma Phorum

DECEMBER 19, 2022

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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Pharmafile

MARCH 17, 2023

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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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.

Dosage

Pharma Phorum

JULY 6, 2022

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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Pharma Phorum

SEPTEMBER 28, 2020

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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Pharma Phorum

JUNE 30, 2022

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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Pharma Phorum

OCTOBER 4, 2022

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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Fierce Pharma

FEBRUARY 28, 2023

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

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Pharma Phorum

MAY 18, 2022

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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Pharma Phorum

JUNE 10, 2022

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 Documentation 133

Pharmafile

MARCH 27, 2023

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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Pharma Phorum

SEPTEMBER 30, 2022

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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Pharma Phorum

DECEMBER 6, 2022

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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Pharma Phorum

DECEMBER 24, 2021

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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PharmaVoice

MARCH 6, 2023

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

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FDA 98

Pharma Phorum

MARCH 31, 2022

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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FDA 98

Fierce Pharma

FEBRUARY 17, 2023

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

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FDA 116

Fierce Pharma

MARCH 22, 2023

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 126

Pharmafile

MARCH 10, 2023

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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FDA Communication 64

Pharmafile

MARCH 23, 2023

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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FDA 59

Fierce Pharma

DECEMBER 29, 2022

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

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Pharma Phorum

NOVEMBER 1, 2021

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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Pharma Tutor

FEBRUARY 2, 2023

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 52

Pharma Phorum

SEPTEMBER 1, 2021

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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Pharmafile

MARCH 22, 2023

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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Pharmafile

MARCH 23, 2023

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 Communication 59

Pharma Phorum

MARCH 11, 2021

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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Pharma Phorum

JANUARY 25, 2023

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 59

Fierce Healthcare

JANUARY 27, 2023

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

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Pharma Phorum

JANUARY 24, 2022

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 98

Pharma Phorum

JANUARY 5, 2021

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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Fierce Pharma

MARCH 23, 2023

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

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FDA 59

Pharma Phorum

DECEMBER 30, 2022

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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Pharma Phorum

JULY 6, 2021

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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Pharma Phorum

OCTOBER 31, 2021

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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Pharma Phorum

SEPTEMBER 2, 2021

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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Pharma Phorum

NOVEMBER 16, 2022

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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Pharma Phorum

JUNE 14, 2022

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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Pharmafile

MARCH 24, 2023

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 Communication 90

Fierce Pharma

MARCH 7, 2023

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

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FDA 88

Pharma Phorum

DECEMBER 23, 2021

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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