Pharmaceutical Technology

AUGUST 8, 2024

Novartis has secured US Food and Drug Administration (FDA) accelerated approval for Fabhalta (iptacopan) to treat igAN.

Food and Drug Administration 105

Food and Drug Administration FDA Food 105

World of DTC Marketing

FEBRUARY 1, 2022

Meanwhile, the Food and Drug Administration has delayed several drug approvals, and Sen. introduced sweeping drug-pricing legislation. 1ne: More scrutinization by the FDA on new drug applications. Launching a new drug is getting harder, especially if it doesn’t have blockbuster potential.

Food and Drug Administration 234

Food and Drug Administration FDA Pharmaceutical Food 234

European Pharmaceutical Review

JANUARY 16, 2023

Under the agreement with the Swiss Confederation (Switzerland), the Swiss Agency for Therapeutic Products (Swissmedic) and the US Food and Drug Administration (FDA) will be able to utilise each other’s GMP inspections of pharmaceutical manufacturing facilities, avoiding the need for duplicate inspections.

Food and Drug Administration 122

Food and Drug Administration FDA Manufacturing Food 122

Pharmaceutical Technology

JUNE 3, 2024

Moderna has secured approval from the US Food and Drug Administration (FDA) for mRESVIA (respiratory syncytial virus vaccine).

Food and Drug Administration 98

Food and Drug Administration FDA Food 98

Pharmaceutical Technology

AUGUST 13, 2024

Ascendis Pharma has obtained US Food and Drug Administration (FDA) approval for its YORVIPATH to treat hypoparathyroidism in adults.

Food and Drug Administration 98

Food and Drug Administration FDA Food Pharma 98

pharmaphorum

OCTOBER 4, 2024

Bristol Myers Squibb (BMS) has been granted approval by the US Food and Drug Administration (FDA) for Opdivo to treat adults with resectable non-small cell lung cancer (NSCLC).

Food and Drug Administration 102

Food and Drug Administration FDA Food 102

Pharmaceutical Technology

SEPTEMBER 13, 2024

The US Food and Drug Administration (FDA) has approved Roche's Tecentriq Hybreza, a subcutaneous anti-PD-(L)1 cancer immunotherapy.

Food and Drug Administration 98

Food and Drug Administration FDA Food 98

World of DTC Marketing

DECEMBER 2, 2021

GOOD MORNING: The FDA is taking a scientific approach to evaluating direct-to-consumer (DTC) drug advertising, focusing on measuring consumer perceptions of the information presented in ads. Presenting quantitative information increased participants’ gist and verbatim recall of drug efficacy. ” Uh…no.

Food and Drug Administration 185

Food and Drug Administration Side effects FDA Prescription 185

Pharmaceutical Technology

NOVEMBER 28, 2023

The US Food and Drug Administration (FDA) has accepted to review Orexo’s new drug application (NDA) for opioid overdose medication, OX124.

Food and Drug Administration 105

Food and Drug Administration Medical FDA Food 105

Pharmaceutical Technology

APRIL 29, 2024

Pfizer has received approval from the US Food and Drug Administration (FDA) for its one-time gene therapy BEQVEZ for haemophilia B.

Food and Drug Administration 98

Food and Drug Administration FDA Food 98

Pharmaceutical Technology

NOVEMBER 14, 2024

The US Food and Drug Administration (FDA) has granted accelerated approval for PTC Therapeutics’ KEBILIDI, the first gene therapy in the US that is directly delivered to the brain.

Food and Drug Administration 98

Food and Drug Administration FDA Food 98

Pharmaceutical Technology

OCTOBER 17, 2024

The company’s keratoconus medication, Epioxa, was effective in a Phase III trial, with plans to file for submission with the US Food and Drug Administration (FDA).

Food and Drug Administration 98

Food and Drug Administration FDA Food Medical 98

Pharmaceutical Technology

DECEMBER 19, 2023

Pharmaceutical Technology outlines some of the biggest US Food and Drug Administration (FDA) drug approvals announced in 2023 that are set to make an impact in the coming years.

Food and Drug Administration 105

Food and Drug Administration Food Pharma FDA 105

Pharmaceutical Technology

APRIL 19, 2024

The US Food and Drug Administration (FDA) has granted fast-track designation to Bayer subsidiary Asklepios BioPharmaceutical’s (AskBio) investigational gene therapy AB-1002, aimed at treating congestive heart failure (CHF).

Food and Drug Administration 98

Food and Drug Administration FDA Food 98

Pharmaceutical Technology

MAY 10, 2023

Synlogic has received orphan drug designation (ODD) from the US Food and Drug Administration (FDA) for SYNB1934 to treat phenylketonuria (PKU), a rare inherited metabolic disease. The company stated that its findings support the potential for a safe, flexible, effective and convenient oral treatment option for PKU.

Food and Drug Administration 104

Food and Drug Administration FDA Engineering Medicine 104

World of DTC Marketing

DECEMBER 29, 2020

For the COVID-19 vaccine, the Food and Drug Administration (FDA) set up rigorous standards for vaccine developers to meet. A key consideration is funding – public and private cash has been poured into the race for a Covid vaccine, pushing aside the usual financial concerns facing pharmaceutical companies.

Pharma 307

Pharma Food and Drug Administration Media Food 307

Pharmaceutical Technology

JUNE 19, 2023

UK-based pharmaceutical giant GSK has announced that the US Food and Drug Administration (FDA) has extended the review period of its new drug application (NDA) for the rare bone cancer drug momelotinib by three months. The drug is not currently approved in any markets globally.

Food and Drug Administration 98

Food and Drug Administration FDA Prescription Food 98

Pharmaceutical Technology

MAY 19, 2023

The US Food and Drug Administration (FDA) has granted approval to Bausch + Lomb and Novaliq’s Miebo (perfluorohexyloctane ophthalmic solution) to treat the signs and symptoms of dry eye disease (DED).

Food and Drug Administration 133

Food and Drug Administration FDA Prescription Food 133

Pharmaceutical Technology

DECEMBER 4, 2023

The US Food and Drug Administration (FDA) has granted approval for Ambio’s generic version of Forteo for the treatment of osteoporosis.

Food and Drug Administration 98

Food and Drug Administration FDA Food 98

European Pharmaceutical Review

MAY 11, 2023

The US Food and Drug Administration (FDA) has released a discussion paper to complement and inform future guidance on artificial intelligence (AI) and machine learning (ML) in drug development. The post FDA publishes paper on AI/ML in drug development appeared first on European Pharmaceutical Review.

Food and Drug Administration 104

Food and Drug Administration FDA Pharmaceutical manufacturing Manufacturing 104

World of DTC Marketing

JUNE 22, 2022

A new feature—a sensor that monitors changes in the heart rate for irregularities that can lead to strokes and heart failure—has just been approved by America’s Food and Drug Administration (FDA). The FDA’s stamp of approval for the Fitbit sensor is a big deal. Then there is the cost of generic drugs.

Healthcare 227

Healthcare Healthcare Food and Drug Administration FDA 227

World of DTC Marketing

JULY 15, 2021

SUMMARY: The Committee on Oversight and Reform and the Committee on Energy and Commerce is investigating the approval process for Biogen’s new Alzheimer’s drug. Janet Woodcock acknowledged on Wednesday her agency may have misstepped in the handling of its polarizing approval of a new Alzheimer’s drug.

Food and Drug Administration 202

Food and Drug Administration FDA Side effects Ethics 202

European Pharmaceutical Review

JUNE 21, 2023

The US Food and Drug Administration (FDA) has approved LODOCO ® , the “first drug to target cardiovascular inflammation,” reported Dr Paul Ridker, MPH, Professor of medicine at Harvard Medical School and Director of the Center for Cardiovascular Disease Prevention, Brigham and Women’s Hospital.

Food and Drug Administration 126

Food and Drug Administration Medicine FDA Food 126

European Pharmaceutical Review

JANUARY 25, 2024

Draft guidance published by the US Food and Drug Administration (FDA) in December 2023, discussed quality considerations for topical ophthalmic drug products, including key considerations for extractables and leachables (E&L) testing. This document is revised from a version published in October 2023.

FDA 98

FDA Food and Drug Administration Safety Manufacturing 98

Pharmaceutical Technology

NOVEMBER 18, 2024

The decision in Europe follows an approval granted by the US Food and Drug Administration (FDA) in March this year.

Food and Drug Administration 105

Food and Drug Administration Food FDA 105

European Pharmaceutical Review

JULY 3, 2023

The Office of Pharmaceutical Quality (OPQ) in the US Food and Drug Administration (FDA)’s Center Pharmaceutical Quality for Drug Evaluation and Research (CDER) has released its 2022 annual report analysing drug manufacturers and their products. percent) to be noncompliant.

Food and Drug Administration 105

Food and Drug Administration FDA Manufacturing Product sample 105

Pharmaceutical Technology

NOVEMBER 1, 2024

Verastem Oncology has concluded the rolling submission of a new drug application (NDA) to the US Food and Drug Administration (FDA) for a combination of avutometinib and defactinib for low-grade serous ovarian cancer (LGSOC).

Food and Drug Administration 105

Food and Drug Administration Food FDA 105

World of DTC Marketing

JANUARY 10, 2022

It seems that pharma is only interested in drugs that have the potential to sell hundreds of millions as opposed to small products that may only sell to a limited audience. A study in 2020 estimated that the median cost of getting a new drug into the market was $985 million, and the average price was $1.3 5 drugs) ranged from $765.9

Food and Drug Administration 213

Food and Drug Administration Pharma Marketing Food 213

European Pharmaceutical Review

SEPTEMBER 28, 2023

The US Food and Drug Administration (FDA) has approved Takeda’s single-dose pre-filled pen for ENTYVIO ® (vedolizumab) as a treatment for the chronic inflammatory disease ulcerative colitis. The biologic is approved for intravenous (IV) and subcutaneous (SC) administration.

Food and Drug Administration 104

Food and Drug Administration FDA Physicians Food 104

Pharmaceutical Technology

SEPTEMBER 16, 2024

Roche has secured approval from the US Food and Drug Administration for Ocrevus Zunovo with Halozyme's Enhanze drug delivery technology.

Food and Drug Administration 98

Food and Drug Administration Food FDA 98

Pharmaceutical Technology

JUNE 8, 2023

The US Food Drug Administration (FDA) has granted orphan drug designation to DTx Pharma’s investigational DTx-1252 for the treatment of Charcot-Marie-Tooth disease Type 1A (CMT1A).

Food and Drug Administration 98

Food and Drug Administration FDA Food Manufacturing 98

European Pharmaceutical Review

JANUARY 16, 2023

The US Food and Drug Administration (FDA) has approved Rykindo ® (risperidone) for extended-release injectable suspension. The drug is indicated as a bi-weekly treatment for schizophrenia and as monotherapy or as adjunctive therapy to lithium or valproate for bipolar I disorder in adults.

Food and Drug Administration 122

Food and Drug Administration FDA Competition Pharma 122

Pharmaceutical Technology

JANUARY 17, 2024

Takeda has gained approval from the US Food and Drug Administration for HYQVIA to treat chronic inflammatory demyelinating polyneuropathy.

Food and Drug Administration 98

Food and Drug Administration Food FDA 98

European Pharmaceutical Review

NOVEMBER 22, 2022

a China-based pharma company has announced it has received clearance for its Investigational New Drug (IND) application from the US Food and Drug Administration (FDA) to initiate clinical studies of T21, a 3D-printed medicine that can target specific segments in the colon to more safely deliver oral ulcerative colitis (UC) drugs.

Food and Drug Administration 111

Food and Drug Administration Side effects FDA Medicine 111

World of DTC Marketing

APRIL 12, 2021

The goal of getting a drug to market as fast as possible so they can recoup drug development costs has the potential for mistakes that could cost lives. Coupled with all this is the continued outsourcing of raw materials and other steps in drug development. Up to 90% of drugs now sold in the US and UK are generic.

Food and Drug Administration 187

Food and Drug Administration Prescription Pharma Manufacturing 187

Pharmaceutical Technology

NOVEMBER 28, 2024

The US Food and Drug Administration has declined to approve Applied Therapeutics’ govorestat for classic galactosemia.

Food and Drug Administration 98

Food and Drug Administration Food FDA 98

Pharmaceutical Technology

AUGUST 10, 2022

The US Food and Drug Administration (FDA) has granted Fast-Track designation to Relmada Therapeutics’ REL-1017 as a single agent to treat major depressive disorder (MDD). The post FDA grants Fast-Track status for Relmada’s major depressive disorder therapy appeared first on Pharmaceutical Technology.

Food and Drug Administration 119

Food and Drug Administration FDA Safety Food 119