European Pharmaceutical Review

FEBRUARY 4, 2025

The Medicines and Healthcare products Regulatory Agency (MHRA) has granted approval for SARCLISA (isatuximab), making it the first and only anti-CD38 quadruplet therapy available for patients with newly diagnosed multiple myeloma who are ineligible for autologous stem cell transplant (ASCT).

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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. Rather than have patients fill out the paperwork online and get a specific time for their shot, Florida uses the cattle car mentality, leading to people waiting overnight.

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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.

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Pharmaceutical Technology

APRIL 14, 2023

The US Food and Drug Administration (FDA) has granted rare paediatric drug designations for IPS HEART’s stem cell therapeutics, GIVI-MPC and ISX9-CPC, to treat Duchenne muscular dystrophy (DMD) patients. The drug candidate received an orphan drug designation (ODD) from the FDA in February 2023.

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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). The findings showed that Miebo met its primary clinical sign and patient-reported symptom endpoint.

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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.

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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.

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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.

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World of DTC Marketing

APRIL 12, 2021

QUICK READ: Pharma supply chain issues are a concern for us all but especially patients. 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. Patients should be scared. In other words, money over safety.

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Infuse Medical

JULY 4, 2024

If so, it is important to understand the regulatory requirements of the FDA. Do you know the FDA is the Food and Drug Administration? It is essential to understand the FDA’s definition of a medical device. Let’s see FDA regulations for medical device training.

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Pharmaceutical Technology

MARCH 8, 2023

The US Food and Drug Administration (FDA) has granted approval for Shorla Oncology’s Nelarabine Injection, an oncology drug, to treat T-cell leukaemia, an aggressive blood and bone marrow cancer that progresses quickly. The company develops innovative oncology drugs with a focus on paediatric and orphan cancers.

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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.

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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

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MedCity News

JUNE 12, 2023

The goal was simple: provide access and focused support to patients remotely while simultaneously relieving overtaxed healthcare facilities. Combined, DTx and DCTs improve patient recruitment, retention, and access, allowing researchers to pull from underserved communities, including rural populations.

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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.

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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). It significantly impacts patients’ lives, causing loss of mobility, progressive muscle wasting and neuropathic pain.

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European Pharmaceutical Review

OCTOBER 18, 2023

The US Food and Drug Administration (FDA) has approved XPHOZAH ® (tenapanor), the first and only phosphate absorption inhibitor. Overall, the data showed that XPHOZAH significantly reduced elevated serum phosphorus in patients receiving maintenance hemodialysis.

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European Pharmaceutical Review

FEBRUARY 9, 2023

To date, there are no US Food and Drug Administration (FDA)-approved treatments specifically targeting this disorder. If progress continues in a Phase III clinical trial, this medication would be the first FDA-approved drug specifically for people with notalgia paresthetica. severe itch) in each group.

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Pharmaceutical Technology

JANUARY 22, 2023

Eli Lilly and Company and Boehringer Ingelheim have announced that the US Food and Drug Administration (FDA) accepted a supplemental New Drug Application (sNDA) for Jardiance (empagliflozin) tablets for chronic kidney disease (CKD) in adult patients.

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pharmaphorum

DECEMBER 19, 2022

The US Food and Drug Administration (FDA) has approved Swiss drugmaker Ferring Pharmaceuticals’ Adstiladrin (nadofaragene firedenovec-vncg) for the treatment of adult patients with high-risk Bacillus Calmette-Guérin (BCG)-unresponsive non-muscle-invasive bladder cancer (NMIBC) with carcinoma in situ (CIS), with or without papillary tumours.

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Pharmaceutical Technology

MARCH 2, 2023

The US Food and Drug Administration (FDA) has approved Reata Pharmaceuticals ’ oral, once-daily medication SKYCLARYS (omaveloxolone) to treat Friedreich’s ataxia patients. SKYCLARYS is the first approved treatment in Friedrich’s Ataxia and marks a milestone for drug development in this complex disease.

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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.

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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.

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European Pharmaceutical Review

NOVEMBER 25, 2022

The Luye Pharma drug demonstrated comparable bioavailability with Johnson and Johnson’s Invega Sustenna ® at steady state in a clinical trial ( NCT04922593 ). If successful, the drug is forecasted to reach sales of $63.5 The post Promising schizophrenia drug faces tough competition appeared first on European Pharmaceutical Review.

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Pharmaceutical Technology

APRIL 18, 2023

IntelGenx Corp announced that the US Food and Drug Administration (FDA) has approved the company’s Rizafilm VersaFilm new drug application (NDA) for the treatment of acute migraine. It dissolves rapidly releasing the active ingredient in the mouth, meaning there is no requirement for the patient to swallow a pill.

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Pharmaceutical Technology

MAY 26, 2023

The US Food and Drug Administration (FDA) has granted priority review for Takeda and HUTCHMED’s new drug application (NDA) for fruquintinib. The new drug application (NDA) included data from the Phase III FRESCO-2 and FRESCO trials conducted in China.

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World of DTC Marketing

SEPTEMBER 7, 2022

In pharma, growth depends on new products with hefty price tags when over 80% of voters want lower costs for their prescription drugs. They relied so much on a new drug that they tried to market a product with bad science behind it. The pharma industry is a giant behemoth that needs new drugs to survive and grow.

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European Pharmaceutical Review

OCTOBER 25, 2023

The US Food and Drug Administration (FDA) has approved a new therapy for adults with relapsed or refractory (R/R) myelodysplastic syndromes (MDS) with an isocitrate dehydrogenase-1 (IDH1) mutation, a rare type of blood cancer. The observed complete remission or partial remission rate in this patient group was 39 percent.

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European Pharmaceutical Review

MAY 7, 2024

A novel intravesical targeted drug delivery system for patients with bladder cancer has demonstrated positive data in updated results from a Phase I trial. The treatment is being evaluated in patients with non–muscle-invasive bladder cancer (NMIBC) with select FGFR alterations.

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European Pharmaceutical Review

NOVEMBER 23, 2022

The US Food and Drug Administration (FDA) has approved Hemgenix (etranacogene dezaparvovec), the first gene therapy for adults with Haemophilia B (congenital Factor IX deficiency) who currently use Factor IX prophylaxis therapy, or have current or historical life-threatening haemorrhage, or have repeated, serious spontaneous bleeding episodes.

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Pharmaceutical Technology

JULY 19, 2022

The US Food and Drug Administration (FDA) has granted approval for Incyte’s Opzelura (ruxolitinib) cream 1.5% as a topical treatment of nonsegmental vitiligo in adults and paediatric patients aged 12 years and above. Opzelura is a topical formulation of a Janus kinase (JAK) inhibitor.

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European Pharmaceutical Review

MAY 17, 2024

The US Food and Drug Administration (FDA) has approved Amgen’s Imdelltra (tarlatamab-dlle), a bispecific T-cell engager, for the treatment of adult patients with extensive-stage small cell lung cancer (ES-SCLC). FDA’s approval of Imdelltra was based on results from the Phase II DeLLphi-301 clinical trial.

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Pharmaceutical Technology

FEBRUARY 5, 2023

The US Food and Drug Administration (FDA) has granted approval for Gilead Sciences ’ Trodelvy (sacituzumab govitecan-hziy) to treat unresectable locally advanced or metastatic hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative (IHC 0, IHC 1+ or IHC 2+/ISH–) breast cancer adult patients.

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European Pharmaceutical Review

JANUARY 10, 2023

Clarivate Plc has released its Drugs to Watch 2023 report — among 70 of the drugs highlighted, including potential blockbuster drugs, the majority were revealed to be personalised medicines. The report offers predictive analysis of drugs entering the market or launching key indications in 2023.

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European Pharmaceutical Review

JANUARY 20, 2023

The US Food and Drug Administration (FDA) has issued a complete response letter for the accelerated approval submission of donanemab for early Alzheimer’s, Eli Lilly and Company revealed. Lilly confirmed that the Phase III trial included more than 100 patients treated with donanemab.

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European Pharmaceutical Review

MAY 19, 2023

This finding alongside the other data from the trial led the US Food and Drug Administration (FDA)’s Antimicrobial Drugs Advisory Committee to recommend the FDA approve the combination antibiotic for often-fatal pneumonia strain carbapenem-resistant Acinetobacter baumannii–calcoaceticus complex (ABC).

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European Pharmaceutical Review

FEBRUARY 22, 2023

The hurdles encountered in development and approval of a new drug can be overwhelming. 1 Consequently, the US Food and Drug Administration (FDA) and other agencies are keen to see “accelerated development” programmes in areas where there is a significant unmet clinical need. billion, and rising.

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