European Pharmaceutical Review

NOVEMBER 18, 2022

Tzield (teplizumab-mzwv), the first drug to help prolong the onset of stage 3 type 1 diabetes in adults and children over eight years old with stage 2 type 1 diabetes, has been approved by the US Food and Drug Administration (FDA). Tzield clinical trials that supported the US Food and Drug Administration approval.

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Pharma Marketing Network

MAY 3, 2023

Pharmaceutical marketing is a critical aspect of the industry, as it helps in spreading awareness about the benefits and potential side effects of different drugs. However, pharmaceutical marketing is also regulated by several agencies to ensure that patients are not exposed to false or misleading information. References: 1.

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European Pharmaceutical Review

DECEMBER 22, 2023

It has demonstrated improvements in cognition and is not associated with common side effects of currently approved treatments like weight gain. Currently under review by the US Food and Drug Administration (FDA), KarXT is expected to launch in the US in late 2024.

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European Pharmaceutical Review

JULY 5, 2022

Several lifestyle factors have been shown to increase the risk of developing stomach cancer, including alcohol consumption, smoking and consuming foods preserved by salts. There is an urgent need for more effective chemotherapy treatments with less severe toxicity and side effects.

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European Pharmaceutical Review

NOVEMBER 2, 2023

The US Food and Drug Administration ( FDA) has approved Wezlana (ustekinumab-auub) as a biosimilar to Johnson & Johnson’s Stelara (ustekinumab). Like Stelara, the most serious known side effect of Wezlana is infection. He added that the approval of Wezlana “could have a meaningful impact for patients managing their disease.”

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World of DTC Marketing

JULY 5, 2022

Pharma websites provide the prescription that can help people overcome health problems but too often, they ignore the patient’s responsibility to lose weight and exercise. While the population is more worried about COVID, they are killing themselves by overeating processed food and not getting any exercise.

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Pharmaceutical Technology

DECEMBER 7, 2022

On 29 November, the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) warned of some new and potentially serious eye-related side effects associated with Dupixent, an interleukin (IL)-4/13 inhibitor drug used in the treatment of numerous allergic indications such as atopic dermatitis, asthma and nasal polyps.

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World of DTC Marketing

JANUARY 7, 2022

Pharmacists have patients every day more concerned (and in some cases consumed) about whether their prescription was run on GoodRx instead of having any interest in learning how to take the medication and what to look for with side effects. Right now, there’s a lot of investment hype around Food Rx.

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Pharmaceutical Technology

MARCH 13, 2023

The US Food and Drug Administration (FDA) has granted approval for Acadia Pharmaceuticals ’ Daybue (trofinetide) to treat Rett syndrome in adult and paediatric patients aged two years and above. Vomiting and diarrhoea are the most common side effects observed in the trial.

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European Pharmaceutical Review

NOVEMBER 3, 2023

The Medicines and Healthcare products Regulatory Agency (MHRA) has authorised Pfizer’s Litfulo (ritlecitinib) for treatment for severe alopecia areata in patients 12 years and older. A hard capsule medicine, Litfulo is recommended to be taken daily as one 50mg oral dose. Litfulo’s active ingredient, ritlecitinib, is an enzyme inhibitor.

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European Pharmaceutical Review

OCTOBER 14, 2022

RemeGen has announced that the US Food and Drug Administration (FDA) has granted Orphan Drug Designation (ODD) for its proprietary novel fusion protein Telitacicept (RC18) for the treatment of myasthenia gravis (MG). MG is a chronic autoimmune neuromuscular disease that causes patients to be prone to fluctuating muscle weakness.

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pharmaphorum

OCTOBER 26, 2022

Psoriasis is a tricky disease to manage, as drawbacks and side effects loom with each and every type of treatment. But two new non-steroidal topicals were introduced this year — Dermavant Science’s Vtama and Arcutis Biotherapeutics’ Zoryve — and each one solves a long-time problem plaguing millions of psoriasis patients.

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Pharmaceutical Technology

JUNE 19, 2023

The drug has been designed for the selective treatment of liver cancers and for minimising the treatment’s side effects. It is being developed as an orally administrated drug to treat patients with hepatocellular carcinoma (HCC), the most common form of liver cancer.

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Pharmaceutical Technology

JUNE 1, 2023

The US Food and Drug Administration (FDA) has granted clearance to Analog Pharma and Dipharma’s abbreviated new drug application (ANDA) for 20mg nitisinone capsules. Nitisinone capsules are indicated for the treatment of adult and paediatric patients with HT-1 in combination with dietary restriction of tyrosine and phenylalanine.

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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. The 126 patients were randomly assigned in a 1:1 ratio, with 62 receiving oral difelikefalin 2mg and 63 given placebo twice daily for eight weeks. points in patients receiving difelikefalin versus 2.4

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Pharma Leaders

APRIL 19, 2023

Ardelyx has resubmitted a new drug application (NDA) for Xphozah (tenapanor) to the US Food and Drug Administration (FDA). Diarrhea was the most common side effect using Xphozah in clinical trials. This reduces the absorption of phosphate via the paracellular pathway, which is the main pathway of phosphate absorption.

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Pharmaceutical Technology

JUNE 12, 2023

A US Food and Drug Administration (FDA) Advisory Committee (AdCom) has unanimously voted in support of Eisai and Biogen’s Leqembi and its clinical benefit in patients with early Alzheimer’s disease , raising the drug’s full approval prospects. The trial reported a statistically significant reduction of clinical decline in the patients.

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European Pharmaceutical Review

JANUARY 9, 2023

The US Food and Drug Administration (FDA) has granted Leqembi (lecanemab-irmb) Accelerated Approval for Alzheimer’s. Thus, the drug is suitable for patients with mild cognitive impairment or mild dementia stage of disease. The agency’s judgement is based on trial results which showed Leqembi helped to reduce amyloid beta plaque.

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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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Pharma Leaders

JUNE 14, 2023

Eupraxia Pharmaceuticals has received Fast Track designation from the US Food and Drug Administration (FDA) for EP-104IAR to treat osteoarthritis of the knee in adult patients. It offers dual advantage of providing a longer duration of pain relief, with less systemic side effects, stated the company.

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Pharma Leaders

MAY 18, 2023

The US Food and Drug Administration (FDA) has accepted Ardelyx’s resubmitted New Drug Application (NDA) for XPHOZAH (tenapanor) to control serum phosphate in adult patients with chronic kidney disease on dialysis who have had an insufficient response or intolerance to a phosphate binder therapy.

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World of DTC Marketing

JULY 15, 2021

According to STAT News, “acting Food and Drug Administration Commissioner Janet Woodcock acknowledged on Wednesday her agency may have misstepped in the handling of its polarizing approval of a new Alzheimer’s drug.” This approval was NOT about patients; it was about the profits of a pharma company in quicksand and sinking fast.

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European Pharmaceutical Review

JANUARY 3, 2023

The US Food and Drug Administration (FDA) has given the first approval of a treatment for advanced alveolar soft part sarcoma (ASPS) to atezolizumab (Tecentriq), for adults and children two years and older with ASPS that has spread to other parts of the body or cannot be removed by surgery.

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Pharmaceutical Technology

AUGUST 12, 2022

In June this year, it was announced that the US Food and Drug Administration (FDA) had granted UK-based OxfordVR a breakthrough device designation for its gameChangeVR treatment to deliver immersive cognitive behaviour therapy (CBT) to people suffering from schizophrenia and other mental illnesses. million people in the UK and 2.7

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Pharmaceutical Technology

APRIL 11, 2023

Oracle company Cerner Enviza and John Snow Labs have collaborated with the US Food and Drug Administration (FDA) for the development of artificial intelligence (AI) tools for drug safety and real-world evidence studies. During the two-year project, the companies will assess the mental health side effects of the asthma drug, montelukast.

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Pharmaceutical Technology

APRIL 21, 2023

Entadfi, a combination of finasteride and tadalafil, is administered as an oral, once-a-day drug to provide a safe and effective treatment option for benign prostatic hyperplasia (BPH), often referred to as enlarged prostate, in men. The US Food and Drug Administration granted approval to Entadfi for the treatment of BPH in December 2021.

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European Pharmaceutical Review

DECEMBER 1, 2022

Rebyota, the first faecal microbiota product to prevent recurrence of Clostridioides difficile infection (CDI) in people 18 years and older after being given antibiotics for recurrent CDI, has been approved by the US Food and Drug Administration (FDA). Hope for patients with recurrent CDI. Further clinical study data for Rebyota.

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World of DTC Marketing

FEBRUARY 4, 2021

Food and Drug Administration (FDA) is meant to help patients and warn of potential drug side effects but a Vice report indicates something more. Misuse Federal Data to Falsely Claim COVID Vaccines Are Dangerous. He said it would take years to analyze all the data.

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Pharmaceutical Technology

NOVEMBER 3, 2022

The funding will be used for the Phase III clinical trial and potential marketing of the investigational compound, ecopipam, for treating Tourette syndrome patients. Additionally, trial subjects did not have adverse movement or metabolic side effects usually seen with antipsychotic agents.

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Pharmaceutical Technology

MAY 26, 2023

After earning multimillion dollar revenues while being an authorised preferred treatment for Covid-19, the US Food and Drug Administration (FDA) has granted a full approval to Pfizer’s oral antiviral Paxlovid (nirmatrelvir + ritonavir). However, other studies found that the relapse in symptoms occurs in patients independent of Paxlovid use.

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Legacy MEDSearch

OCTOBER 25, 2022

Food and Drug Administration (FDA) granted Breakthrough Device Designation for the Company’s EndoStim System. Our goal is to bring this new therapy to patients as quickly as possible. We look forward to working closely with the FDA to expedite the review of the EndoStim System.”. About the EndoStim System. About EndoStim.

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Pharmaceutical Technology

JUNE 16, 2023

Since some of the patients with major clinical depression do not respond sufficiently to one or more antidepressants, there is a need for new treatments, said Buntinx. Due to this, adjunctive treatments are used as part of a patient’s treatment regimen. While the drug is marketed in other countries, it is not registered in the US.

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pharmaphorum

AUGUST 11, 2022

The system did not only spend money and resources trying to address issues caused by those treatments, but patients also wasted time looking for answers; precious time that could have been spent receiving proper and effective treatment. billion in the United States alone.

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Pharmaceutical Technology

OCTOBER 13, 2022

The news of the offer came just weeks after Myovant and its partner, Pfizer , received the US Food and Drug Administration's (FDA) expanded approval of Myfembree (estradiol + norethindrone acetate + relugolix) for the management of moderate to severe pain associated with endometriosis.

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European Pharmaceutical Review

NOVEMBER 9, 2023

Positively, Brager shared that in clinical trials , the company’s lead clinical candidate has demonstrated ability to cross the blood-brain barrier and to “not cause serious side effects common with traditional immunosuppressive therapies that treat inflammation.”

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Pharmaceutical Technology

APRIL 24, 2023

The British institute that oversees a therapy’s cost-effectiveness opted for the recommendation based on clinical data from the Phase II CAPTIVATE and the Phase III GLOW studies. The combination therapy also caused fewer side effects, with heart problems and hypertension as the most common ones, based on the final draft guidance.

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pharmaphorum

OCTOBER 13, 2022

In the last decade, there has also been rapid development and interest in CRISPR/Cas9 technology and other gene-editing tools that could offer transformative avenues to deliver gene therapies for patients and families affected by devastating diseases such as sickle cell disease and thalassemia. Bringing in the patient perspective.

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