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.” Today Twitter is filled with MS patients reporting nasty side effects from Biogen’s drug.

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Food and Drug Administration FDA Side effects Ethics 276

European Pharmaceutical Review

JUNE 27, 2025

Instead of inhibiting CDK2, which can lead to side effects, the drug removes CDK2 from cells. MGDs offer potential for safer, more precise and effective treatments for cancers that rely on CDK2 activity, Gilead shared. Gilead Sciences, Inc. The small molecule treatment provides a new mechanism of action. billion by 2033.

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Food and Drug Administration Side effects Food Leads 52

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). Telitacicept is a proprietary novel fusion protein from RemeGen to treat autoimmune diseases.

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Food and Drug Administration Side effects Food FDA 124

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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Food and Drug Administration FDA Side effects Food 98

European Pharmaceutical Review

OCTOBER 10, 2022

The US Food and Drug Administration (FDA) has approved GlaxoSmithKline Biologicals’ Boostrix vaccine for use in pregnant woman in their third trimester, to prevent against whooping cough (pertussis) in infants up to two months of age. Researchers gave 340 volunteers a non-US Boostrix formulation and 340 a saline placebo.

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FDA Food and Drug Administration Side effects Food 105

Pharma Leaders

MARCH 4, 2025

IEMs are a group of rare genetic disorders that disrupt the body’s ability to metabolize food, often due to enzyme deficiencies. For instance, phenylketonuria (PKU), a common IEM affecting one in 25,000 newborns, requires strict avoidance of high-protein foods.

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European Pharmaceutical Review

NOVEMBER 4, 2022

A new computer model has successfully simulated a clinical trial evaluating the efficacy of aducanumab and donanemab for Alzheimer’s disease (AD), establishing a gradual increase in dosage up to the maximum dose helps to minimise cognitive decline and limit side effects. .

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Food and Drug Administration Side effects Food Patients 105

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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Pharmaceutical Technology

MAY 16, 2023

The US Food and Drug Administration (FDA) has approved expanded labelling for Cumberland Pharmaceuticals’ Caldolor therapy to include use in infants. Caldolar is an intravenously provided formulation of ibuprofen which may now be administered to treat pain and fever in patients from three months to six months of age.

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Food and Drug Administration FDA Side effects Safety 98

pharmaphorum

OCTOBER 26, 2022

Psoriasis is a tricky disease to manage, as drawbacks and side effects loom with each and every type of treatment. Food and Drug Administration approved Vtama (tapinarof) cream, an aryl hydrocarbon receptor agonist and the first FDA-approved steroid-free topical medication in its class. Side effects, front and centre.

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Pharmaceutical Technology

NOVEMBER 23, 2022

The US Food and Drug Administration (FDA) has granted approval for CSL Behring’s adeno-associated virus vector-based gene therapy, Hemgenix (etranacogene dezaparvovec), to treat haemophilia B (congenital Factor IX deficiency) in adult patients.

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Food and Drug Administration FDA Side effects Food 105

pharmaphorum

DECEMBER 4, 2022

The device has been tested in animals so far, and last year Neuralink unveiled a pig called Gertrude which had a chip implanted that allowed neural activity in her snout to be transmitted and recorded as she rooted for food. Take action! Retweet this thread and tell @elonmusk to release the tapes! link] (12/12).

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pharmaphorum

OCTOBER 19, 2022

PKU is a rare genetic disease that manifests at birth and is marked by an inability to break down phenylalanine (phe), an amino acid that is commonly found in many foods. Left untreated, high levels of the amino acid become toxic to the brain and may lead to serious neurological and neuropsychological issues.

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European Pharmaceutical Review

NOVEMBER 3, 2023

The most common side effects of Litfulo are headache, diarrhoea, dizziness, acne, rash, inflammation of the hair follicles that may be itchy or painful and an increase in an enzyme called creatine phosphokinase, shown by blood test.

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Food and Drug Administration Side effects Medicine Food 104

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.

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Food and Drug Administration FDA Side effects Safety 98

European Pharmaceutical Review

FEBRUARY 9, 2023

To date, there are no US Food and Drug Administration (FDA)-approved treatments specifically targeting this disorder. Side effects seen in the trial included headache, dizziness, constipation, and increased urine output occurred with difelikefalin. The baseline mean score on the Worst Itch Numeric Rating Scale was 7.6

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Food and Drug Administration FDA Side effects Medicine 97

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.

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Food and Drug Administration Pharmacology Side effects Physicians 141

European Pharmaceutical Review

JANUARY 9, 2023

The US Food and Drug Administration (FDA) has granted Leqembi (lecanemab-irmb) Accelerated Approval for Alzheimer’s. In the trial, the most common side effects of Leqembi were infusion-related reactions, headache and amyloid-related imaging abnormalities (ARIA).

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Food and Drug Administration FDA Side effects Food 96

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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Food and Drug Administration Side effects Safety Food 98

European Pharmaceutical Review

DECEMBER 18, 2023

Treatment-related side effects included nausea and headache but were generally mild. “As Classified as a Schedule I drug—defined as having no accepted medical use and a high potential for abuse— psilocybin is currently not approved by the US Food and Drug Administration (FDA) for clinical use.

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European Pharmaceutical Review

OCTOBER 18, 2024

This new treatment could decrease long-term side effects including second cancers later in life and heart and lung conditions, according to the researchers. The goal of this study was to improve the cure rate while also minimising side effects and long-term toxicities—and that’s what makes this an unprecedented clinical trial.”

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Side effects Food and Drug Administration Food Patients 59

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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Side effects Food and Drug Administration Safety Physicians 64

European Pharmaceutical Review

OCTOBER 17, 2024

Additionally, EURneffy could alleviate the risk of accidental needle-related side effects (such as injection into the blood vessel and hand) 3 and it has the attributes of being smaller in size, has better temperature sensitivity, and is less complex to use compared to needle-based injectors.

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Food and Drug Administration Medicine Food Side effects 121

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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Legacy MEDSearch

OCTOBER 25, 2022

Food and Drug Administration (FDA) granted Breakthrough Device Designation for the Company’s EndoStim System. EndoStim therapy is designed to restore normal esophageal function and preserve normal anatomy to avoid the typical gastrointestinal side effects of traditional anti-reflux surgery.

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Food and Drug Administration FDA Side effects Recruitment 98

pharmaphorum

AUGUST 11, 2022

Identifying those variations helps to target medication changes that can be safer and more effective. Some people are hyper-metabolisers, meaning a drug may move too fast through their system and not deliver the intended therapeutic effect; while others may metabolise a drug too slowly, triggering an adverse side effect or overdose.

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Pharmaceutical Technology

AUGUST 17, 2008

Some of that funding is going towards other efforts, including food safety. ASL: There has been a lot of debate around black box labelling (to warn drugs could have serious side effects) recently, including specific rules concerning epilepsy drugs. NB: What will the $275m boost proposed by the administration do to aid the FDA?

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Food and Drug Administration Food FDA Safety 40

European Pharmaceutical Review

OCTOBER 19, 2023

we must prove the effectiveness of radiopharmaceuticals through clinical trials… This has been demonstrated recently with PLUVICTO… the first US Food and Drug Administration (FDA)-approved targeted radioligand therapy for eligible patients with prostate cancer” At this moment, there is no single treatment for cancer today.

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Food and Drug Administration Side effects Manufacturing Doctors 105

Pharmaceutical Technology

JANUARY 24, 2023

The US Food and Drug Administration (FDA) has granted clearance for Neurogene’s investigational new drug (IND) application for NGN-401 to treat Rett syndrome. We believe the preclinical profile for NGN-401 is highly compelling, with the strongest results generated to date across multiple animal models.

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Pharmaceutical Technology

JULY 20, 2022

On 6 July, in an effort to accelerate access, the US Food and Drug Administration (FDA) allowed pharmacists to also begin prescribing the drug to eligible individuals with Covid-19. A key factor of Pfizer’s Covid-19 antiviral Paxlovid efficacy has been early intervention, but getting it in time has proven to be a challenge.

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Food and Drug Administration Physicians Prescription Medical 111

Celeritas

MARCH 3, 2023

Because drugs aren’t personalized, they often have irregular side effects. link] Yellow Biotech: production of food Biotech is applied to the animal feed industry in terms of output, nutritional value, preservation, early maturation, etc. These threaten our marine ecology as well as our future source of food.

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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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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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Food and Drug Administration FDA Side effects Food 52

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. Some of the most common side effects of nitisinone include low platelet count, elevated tyrosine levels, eye pain, white or cloudy cornea from scarring, and pink eye.

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Food and Drug Administration FDA Side effects Pharmaceutical products 52

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. It has a new action mechanism and acts locally in the gut to inhibit the sodium hydrogen exchanger 3 (NHE3).

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Food and Drug Administration FDA Side effects Food 52

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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Safety Food and Drug Administration FDA Side effects 59

Pharmaceutical Technology

JULY 28, 2022

One potential benefit of cobitolimod’s unique route of administration is that local administration via rectal enema has the potential to limit systemic absorption and the immune-related side effects that plague some marketed agents. Abivax is developing obefazimod, another agent with a first-in-class mechanism.

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