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Food and DrugAdministration approved Eli Lilly’s novel treatment for diabetes. The drug led to impressive blood sugar and body weight drops in clinical trials. Will patients, who are obese and don’t have Type 2 diabetes, ask for the drug for weight loss, and will patients understand the risks?
Immunotherapy drugs like teclistamab can result in potentially fatal sideeffects, including CRS and immune cell-associated neurotoxicity syndrome (ICANS). The drug tocilizumab for example, has been used historically to treat CRS from immunotherapies. We are going with full steam into an era of immunotherapy.”
Biogen will partner with Roche on the development, and potential sale of a promising cancer drug the Swiss pharma is advancing for several types of lymphoma, announcing Tuesday it’s exercised an option to share rights to the treatment. Food and DrugAdministration on Biogen Inc.’s
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.
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 DrugAdministration (FDA). Tzield clinical trials that supported the US Food and DrugAdministration approval.
a China-based pharma company has announced it has received clearance for its Investigational New Drug (IND) application from the US Food and DrugAdministration (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.
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.
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 sideeffects. .
Merck’s old drugs are under more scrutiny, and anti-vaxxers are causing problems by cherry-picking unreliable information. regulators knew about reports of suicidal behavior in men taking the anti-baldness treatment Propecia when they decided not to warn consumers of those potential risks in a 2011 update of the popular drug’s label.
To date, there are no US Food and DrugAdministration (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.
RemeGen has announced that the US Food and DrugAdministration (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.
Following her presentation on age-related disease at BioFuture 2023, Executive Vice President of Drug Development for MyMD Pharmaceuticals ® , Jenna Brager, shares with EPR why the company’s next-generation tumour necrosis factor (TNF)-alpha inhibitor has potential in inflammatory and autoimmune disorders.
The US Food and DrugAdministration (FDA) has approved expanded labelling for Cumberland Pharmaceuticals’ Caldolor therapy to include use in infants. Caldolor has already obtained FDA approval for pre-operative administration.
EndoStim , a medical device company developing and commercializing a first-in-class implantable neurostimulation treatment for drug refractory gastroesophageal reflux disease (GERD), announced that the U.S. Food and DrugAdministration (FDA) granted Breakthrough Device Designation for the Company’s EndoStim System.
When developing content for new drug labels, life sciences companies’ regulatory teams face challenges in gathering intelligence to better understand competitive factors, market dynamics, and effective approval strategies. Food and DrugAdministration (FDA) or European Medicines Agency (EMA).
The major concerns for hesitancy included worries over sideeffects and that the vaccine is too new. Also cited was a lack of trust in the government to ensure the vaccines’ safety and effectiveness. The government allowed the drugmakers to mass-produce the vaccine while still conducting clinical trials.
The US Food and DrugAdministration (FDA) has granted Leqembi (lecanemab-irmb) Accelerated Approval for Alzheimer’s. The FDA’s decision means the drug is the second of a new category of medications approved for Alzheimer’s that target the fundamental pathophysiology of the disease. Clinical trial results for Leqembi .
The US Food and DrugAdministration (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.
Data from this Phase II supported US Food and DrugAdministration (FDA) approval: a 98 percent response rate and an 83 percent complete response rate. Overall, rates of serious sideeffects of cilta-cel were similar to those reported in previous clinical trials, according to findings from the real-word study.
The US Food and DrugAdministration (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.
The US Food and DrugAdministration ( FDA) has approved Wezlana (ustekinumab-auub) as a biosimilar to Johnson & Johnson’s Stelara (ustekinumab). Like Stelara, the most serious known sideeffect of Wezlana is infection.
Last month, CARVYKTI ® (ciltacabtagene autoleucel; cilta-cel) was the first BCMA-targeted CAR-T cell therapy to be approved for second-line treatment of multiple myeloma by the US Food and DrugAdministration (FDA). CAR T-cell Therapy and its sideeffects [Internet]. National Cancer Institute. Cancer.gov.
Treatment-related sideeffects 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 DrugAdministration (FDA) for clinical use.
It has demonstrated improvements in cognition and is not associated with common sideeffects of currently approved treatments like weight gain. Currently under review by the US Food and DrugAdministration (FDA), KarXT is expected to launch in the US in late 2024.
The most common sideeffects 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.
The common, expected sideeffects were within expectations for a vaccine in this age group. In November 2021, the US Food and DrugAdministration (FDA) authorised the emergency use of COVID-19 vaccine Comirnaty ® in children aged five to 11 years.
Psoriasis is a tricky disease to manage, as drawbacks and sideeffects loom with each and every type of treatment. Food and DrugAdministration approved Vtama (tapinarof) cream, an aryl hydrocarbon receptor agonist and the first FDA-approved steroid-free topical medication in its class. First in class.
In June this year, it was announced that the US Food and DrugAdministration (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.
Oracle company Cerner Enviza and John Snow Labs have collaborated with the US Food and DrugAdministration (FDA) for the development of artificial intelligence (AI) tools for drug safety and real-world evidence studies.
The most common sideeffects related to vaccination were injection site pain, malaise, fatigue, muscle aches and headaches. The international study will continue to examine the effects of two-dose HEPLISAV-B. A two-dose version of the vaccine was approved by the US Food and DrugAdministration (FDA) in 2017.
The US Food and DrugAdministration (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 sideeffects observed in the trial.
On 29 November, the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) warned of some new and potentially serious eye-related sideeffects 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.
Emalex Biosciences has raised Series D funds worth $250m led by Bain Capital Life Sciences to progress the development of an investigational new drug for Tourette syndrome. Additionally, trial subjects did not have adverse movement or metabolic sideeffects usually seen with antipsychotic agents.
On 6 July, in an effort to accelerate access, the US Food and DrugAdministration (FDA) allowed pharmacists to also begin prescribing the drug to eligible individuals with Covid-19. The pharmacist can then review their medical history to make sure there are no concerns of drug-drug interactions with Paxlovid.
This new treatment could decrease long-term sideeffects 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 sideeffects and long-term toxicities—and that’s what makes this an unprecedented clinical trial.”
One of the aspects of radiopharmaceuticals that is often overlooked is how complicated it is to develop a new agent, in terms of the complexity of drug design to realise a therapeutic candidate and the implementation of the clinical evaluations. This is not an effective strategy.
A US Food and DrugAdministration (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 US Food and DrugAdministration (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.
Eupraxia Pharmaceuticals has received Fast Track designation from the US Food and DrugAdministration (FDA) for EP-104IAR to treat osteoarthritis of the knee in adult patients. After injected into the knee, EP-104IAR diffuses the drug slowly into the knee joint and provides therapeutic concentrations for up to six months.
The US Food and DrugAdministration (FDA) has granted clearance to Analog Pharma and Dipharma’s abbreviated new drug application (ANDA) for 20mg nitisinone capsules. They are available in 2mg, 5mg and 10 mg dosages and are the generic equivalent of Swedish Orphan Biovitrum’s Orfadin.
Ardelyx has resubmitted a new drug application (NDA) for Xphozah (tenapanor) to the US Food and DrugAdministration (FDA). Diarrhea was the most common sideeffect 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).
tumour effects. Nevertheless, chemotherapy’s disadvantages, including substantial toxicities, combined with inconvenient hospital-based intravenous (IV) administration, impede patients’ ability to stay on treatment and their quality of life. Taxane therapy is an established, highly effective cornerstone in oncology treatment.
After earning multimillion dollar revenues while being an authorised preferred treatment for Covid-19, the US Food and DrugAdministration (FDA) has granted a full approval to Pfizer’s oral antiviral Paxlovid (nirmatrelvir + ritonavir). Paxlovid’s most common sideeffect is diarrhoea.
The sale of an illegally imported supplement being marketed as a weight-gain enhancer has been associated with cases of dizziness, cognitive impairment, and sedation, according to the US Food and DrugAdministration (FDA).
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