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Even before the Covid pandemic, a 2018 paper reported that new genetic tests, many of them for increasingly rare conditions, were being released at the rate of 10 a day. You can now avail yourself of noninvasive diagnostics that claim to screen for rare birth defects, cancer-associated mutations, and even Alzheimer’s.
Food and Drug Administration (FDA) just approved Zepbound (tirzepatide) for chronic weight management. The injectable medication is a new version of Eli Lilly’s Mounjaro, which is approved by the FDA to control blood sugar in people with Type 2 diabetes. Zepbound, on the other hand, has been FDA-approved for weight loss.
The HDAC inhibitor was given an accelerated approval by the FDA as a second-line PTCL therapy on the strength of overall response data, but a phase 3 study comparing Istodax to first-line chemotherapy showed no improvement on progression-free survival (PFS).
GlaxoSmithKline’s Benlysta has been on the market for almost a decade, but it still has some tricks up its sleeve – it’s just become the first and only FDA-approved treatment for lupus nephritis. AstraZeneca wasn’t so fortunate with its anifrolumab candidate, which flunked a pivotal trial in SLE in 2018, but still thinks it has potential.
Sanofi’s hopes of a speedy approval of first-in-class C1s inhibitor sutimlimab in rare disorder cold agglutinin disease (CAD) were dashed by the FDA, but new phase 3 data keep the drugmaker on track for a resubmission before year-end. At the moment CAD is managed using off-label therapies, including rituximab and corticosteroid drugs.
From 2015 to 2018, 13.2% Since Prozac (fluoxetine) was approved by the FDA in 1987, selective serotonin reuptake inhibitors (SSRIs) have been the most commonly prescribed antidepressants on the market. This is called off-label prescribing , and SSRIs rank among the top use cases for off-label use.
JAK inhibitor Xeljanz is one of Pfizer’s top-selling drugs, despite a ‘black box’ warning for blood clots and cancers added to its label in 2019. Now, a study designed to prove its safety has achieved the opposite. Xeljanz isn’t the only drug in the class to be affected by toxicity concerns of course.
After a firm submits a 510(k) to FDA, FDA will request still more information after a first-pass review. According to the 2 nd Quarter FY2023 MDUFA V Performance Report , FDA issued a request for additional information (AI request) on the first FDA review cycle for 63% to 68% of 510(k)s submitted in FY2018 to FY2022.
AstraZeneca has moved a step closer to bringing a first-in-class drug to market in the US that can be used to reduce severe asthma attacks, after an FDA advisory committee voted in favour of approval. AZ is developing PT027 with UK partner Avillion under the terms of an agreement first signed in 2018.
An FDA advisory committee 12 to 1 in favour of approving Entresto (sacubitril/valsartan) for heart failure with preserved ejection fraction (HFpEF), which accounts for around half of all heart failure cases but proves highly resistant to drug treatment. The post Entresto set for big sales hike after FDA panel endorsement appeared first on.
The FDA has started a priority review of AstraZeneca and Amgen’s severe asthma antibody tezepelumab, setting a date for a decision in the first quarter of 2022. Tezepelumab was awarded a breakthrough designation for non-eosinophilic asthma by the FDA in 2018. Results from that programme are due in 2023.
Apellis Pharma has secured FDA approval for its complement C3 inhibitor Empaveli as a treatment for paroxysmal nocturnal hemoglobinuria (PNH) – with a label that will allow it to challenge Alexion’s established therapies directly. . The post Apellis set to take on Alexion as FDA clears PNH drug Empaveli appeared first on.
Combination therapies involving Roche and AbbVie’s cancer drug Venclexta have been formally approved by the FDA in acute myeloid leukaemia, following supportive data from late-stage studies. The combination therapies had previously been marketed following accelerated approval in November 2018 on the basis of early stage results.
Roivant group company Dermavant has made the transition to a commercial-stage company after getting FDA approval for Vtama, a drug for psoriasis that it claims could be a game-changer in the treatment of the skin disorder. The post Dermavant claims its first approval as FDA clears psoriasis drug appeared first on.
The FDA has approved GlaxoSmithKline’s Jemperli (dostarlimab) immunotherapy, a drug acquired through its $5.1 While some argued that GSK overpaid for Tesaro in 2018, at least the deal is bringing badly needed new drugs to market for the under-pressure UK pharma and its highly-paid research chief Hal Barron.
Keytruda (pembrolizumab) was given an accelerated approval in 2018 as a second-line therapy for PD-L1-positive cervical cancer, but the new survival data – from the phase 3 KEYNOTE-826 trial – could extend the use of the drug.
Keytruda has struggled to make an impact in prostate cancer, and the disease does not feature on the drug’s very long list of approved indications, despite considerable clinical testing on Merck’s part, or indeed on the label’ of other drugs in the PD-1/PD-L1 inhibitor class like Bristol-Myers Squibb’s Opdivo (nivolumab).
Sanofi has won FDA approval for its sutimlimab for cold agglutinin disease (CAD) at the second time of asking, becoming the first approved therapy for the rare blood disorder in the US. The post Sanofi claims FDA okay for drug to treat rare blood disorder CAD appeared first on.
Dystrophic epidermolysis bullosa is caused by a gene mutation, and the recent FDA approval of the corrective gene therapy VYJUVEK represents the first specific treatment to become available. The FDA approval of VYJUVEK – also known as beremagene geperpavec or B-VEC – provides the first novel topical gene therapy.
While the prevalence was 1 in 150 children in 2000, it reached the rate of 1 in 44 in 2018, in the US, according to the Centers for Disease Control and Prevention. Off-label medication options. The rate at which children are being identified with autism spectrum disorder (ASD) has tripled in the past two decades.
The recent FDA approval of Fennec Pharmaceuticals’ drug PEDMARK (sodium thiosulfate injection) marks a significant advance for cancer treatment-associated hearing loss therapies, amidst a bid to improve quality of life for cancer patients. In 2018, the FDA had granted Pedmark a breakthrough orphan drug designation.
In fact, a 2018 study found that, on average, Americans pay more than two-and-a-half times as much for prescription drugs as citizens of 32 other countries involved in the study. We have a regulator called Health Canada, similar to the Food and Drug Administration (FDA), which works to ensure the safety of our drugs,” Tadrous says.
A study from 2018 confirmed its antihistamine effect in dogs. She also explains that “Zyrtec’s use for dogs is ‘ off-label.'” Check the drug’s packaging and label carefully before giving it to your pet. Standard Zyrtec, with no decongestants, can be given to dogs. How quickly does Zyrtec work in dogs?
In addition, the FDAlabel for the nighttime forms of Mucinex containing acetaminophen recommends avoiding three or more drinks per day. In addition, the FDA advises against mixing alcohol with OTC medicines containing decongestants like pseudoephedrine or phenylephrine. appeared first on The Checkup.
The development of novel radiotherapeutics ushered in a new era in targeted treatment 1 for cancer, with two separate radiotherapeutic approvals in Europe and the US, in 2018 and 2022. He also oversaw the development of Azedra a targeted radiotherapeutic recently approved by the US FDA for the treatment of rare tumors of the adrenal gland.
The Food & Drug Administration (FDA) has approved Rinvoq to treat: Atopic dermatitis Rheumatoid arthritis Psoriatic arthritis Ulcerative colitis Crohn’s disease Ankylosing spondylitis Non-radiographic axial spondyloarthritis This article will unpack the benefits, dosage, side effects, and risks of Rinvoq for atopic dermatitis.
However, turnover fell back to $148 million in 2021, mainly as a result of strong competition from AstraZeneca and Merck & Co’s class-leading Lynparza (olaparib) – which has a much broader product label – as well as GSK’s Zejula (niraparib). With finances tight, Clovis has deferred a $1.9
Roche’s closely-watched combination of two checkpoint inhibitors – TIGIT-targeting tiragolumab and PD-L1 drug Tecentriq – has claimed breakthrough status from the FDA. Roche’s drug is already FDA-approved as a monotherapy and in combination with Avastin (bevacizumab) and chemotherapy for previously-untreated NSCLC with high PD-L1 expression.
Food and Drug Administration (FDA) for relief of mild, intermittent asthma symptoms, like wheezing, cough, shortness of breath, and chest tightness. Primatene Mist was actually taken off the market in 2011 due to CFC use and not reintroduced until 2018 in the HFA form. OTC inhalers are approved by the U.S.
Keep a regular schedule : Taking ibuprofen as directed by the label or a healthcare provider can help ensure the drug is taken effectively and safely. Read labels on nonprescription products: Check the labels of OTC cold and pain medications. Many products contain ibuprofen and other NSAIDs as added ingredients.
Novartis has been steadily investing in radiopharmaceuticals over the last few years, and one of those deals has just paid off with an FDA approval for Pluvicto, the first targeted radioligand therapy for prostate cancer. After a median follow-up of 20.9 months, patients on Pluvicto had radiographic progression-free survival (PFS) of 8.7
Gaulkin & Riëtte van Laack — Chocolate-lovers and hopeless romantics rejoice: FDA has announced that it does not intend to object to the use of certain qualified health claims regarding the relationship between the consumption of cocoa flavanols in high flavanol cocoa powder and a reduced risk of cardiovascular disease. By Sophia R.
A 2018 meta-review of multiple studies involving CoQ10 supplementation found that CoQ10 significantly decreased systolic blood pressure–that’s the top number on a blood pressure reading–in 17 randomized controlled trials. Read the labels. CoQ10 Coenzyme Q10 , or CoQ10, is often heralded for its antioxidant properties.
GSK has had another setback in its oncology business, after the FDA asked it to restrict use of its PARP inhibitor Zejula in ovarian, fallopian tube, or primary peritoneal cancer to patients with a specific mutation. That was due last Friday, but cancelled when GSK opted to withdraw the approval. GSK acquired Zejula as part of its $5.1
UCLA Health (2018) Mobic label , U.S. Some of the most commonly reported side effects of meloxicam are: Diarrhea or constipation Upper respiratory tract infections Heartburn Flu-like symptoms Drowsiness According to the U.S.
Acadia has indicated previously that most patients who completed the LAVENDER trial have entered an open-label extension, which backs up the idea that the side effects are manageable. At 12 weeks, trofinetide-treated patients had a 5.1-point point reduction in the Rett Syndrome Behaviour Questionnaire (RSBQ) scale, compared to a 1.7-point
ECAs are being used to support the primary approval, label expansion of their assets and even go/no-go decisions for trials. The industry has looked to regulators for guidance, and the Food and Drug Administration (FDA) has been quick to respond. Myth 2: Implementing an ECA requires too much money, time and resource.
Gabapentin is a generic medication approved by the Food and Drug Administration (FDA) to treat postherpetic neuralgia (nerve pain after shingles), epilepsy, other seizure disorders, and restless leg syndrome. Off-label use is when a drug is used for a purpose other than what it is approved for.
Red Dye 40 is among the most commonly used artificial food dyes in the United States, and you might see it labeled under a different name on the products you consume. Regardless of what manufacturers label it as, there have been ties to specific negative side effects when ingested too frequently. 40 Aluminum Lake, and FD&C Red No.
The court case stems from October 2018, when AstraZeneca began litigation against Mylan and subsequently against 3M Company (3M) asserting infringement of various US patents covering Symbicort. Symbicort was first FDA-approved in 2006 as a treatment for asthma, followed by an extension to its label covering COPD in 2009.
For example, results from a 2018 study demonstrated “a strong inverse association between metformin and liver cancer,” and a systematic review and meta-analysis from 2016 found a significant improvement in survival rates for diabetic liver cancer patients. The daily dosage shouldn’t exceed 2550 mg.
Levothyroxine (a thyroid hormone) is FDA approved to treat hypothyroidism , a condition in which the body produces less thyroid hormone than your body needs. It’s FDA approved to treat attention-deficit/hyperactivity disorder (ADHD) symptoms, including inattention, hyperactivity, and impulsivity. Approximately 1.2%
Food and Drug Administration (FDA) to treat symptoms of ADHD, as well as narcolepsy. Ideally, that place will be dry and at room temperature, which means 68° to 77°F, according to the FDAlabel. Strattera (atomoxetine) was the first non-stimulant treatment the FDA approved for ADHD treatment.
It’s FDA approved for the treatment of ADHD and narcolepsy, but it’s sometimes prescribed off-label as a weight loss drug. people taking Adderall for narcolepsy or off-label uses). The effects of Adderall on the body No two people taking Adderall will have the same response to the drug.
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