This site uses cookies to improve your experience. To help us insure we adhere to various privacy regulations, please select your country/region of residence. If you do not select a country, we will assume you are from the United States. Select your Cookie Settings or view our Privacy Policy and Terms of Use.
Cookie Settings
Cookies and similar technologies are used on this website for proper function of the website, for tracking performance analytics and for marketing purposes. We and some of our third-party providers may use cookie data for various purposes. Please review the cookie settings below and choose your preference.
Used for the proper function of the website
Used for monitoring website traffic and interactions
Cookie Settings
Cookies and similar technologies are used on this website for proper function of the website, for tracking performance analytics and for marketing purposes. We and some of our third-party providers may use cookie data for various purposes. Please review the cookie settings below and choose your preference.
Strictly Necessary: Used for the proper function of the website
Performance/Analytics: Used for monitoring website traffic and interactions
Despite high demand for an option like Journavx, doctors fear the drug’s price could be a major hangup for insurers, potentially limiting patients’ ability to access it.
But uptake could be slow as insurers and doctors weigh the drug's safety and cost-effectiveness. Leqvio, which Novartis acquired for nearly $10 billion two years ago, arrives with high sales expectations.
The company expects initial uptake of Rezdiffra, which costs $47,400 per year, to be slow as doctors and insurers establish the protocols needed to find patients eligible for treatment.
Enhertu is the first targeted treatment cleared for breast cancers that are ‘HER2 low,’ a new classification that could change how doctors treat the disease.
SUMMARY: The media headlines promise weight loss for diabetes patients, but Norvo’s new drug is in the same class as other drugs and carries many warnings. Can diabetes patients really stay adherent to a drug for 63 weeks in which 85% of patients report GI side effects and will insurance cover the cost?
The US Food and Drug Administration (FDA) has granted approval to Amgen and AstraZeneca ’s Tezspire (tezepelumab-ekko) for self-administration using a single-use, pre-filled pen for severe asthma patients aged 12 years and above. Pharyngitis, arthralgia, and back pain are the most common adverse reactions of the antibody.
TriClip G4 System Manufacturer/developer : Abbott Medical Date of FDAapproval : April 1, 2024 Approved for : Tricuspid regurgitation (TR). Agent drug-coated balloon. The balloons outer surface is coated with the drug paclitaxel, a safe and effective measure to prevent the arteries from narrowing again.
Researchers in the US have developed an artificial intelligence-based tool that is able to predict COVID-19 symptoms and suggest which FDA-approveddrugs might be used to treat patients. The post AI tool may help doctors select best drugs for COVID patients appeared first on.
It was the weekend: his doctor wasn’t available, an emergency department provider told him he might have anal cancer, and an urgent care provider sent him home with Tylenol and no diagnosis. Andy couldn’t sleep more than a couple fitful hours a night because it felt like a hot fork was stabbing him in the butt.
The diabetic macular oedema (DME) space recently witnessed a new approval; the US Food and Drug Administration (FDA) announced the approval of Coherus’ Cimerli (ranibizumab-eqrn; FYB201), a vascular endothelial growth factor (VEGF) inhibitor therapy.
Even without an FDAapproval, Roche’s cancer drug Avastin is widely used by doctors to treat certain eye diseases. Even without an FDAapproval, Roche’s cancer drug Avastin is widely used by doctors to treat certain eye diseases.
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 Drug Administration on Biogen Inc.’s Food and Drug Administration on Biogen Inc.’s
Doctors may prescribe a proton pump inhibitor (PPI), such as omeprazole, which blocks acid-producing cells to protect the gastric ulcer from acid while it heals naturally. Rilpivirine is used to treat HIV infection, and if used concomitantly with omeprazole, it may reduce the antiviral effect and promote the development of drug resistance.
The US Food and Drug Administration (FDA) has granted approval for Amylyx Pharmaceuticals’ Relyvrio (sodium phenylbutyrate and taurursodiol) to treat adult patients with amyotrophic lateral sclerosis (ALS). The FDAapproval is based on findings from the multicentre Phase II CENTAUR clinical trial that enrolled 137 ALS patients.
1ne: The value proposition of prescription drugs still outweighs potential side effects – Wegovy’s demand quickly exceeded supply after the FDAapproved once-weekly semaglutide injections. People don’t want to lose weight through diet and exercise if they can lose it through a prescription drug.
Bayer and Merck & Co’s heart failure drug vericiguat has been approved by the FDA under the brand name Verquvo, in an increasingly competitive market. The drug can be used after hospitalisation for heart failure or in patients in need of intravenous diuretics.
Now, instead of reaching for reading glasses, AbbVie’s eyedrop formulation Vuity could offer help in correcting far-sightedness as the US Food and Drug Administration (FDA) granted approval to it late last week. With the approval, Vuity becomes the first eyedrop approved for presbyopia. Vuity is a 1.25
The Food and Drug Administration’s approval of Wegovy, Novo Nordisk’s latest obesity drug, for adolescents aged 12 years and older opens up a highly-anticipated tool in the fight against childhood obesity, but some doctors warn the sought-after medication isn’t a magic bullet.
After a full FDAapproval last week triggered Medicare coverage of Eisai and Biogen’s Leqembi, doctors are still trying to work out the logistics of testing and reimbursement. But at least two experts remain positive about the drug’s efficacy and safety profile.
SKIMMERS SUMMARY: Health experts, including those on an external advisory committee to the FDA, are skeptical that Biogen’s drug will even successfully slow the progression of Alzheimer’s after late-stage clinical trials yielded mixed results and are angry the FDAapproved the product. Medpage Today.
SKIMMERS SUMMARY: Jefferies analysts found doctors have shown strong interest in prescribing Aduhelm for about 35% of early-stage Alzheimer’s patients with mild cognitive impairment after surveying 50 U.S. One agency FDA adviser, resigning from his committee post in protest, called it “probably the worst drugapproval decision in recent U.S.
The FDA has approved Alnylam’s gene silencing drug Oxlumo, the first treatment for primary hyperoxaluria type 1 (PH1), an ultra-rare and life-threatening genetic disorder. The disease is also difficult to diagnose and often takes around six years before doctors correctly identify it.
Biosimilars are an important tool to facilitate competition, lower the price of drugs, and create savings across the board. Amgen’s (US) Amjevita (adalimumab) is the first Humira biosimilar, launched in February 2023, and seven other FDA-approved biosimilars are expected to arrive on the US market later this year.
In the lead-up to a critical meeting that will influence the approval of a new drug for amyotrophic lateral sclerosis (ALS), the US Food and Drug Administration (FDA) has detailed its plans to advance rare neurodegenerative disease research. The FDA’s action plan.
Exon-skipping drugs are used to patch the mutations and allow the gene to produce partially functional dystrophin. Viltepso can be used to treat around 8% of DMD patients and previously approved DMD drugs has not been shown to change the course of the disease.
ADC Therapeutics is looking to add a second approved antibody-drug conjugate to its portfolio after reporting strong phase 2 results with camidanlumab tesirine (cami) in relapsed/refractory Hodgkin lymphoma at the EHA annual meeting. “These results offer hope to patients and doctors who need a new option.”
You know how to protect against COVID and flu so ask your pharmacist or doctor about scheduling an RSV vaccine, too.” The approval is pivotal as it opens up the vaccine to the under-60 adult population. Because moments like these matter,” the commercial ends off saying. billion compared to Abrysvo’s $890 million.
Analysts were predicting sales of Biogen’s recently approved Alzheimer’s therapy Aduhelm may start to gather a little momentum in the third quarter, but the drug seems to be going into reverse. million in sales for the drug in the second quarter. Biogen reported $1.6
Patient organisations have been celebrating the FDAapproval yesterday of Amylyx’ amyotrophic lateral sclerosis (ALS) therapy Relyvrio, after not one but two advisory committee meetings that arrived at different conclusions about the drug. Bad news for Biohaven.
The US Food and Drug Administration (FDA) has approved Ipsen’s groundbreaking Sohonos (palovarotene) capsules for the treatment of fibrodysplasia ossificans progressive (FOP), an ultra-rare bone disease. Sohonos, the first and only approveddrug, offers hope to those battling the disease.
Guerbet, a pharmaceutical company based in France that specializes in medical imaging, obtained US Food and Drug Administration (FDA) approval for Elucirem (gadopiclenol), a new macrocyclic GBCA. Elucirem is indicated for use in adults and children aged 2 years and older, for contrast-enhanced MRI. What is Unique About Elucirem?
The direct-to-consumer TV commercials for Axonics Therapy have certainly helped the company establish its reputation in the non-drug incontinence therapy space. The Axonics R20 has received FDAapproval in January of this year. Firstly, a doctor will perform an evaluation to see whether Axonics Therapy is right for the patient.
Food and Drug Administration (FDA) approved Janssen Pharmaceuticals ’ (a Johnson and Johnson company) Darzalex Faspro for adults with newly diagnosed light chain amyloidosis. It was approved in combination with bortezomib, cyclophosphamide and dexamethasone (D-VCd). Michael Vi/Shutterstock.
Years ago, they took on the Food and Drug Administration in regards to Budeprion XL distributed by Teva Pharmaceuticals, the supposed generic equivalent to the popular antidepressant, Wellbutrin XL. Finally, I put it together that this was related to the drug because when I wouldn’t take it I would begin to feel better.
Hugel, a Korean medical aesthetics company, recently announced that it has received marketing approval from the US Food and Drug Administration (FDA) for its botulinum toxin, Letybo (letibotulinumtoxinA-wlbg), for the treatment of glabellar lines.
RSV researchers at major pharmaceutical companies are currently working to develop new RSV drugs to beat future waves of RSV infection and gain the first RSV vaccine FDAapproval. Pharmaceutical companies are pushing to develop drugs and vaccines for RSV with these populations in mind.
Insulet SmartAdjust Technology for Type 2 Diabetes: Simplified Insulin Dosing In August, the US Food and Drug Administration (FDA) approved Omnipod 5 for type 2 diabetes , marking it as the first automated insulin dosing device for this population.
Still, when doctors told her last year that the cancer was growing despite two operations, radiation therapy, and a fifth regimen of chemotherapy, the retired business-meeting facilitator decided to do something unorthodox: spend $83,000 out of pocket on an unproven experimental cancer vaccine.
Eli Lilly and Incyte’s Olumiant has secured the first FDAapproval for a systemic drug to treat alopecia areata, an autoimmune condition causing patchy hair loss that affects more than 700,000 people in the US. billion from its approved indications last year.
However, despite the work still left to be done, there are now a growing number of treatments in the pipeline and 2020 proved to be a remarkable year for orphan drugapprovals, with the US FDAapproving more orphan designated treatments than non-orphan drugs. Headway being made.
Livornese — I saw the sign…and the answer is no—FDA-approved labeling apparently is not enough under state failure-to-warn laws, according to certain courts. Brand drugs, generic drugs, and medical devices alike have all been the target of state failure-to-warn litigation; in a recent case, OTC acetaminophen is the target.
The US Food and Drug Administration (FDA) has issued warnings about the risk of abuse of amphetamine stimulants like Adderall, stating that use for “prolonged periods of time may lead to drug dependence and must be avoided.” The first generic versions of Strattera were approved in 2017 when the drug went off patent.
On September 22, 2022, it was announced in a press release that the solution was approved as Omlonti by the US Food and Drug Administration (FDA) for reducing elevated IOP in patients with primary open-angle glaucoma or ocular hypertension. Eventually, it was released in five countries beginning in February 2021.
First and only FDA-approved subcutaneous treatment option for anti-aquaporin-4 antibody positive NMOSD that can be self-administered by a person with NMOSD or a caregiver every four weeks. First and only approved therapy for NMOSD designed to target and inhibit interleukin-6 receptor activity, using novel recycling antibody technology.
We organize all of the trending information in your field so you don't have to. Join 21,000+ users and stay up to date on the latest articles your peers are reading.
You know about us, now we want to get to know you!
Let's personalize your content
Let's get even more personalized
We recognize your account from another site in our network, please click 'Send Email' below to continue with verifying your account and setting a password.
Let's personalize your content