Pharmaceutical Technology

AUGUST 5, 2022

In addition, for doctors who do use Lucentis, there will be added pressure from payers to switch to Cimerli with its direct interchangeability with Lucentis approved. The post FDA approves Coherus’ Cimerli for DME, with year-long interchangeability exclusivity appeared first on Pharmaceutical Technology.

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STAT News

JULY 15, 2022

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.

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FDA Approval Drugs Doctor Doctors 105

XTalks

SEPTEMBER 6, 2022

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. If the suspected cause of a gastric ulcer is due to an NSAID, another type of pain reliever may be recommended, such as paracetamol.

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Fierce Pharma

AUGUST 30, 2023

Even without an FDA approval, Roche’s cancer drug Avastin is widely used by doctors to treat certain eye diseases. Even without an FDA approval, Roche’s cancer drug Avastin is widely used by doctors to treat certain eye diseases.

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FDA Approval Doctor Doctors Manufacturing 110

Pharmaceutical Technology

OCTOBER 1, 2022

Indicated for use as a monotherapy or along with currently approved therapies, Relyvrio can be administered orally by mixing a packet in eight ounces of water. The FDA approval is based on findings from the multicentre Phase II CENTAUR clinical trial that enrolled 137 ALS patients.

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FDA Approval Pharmacy Doctor Doctors 244

NPR Health - Shots

APRIL 8, 2023

Some doctors prescribe sublingual immunotherapy, known as SLIT, a serum taken as drops under the tongue. Patients like it, but it is not FDA-approved, so insurance usually doesn't cover it. Image credit: Drew Angerer/Getty Images)

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Allergies FDA Approval Doctor Doctors 115

XTalks

NOVEMBER 4, 2021

We are proud to offer Vuity as a first-of-its-kind once-daily eye drop that we believe will change the way people and their eye doctors approach presbyopia. The FDA approval of Vuity exemplifies our continued pursuit of innovative new treatments that push the boundaries of what’s possible in eye care.”.

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FDA Approval Drug Delivery Systems Trials Drug Delivery 98

World of DTC Marketing

JUNE 2, 2021

SUMMARY: Doctors said they were dissatisfied were marketing emails (46%), telephone sales calls with sales reps (42%), and both webinars and websites (each at 39%) from pharma companies, according to Indegene. One of our tests, one of the most read emails, had a subject line of “new label information for prescribing just FDA approved.”

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Doctor Doctors Sales Marketing 180

World of DTC Marketing

JUNE 6, 2021

The headlines read “FDA approves obesity drug that helped people cut weight 15%” But buyer beware. My guess is Norvo will heavily discount the product via coupons or cards, but ultimately patients working with their doctor will determine if it’s successful. appeared first on World of DTC Marketing.com.

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pharmaphorum

JANUARY 21, 2021

Entresto (sacubitril+valsartan) was FDA-approved in patients with reduced ejection fraction five years ago. Meanwhile, AstraZeneca’s Farxiga (dapagliflozin), originally a diabetes drug, was approved in the US last year in heart failure with reduced ejection fraction. .

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FDA Approval Drugs Trials Doctor 72

World of DTC Marketing

JANUARY 1, 2022

1ne: The value proposition of prescription drugs still outweighs potential side effects – Wegovy’s demand quickly exceeded supply after the FDA approved once-weekly semaglutide injections. Here are things I believe are more realistic.

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Marketing Doctor Doctors FDA Approval 244

World of DTC Marketing

FEBRUARY 2, 2022

While some doctors have been eager to start prescribing the newly approved drug, others had criticized the FDA for clearing the drug before studies proved it works. ” A physician on STAT News wrote, “the consequences of FDA approval are as disturbing as they are vast.

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FDA Approval Drugs Doctor Doctors 239

Fierce Pharma

JULY 13, 2023

After a full FDA approval 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.

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FDA Approval Doctor Doctors Drugs 78

STAT News

DECEMBER 30, 2022

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. Read the rest…

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FDA Approval Doctor Doctors Drugs 98

Fierce Pharma

MAY 29, 2024

Stimulants are typically the go-to option for doctors prescribing treatments for attention-deficit hyperactivity disorder (ADHD). Tris Pharma has won FDA approval for Onyda XR (clonidine hydrochloride).

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FDA Approval Doctor Doctors 76

Fierce Pharma

JULY 17, 2023

Apellis Pharmaceuticals' Syfovre, after achieving the first FDA approval for advanced eye disease geographic atrophy, has been associated with rare but severe side effects, according to the America | The American Society of Retinal Specialists sent out a note to doctors on Saturday warning of eye inflammation cases in patients who took Syfovre, (..)

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FDA Approval Doctor Doctors 86

pharmaphorum

NOVEMBER 24, 2020

The disease is also difficult to diagnose and often takes around six years before doctors correctly identify it. Alnylam’s Givlaari, FDA-approved a year ago for acute hepatic porphyria, costs $575,000 per year at full price in the US, although after discounts the figure is more likely to be in the region of $442,000 per year.

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Pharmaceutical Technology

MARCH 24, 2023

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 addition, two more Humira biosimilars are currently under FDA review and both are anticipated to launch in 2023.

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XTalks

OCTOBER 4, 2022

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?

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XTalks

NOVEMBER 15, 2024

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.

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XTalks

JUNE 17, 2024

Numerous doctors offer minimally invasive treatments aimed at reducing the visibility of frown lines. Efficacy and Safety of Letybo FDA approval was granted based on encouraging outcomes from three completed Phase III trials, encompassing over 1,000 participants across the US and Europe.

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The Pharma Data

JANUARY 17, 2021

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. It was developed with Genmab.

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FDA Approval Drug Delivery Development Doctor 52

World of DTC Marketing

JUNE 17, 2021

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 FDA approved the product.

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pharmaphorum

AUGUST 13, 2020

There have been no signs of liver toxicity in the 80 patients treated so far, but the FDA is warning doctors to monitor renal function as this issue has been observed in patients taking antisense oligonucleotides. The post NS Pharma takes on Sarepta as FDA approves DMD drug appeared first on.

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FDA Approval Drugs Gene Trials 52

pharmaphorum

APRIL 27, 2021

Cognoa has filed for FDA approval of a digital device that could be used to diagnose autism, which the company argues could redefine care standards. . Autism can be difficult to diagnose as there are no medical markers to show its presence – instead doctors look at the child’s developmental history and behaviour to make a diagnosis.

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Pharmacy Checkers

FEBRUARY 14, 2020

I have reported this to the FDA and will be seeing my doctor this week. Apparently, the FDA had approved Budeprion XL 300mg after undergoing no actual testing. Of our most merciful health insurance companies, few are willing to cough up the cost of expensive brand meds when there’s an FDA-approved generic on the market.

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Branding FDA Approval Pharmacy Bioequivalency 62

XTalks

OCTOBER 28, 2024

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.

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Insulin FDA Approval Marketing Doctor 105

World of DTC Marketing

JUNE 23, 2021

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. Biogen’s Aduhelm won FDA approval after discovering that some patients on higher dosages had displayed improvement of.39

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Drugs FDA Approval Doctor Doctors 218

The Pharma Data

AUGUST 16, 2020

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.

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FDA Approval Antibody Clinical Trials Clinical Trials 52

XTalks

OCTOBER 7, 2022

The approval of omidenepag isopropyl ophthalmic solution 0.002% provides doctors with another safe and effective option to use when treating patients with these sight-threatening conditions,” said Jason Bacharach, MD, and Medical and Research Director at North Bay Eye Associates, Inc., in the press release.

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pharmaphorum

OCTOBER 21, 2021

Many are still predicting multibillion-dollar sales for the drug, albeit with a longer runway, despite reservations about its clinical efficacy among doctors and payers. Analysts meanwhile have suggested that Aduhelm may start to pick up momentum if that review is positive.

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pharmaphorum

MARCH 25, 2022

Tech giant Google has filed for FDA approval to use its Fitbit wearable to help detect atrial fibrillation (AFib), a common heart abnormality that raises the risk of heart attack, stroke and sudden death. Google – which acquired Fitbit for $2.1

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FDA Approval Doctor Doctors Regulation 122

The Pharma Data

MAY 19, 2023

ABBOTT RECEIVES FDA APPROVAL FOR TACTIFLEX™ ABLATION CATHETER FOR TREATMENT OF ABNORMAL HEART RHYTHM Abbott (NYSE: ABT) today announced that the U.S. 6 “Abbott is leading the way in helping doctors manage common arrhythmias with the most holistic portfolio for this condition in the world,” said Christopher Piorkowski, M.D.,

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FDA Approval Doctor Doctors Branding 52

The Pharma Data

AUGUST 17, 2021

If your doctor decides to give your child any insulin products, he or she may give you special instructions. Do not change the type of insulin you take or your dose, unless your doctor tells you to. If you are at risk of having severely low blood sugar, your doctor may prescribe a glucagon emergency kit. Before using.

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Insulin FDA Approval Doctor Doctors 52

FDA Law Blog

AUGUST 21, 2023

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. That requirement would only be fulfilled if FDA agreed to such a change. But we digress. And indeed, after Pliva v.

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FDA Approval Production Drugs Generic Drugs 40

The Pharma Data

JULY 29, 2021

BOTOX ® was first approved by the FDA in 1989 for two rare eye muscle disorders – blepharospasm and strabismus in adults. Tell your doctor if you have any breathing-related problems. Tell your doctor if you have any breathing-related problems. About BOTOX ®. Cornea problems have been reported. versus 0.4%, respectively).

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Botox FDA Approval Doctor Doctors 52

The Pharma Data

DECEMBER 12, 2020

While survival rates have improved as doctors have learned which treatments work, hospital shortages raise the possibility of increasing mortality rates once again if patients don’t get the level of care they need.

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