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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pharmaphorum

NOVEMBER 12, 2021

Researchers in the US have developed an artificial intelligence-based tool that is able to predict COVID-19 symptoms and suggest which FDA-approved drugs might be used to treat patients. The post AI tool may help doctors select best drugs for COVID patients appeared first on.

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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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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 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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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 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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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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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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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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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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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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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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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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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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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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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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The Pharma Data

MAY 17, 2023

ABBOTT RECEIVES FDA APPROVAL FOR ITS SPINAL CORD STIMULATION SYSTEMS TO TREAT CHRONIC BACK PAIN IN PEOPLE WHO HAVE LIMITED SURGICAL OPTIONS Abbott (NYSE: ABT) announced today that the U.S. More than 50 million people in the U.S. suffer from chronic pain. 5 According to the U.S.

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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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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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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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The Pharma Data

JANUARY 20, 2021

FDA Approves Verquvo (vericiguat) for Heart Failure with Reduced Ejection Fraction. The approval of Verquvo provides doctors, health care professionals, and patients with a welcome new option to current available therapies.”. Related Articles: Verquvo (vericiguat) FDA Approval History. KENILWORTH, N.J.–(BUSINESS

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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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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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The Pharma Data

JANUARY 15, 2021

Food and Drug Administration (FDA) approval of Darzalex Faspro ® (daratumumab and hyaluronidase-fihj), a subcutaneous formulation of daratumumab, in combination with bortezomib, cyclophosphamide and dexamethasone (D-VCd) for the treatment of adult patients with newly diagnosed light chain (AL) amyloidosis.[1] Haematologica.

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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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Scienmag

NOVEMBER 8, 2020

Rutgers study also finds doctors continue to prescribe antipsychotic medications without the recommended psychiatric consultation for non FDA-approved conditions The use of antipsychotics in young children is declining but doctors continue to prescribe these medications off-label for conditions not approved by the Food and Drug Administration and without (..)

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The Pharma Data

SEPTEMBER 1, 2021

The FDA approval of INVEGA HAFYERA™ is based on the results of a 12-month, randomized, double-blind, non-inferiority Phase 3 global study that enrolled 702 adults (ages 18-70) living with schizophrenia from 20 countries. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

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The Pharma Data

NOVEMBER 18, 2020

Doctors say this reflects India’s younger and leaner population. Nearly 131,000 coronavirus patients have died in India, according to the Hopkins tally, but when measured as a proportion of the population, the country has had far fewer deaths than many others.

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The Pharma Data

DECEMBER 18, 2020

FDA Approves Orgovyx (relugolix) as the First Oral Gonadotropin-Releasing Hormone (GnRH) Receptor Antagonist for Advanced Prostate Cancer. Food and Drug Administration (FDA) has approved Orgovyx (relugolix) for the treatment of adult patients with advanced prostate cancer. Orgovyx (relugolix) FDA Approval History.

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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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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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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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XTalks

MAY 26, 2023

Krystal Biotech’s Vyjuvek has been awarded US Food and Drug Administration (FDA) approval to make it the first topical gene therapy for the treatment of wounds in patients with the rare, often debilitating skin disease dystrophic epidermolysis bullosa (DEB).

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pharmaphorum

JUNE 14, 2022

Eli Lilly and Incyte’s Olumiant has secured the first FDA approval 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.

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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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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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