pharmaphorum

NOVEMBER 26, 2020

Y-mAbs Therapeutics has claimed its first product approval, getting a green light from the FDA for Danyelza for the rare cancer neuroblastoma. It’s very exciting to see this treatment go from being an experimental therapy used at my daughter’s bedside to now being FDA approved,” said Gad, who is chairman and president of Y-mAbs. “I

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pharmaphorum

DECEMBER 29, 2021

Sanofi and Regeneron have another challenger to their big-selling drug Dupixent for atopic dermatitis, now that the FDA has approved Leo Pharma’s rival antibody tralokinumab. Dupixent’s label currently calls for dosing every two weeks for all patients. billion in 2020. billion in the same year.

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FDA Labelling 111

pharmaphorum

SEPTEMBER 23, 2022

The FDA has granted accelerated approval the RET inhibitor for all adults with locally advanced or metastatic solid tumours with a RET fusion mutation, two years after giving it a green light for RET-positive thyroid and lung cancers. The post Lilly bags label extension for RET drug Retevmo in US appeared first on.

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Labelling FDA 59

pharmaphorum

MAY 27, 2021

Myovant has chalked up a second approval for its flagship drug relugolix from the FDA, becoming the first once-daily oral drug in the US to treat heavy menstrual bleeding associated with uterine fibroids. . The post FDA clears Myovant’s relugolix for uterine fibroids, setting up AbbVie clash appeared first on.

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pharmaphorum

SEPTEMBER 20, 2021

Samsung Bioepis and Biogen have claimed the first FDA approval for a biosimilar version of Roche and Novartis’ Lucentis (ranibizumab) for leading causes of blindness, raising the prospect of a cheaper treatment option for US patients. billion respectively during 2020 as the pandemic reduced patient access to treatment.

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FDA Labelling 72

STAT

JANUARY 10, 2024

… In 2020, the U.S. Food and Drug Administration responded to decades of escalating concerns about Singulair, a widely prescribed drug for asthma and allergies, by adding a stark warning on the labeling that it could cause aggression, agitation and even suicidal thought. We enjoy hearing your tips and tidbits. in December.

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The FDA Law Blog

AUGUST 23, 2022

By doing so, FDA has limited the number of tests that have reached the market, thereby reducing available supply and increasing prices. As FDA would acknowledge, the antigen tests are the fastest and most practical method for distributing testing in the general population. That could happen again.

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pharmaphorum

DECEMBER 15, 2021

Apellis Pharma and partner Sobi have won EU approval for their paroxysmal nocturnal haemoglobinuria (PNH) drug pegcetacoplan in Europe, with a more restricted label than in the US. The post EU gives narrower label to Apellis, Sobi’s PNH drug appeared first on.

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Labelling FDA Immunization 52

The FDA Law Blog

APRIL 25, 2024

Promotional labeling is generally any labeling other than FDA-required labeling that is devised for the promotion of a product, as well as other functions, and can include printed, audio, or visual matter that describes the product. l)(1) (e.g.,

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Labelling Communication FDA 59

pharmaphorum

AUGUST 24, 2022

Amgen has reported positive phase 3 results with its biosimilar version of AstraZeneca/Alexion’s blockbuster rare disease drug Soliris, setting up a regulatory filing with the FDA. Samsung Bioepis is also developing a biosimilar version of Soliris called SB12, and reported results from its phase 3 trial earlier this year.

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Labelling FDA 98

The FDA Law Blog

JULY 10, 2023

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.

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pharmaphorum

AUGUST 9, 2021

Sanofi has added another string to its Pompe disease therapy bow, after getting FDA approval for Nexviazyme, its latest therapy for the rare, inherited disorder. In 2010, Lumizyme’s label was expanded to the under-right group as well.

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FDA Labelling 98

pharmaphorum

MAY 26, 2022

billion takeover of Agios Pharma’s oncology business after getting a key FDA approval for Tibsovo, the main asset in the deal. As Vidaza is a standard first-line therapy for AML the new indication makes Tibsovo an option for a wider range of patients, although the drug has reportedly been used off-label in this setting.

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FDA Chemotherapy Labelling 52

pharmaphorum

MAY 31, 2022

Roche and PTC Therapeutics’ Evrysdi for spinal muscular atrophy (SMA) has been approved by the FDA for younger children with the rare disease, extending its use to include infants less than two months of age. The post Roche puts pressure on SMA rivals with new FDA approval appeared first on.

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pharmaphorum

SEPTEMBER 15, 2021

The two FDA-approved oral GnRH antagonists – AbbVie and Neurocrine Biosciences’ Oriahnn (elagolix) and Myovant’s Pfizer-partnered Myfembree (relugolix) – are both combined with hormonal drugs. If approved, ObsEva’s drug will add another once-daily competitor to the ring.

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The FDA Law Blog

NOVEMBER 14, 2022

2022, FDA published a draft guidance on FDA’s implementation of the Over-the-Counter Monograph Drug User Fee Program (OMUFA). FDA is authorized to charge an annual facility fee for OTC monograph drug facilities. FDA will not refund any fees that have been incurred already). By Riëtte van Laack & Deborah L.

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Pharmaceutical Technology

FEBRUARY 21, 2023

The US Food and Drug Administration (FDA) has accepted a priority review of the biologics license application (BLA) for Regeneron Pharmaceuticals ’ pozelimab to treat children and adults with ultra-rare CHAPLE disease. The post US FDA accepts Regeneron’s pozelimab BLA for priority review appeared first on Pharmaceutical Technology.

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pharmaphorum

SEPTEMBER 24, 2021

The updated results come from the open-label RAINBOWFISH study, which investigate the effects of Evrysdi (risdiplam) in children from birth to six weeks who had yet to develop any symptoms of the muscle wasting disorder. Evrysdi is also on an upwards trajectory, bringing in around $250 million in the same period.

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Labelling FDA 97

The FDA Law Blog

OCTOBER 5, 2022

By Riëtte van Laack — On September 28, 2022, FDA announced the availability of the proposed rule for the implied nutrient content claim “healthy.” The term healthy, as an implied nutrient claim, was first defined by FDA in 1994. FDA also announced it would be re-evaluating the regulatory criteria for use of the “healthy” claim.

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FDA Labelling Packaging Documentation 52

pharmaphorum

OCTOBER 30, 2022

Shares in US biotech Y-mAbs Therapeutics have lost almost a third of their value after FDA advisors unanimously rejected its brain cancer therapy 131I-omburtamab in 16 to 0 vote. Changes in standard and supportive care over the time period could also have skewed the results, said the FDA reviewer.

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The FDA Law Blog

MAY 8, 2023

Javitt — FDA recently published a long-awaited draft guidance aimed at reducing the need for prior FDA authorization of modifications to artificial intelligence/machine learning (AI/ML)-enabled device software functions (ML-DSFs). Baumhardt, Senior Medical Device Regulation Expert & Philip Won & Gail H. See 21 CFR 807.81(a)(3)

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The Checkup by Singlecare

JULY 22, 2024

It can also treat parasitic infections, like giardia, and is frequently used off-label (for a non-FDA-approved use) to help treat Crohn’s disease, bite wounds, and oral infections. Be sure to check food labels carefully for either of these ingredients. What should you eat while taking metronidazole?

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Labelling Packaging FDA 105

pharmaphorum

NOVEMBER 15, 2021

Updated labelling for Invokana has already been approved to include data showing that it can reduce the risk of hospitalisation for heart failure and diabetic kidney disease in patients with type 2 diabetes, based on the CREDENCE trial. billion in 2016 before the product was linked to an increased risk of lower limb amputation.

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Labelling FDA 105

pharmaphorum

SEPTEMBER 11, 2020

But Kesimpta (ofatumumab), a repurposed cancer drug approved last month by the FDA, is seen as strong competition for Ocrevus thanks to a comparatively lower price and an injector pen that allows for home administration instead of in a clinic. billion in 2019 with more growth predicted this year.

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Labelling FDA 86

pharmaphorum

APRIL 29, 2022

Bristol-Myers Squibb’s has become the first company to bring a cardiac myosin inhibitor through to FDA approval, claiming a green light from the US regulator for mavacamten as a therapy for obstructive hypertrophic cardiomyopathy (HCM). The FDA approval was delayed b three months while the RENS was drawn up. Boxed safety warning.

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FDA Labelling 52

European Pharmaceutical Review

JULY 4, 2024

In the US, botanical dietary supplements can be sold without US Food and Drug Administration (FDA) approval, 1 prompting many vendors to promote the use of botanical products as dietary supplements , 2 rather than pursue a path of regulatory approval. 3 Is two too few? 3 Is two too few?

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pharmaphorum

OCTOBER 4, 2022

This week has seen two readouts for rivals from Clovis Oncology and Pfizer in prostate cancer – one of several indications on the Lynparza (olaparib) label – that could lead to a challenge to the $3 billion blockbuster.

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Chemotherapy Labelling FDA 52

pharmaphorum

OCTOBER 19, 2021

Biosimilar competition to AbbVie’s big-selling Humira drug in the US has just been ratcheted up by the FDA approval of Boehringer Ingelheim’s Cyltezo – which can be substituted for the reference drug without any prescriber intervention. The post FDA clears first “interchangeable” Humira biosimilar appeared first on.

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Hospital Pharmacy Europe

JUNE 12, 2023

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.

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pharmaphorum

JUNE 11, 2021

Bristol-Myer Squibb has only just won FDA approval for its CAR-T Breyanzi in large B-cell lymphoma (LBCL), but is already eyeing an expansion into earlier-line therapy that could overtake rival therapies from Novartis and Gilead Sciences. The post BMS will file for earlier-line use of Breyanzi in lymphoma after trial win appeared first on.

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The FDA Law Blog

AUGUST 10, 2022

Koblitz — For years , FDA has been wrestling with questions about what patents should be listed in the Orange Book, but, as we have reported, FDA has made little to no progress on addressing those questions. One of those pressing questions that remains unanswered involves the listing of REMS patents in the Orange Book.

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The Checkup by Singlecare

JANUARY 4, 2024

In addition, the FDA label 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.

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The People's Pharmacy

JUNE 12, 2023

If a patient wants to report an adverse reaction to the FDA, they need to fill out Form 3500B. It is rare for pharmacies to put the expiration date on the label if they transfer the pills from the manufacturer’s original container. After all, computers easily generate a date one year from the dispensing day when printing the label.

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Labelling Mail-Order Pharmacies Adverse Reactions FDA 62

The Checkup by Singlecare

AUGUST 8, 2024

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. The FDA says Zyrtec’s effects typically last around 24 hours for humans, and studies show that its elimination half-life is around 8.3 How quickly does Zyrtec work in dogs?

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The FDA Law Blog

JUNE 22, 2023

Mullen — FDA has been clearing over-the-counter (OTC) in vitro diagnostic (IVD) tests nearly since the beginning of its premarket regulation of devices. The first OTC IVD cleared by FDA was a qualitative dipstick urine glucose test in 1977, followed shortly thereafter by the first OTC pregnancy test clearance in 1978. lay users).

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Pharmaceutical Technology

DECEMBER 5, 2022

Notably, Lupkynis is the first oral therapy approved by the US Food and Drug Administration (FDA) and EC for the treatment of active LN. Overall, Aurinia’s Lupkynis is expected to face tough competition from Benlysta in LN, which received FDA approval in December 2020 and EMA approval in May 2021.

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Labelling FDA 59

The Checkup by Singlecare

DECEMBER 1, 2023

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.

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Labelling FDA Documentation 52