pharmaphorum

AUGUST 16, 2022

AstraZeneca and Merck & Co’s PARP inhibitor Lynparza is already used to treat prostate cancer associated with a specific genetic mutation, but could see its use broadened if a new marketing application is approved by the FDA. Rubraca was approved in 2020 for BRCA1/2 mutated mCRPC, and is in two phase 3 trials to extend its label.

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FDA Labelling 106

European Pharmaceutical Review

AUGUST 23, 2022

A study of the causes of warning letters issued by the US Food and Drug Administration (FDA)’s Center for Drug Evaluation and Research (CDER) and Center for Devices and Radiological Health (CDRH) between 2010 and 2020 revealed that poor current good manufacturing practice (cGMP) compliance and misbranding were the most common citations.

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FDA Documentation Packaging Labelling 91

STAT

SEPTEMBER 13, 2023

Akili Interactive, which in 2020 made waves by receiving Food and Drug Administration clearance for its video game that improves symptoms of ADHD in children, on Wednesday announced it would reorient its business around selling its products directly to users over the counter, rather than by prescription.

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Labelling FDA 120

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

pharmaphorum

JANUARY 12, 2021

Boehringer and Eli Lilly have moved closer to a heart failure indication for their SGLT2 inhibitor Jardiance, as the FDA starts a fast-track review of the drug in its first use beyond diabetes. Farxiga won FDA approval for adults with HFrEF in May 2020, which helped to drive its third-quarter sales up by a third to $525 million.

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Labelling FDA 70

pharmaphorum

AUGUST 27, 2020

Already under fire for what some view as a premature authorisation of convalescent plasma for COVID-19, the FDA is now being accused of a blunder that could render current supplies unusable.

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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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FDA Labelling Immunization 52

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

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

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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FDA Labelling 92

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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pharmaphorum

FEBRUARY 23, 2022

The FDA has issued a complete response letter to Mallinckrodt for terlipressin, on the grounds that the company had been forced to change its packaging and labelling manufacturing facility for the drug. The post FDA knocks back Mallinckrodt’s kidney drug terlipressin appeared first on.

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FDA Packaging Labelling 59

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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FDA Documentation Packaging Communication 75

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 109

pharmaphorum

DECEMBER 18, 2020

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. The post GSK’s Benlysta claims first FDA okay for lupus kidney damage appeared first on.

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FDA Labelling 82

pharmaphorum

DECEMBER 14, 2022

An FDA advisory committee has voted against approval of Cytokinetics’ cardiac myosin inhibitor omecamtiv mecarbil for heart failure, saying the data for the drug was not strong enough. The post FDA adcomm votes down Cytokinetics heart failure drug appeared first on. There was also no impact on quality-of-life measures.

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FDA Documentation Labelling 52

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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Labelling Communication FDA Medical Schools 97

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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FDA Labelling 98

pharmaphorum

JUNE 7, 2021

Kymriah (tisagenlecleucel) was approved for relapsed/refractory ALL in 2017, but its label covers use in children and young adults aged up to 25, who account for the bulk of cases of the blood cancer. It was filed for the adult ALL indication in the US in April, and has a priority review from the FDA, with a verdict due in October.

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pharmaphorum

FEBRUARY 5, 2021

The FDA has said it will wait for additional results from last week’s trial showing an increased risk of cardiac side effects with Pfizer’s arthritis blockbuster Xeljanz before deciding on further action. billion in the first nine months of 2020, up 10% overall and 23% in ex-US markets.

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FDA Communication Labelling Patient Care 58

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

pharmaphorum

SEPTEMBER 15, 2022

Mallinckrodt has finally claimed FDA approval for terlipressin as a treatment for hepatorenal syndrome (HRS), after manufacturing problems scuppered an earlier attempt. The drug is already approved for this indication in dozens of other countries around the world, including much of Europe, Australia and New Zealand.

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FDA Packaging Labelling 93

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

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

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 93

The Checkup by Singlecare

OCTOBER 12, 2023

Abilify generic | Abilify vs. aripiprazole | Cost | Off-label use | How to switch Abilify is a brand-name medication approved to treat certain mental health conditions, including the treatment for schizophrenia , bipolar disorder , and major depressive disorder. Abilify first received FDA approval in 2002. mL, 960 mg/3.2

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Dosage Labelling FDA Adverse Reactions 52

PharmaShots

FEBRUARY 6, 2023

Shots: The company reported the results from the PoC P-II open-label (UNITY) trial evaluating nipocalimab (IV, qw) in 14 patients who are at high risk for sev. HDFN The trial met its 1EPs i.e., the results showed that patients treated with nipocalimab achieved a live birth at or after the gestational age of 32wks.

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Labelling FDA 40

pharmaphorum

JUNE 15, 2022

Manufacturing problems wreaked havoc with Mallinckrodt’s first attempt to secure FDA approval of its treatment candidate terlipressin for hepatorenal syndrome (HRS), but the drugmaker is having another attempt. There is no FDA-approved therapy available. billion settlement in 2020 which was finally accepted earlier this year.

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FDA Packaging Labelling 59

The Checkup by Singlecare

SEPTEMBER 7, 2023

Lexapro was approved by the United States Food and Drug Administration (FDA) in 2002. In 2020, an estimated 6.3 Brand-name medicines must go through extensive testing to prove they are safe and effective before they are approved by the FDA. In fact, the FDA conducts a rigorous review to make sure these requirements are met.

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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

FEBRUARY 8, 2024

Zyrtec was approved by the United States Food and Drug Administration (FDA) in 1995. The first generic of prescription Zyrtec, cetirizine, was approved by the FDA in 2008, around the time the medication became available over the counter. For example, one 2020 study from Taiwan compared brand-name and generic antidepressants.

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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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FDA Labelling Hospitals 59

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

Pharmaceutical Technology

JUNE 12, 2023

A US Food and Drug Administration (FDA) Advisory Committee (AdCom) has unanimously voted in support of Eisai and Biogen’s Leqembi and its clinical benefit in patients with early Alzheimer’s disease , raising the drug’s full approval prospects. Notably, an FDA AdCom voted largely against Aduhelm in November 2020.

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Medical Schools FDA Labelling 52

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

pharmaphorum

APRIL 22, 2022

The write-down comes in the wake of problems affecting the Japanese drugmaker’s AT132 gene therapy candidate for rare disease X-linked myotubular myopathy (XLMTM), which was placed on clinical hold by the FDA last year after four patient deaths liked to possible liver-related side effects.

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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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FDA Labelling 92