pharmaphorum

AUGUST 21, 2022

Shares in Axsome Therapeutics have rocketed on FDA approval of its depression therapy Auvelity (formerly AXS-05) – a year after its approval was held up by the regulator. That status goes to Johnson & Johnson’s Spravato (esketamine), which was approved in March 2019 and is administered as a nasal spray twice a week for four weeks.

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FDA Labelling 96

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

JULY 20, 2021

The FDA has taken a longer than usual look at Ardelyx’ regulatory submission for tenapanor, a drug for high blood phosphate levels associated with chronic kidney disease (CKD), and found it wanting – sending the biotech’s shares into a tailspin. “Despite….advantageous “Despite….advantageous

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FDA Labelling Communication 98

pharmaphorum

AUGUST 18, 2021

The FDA has approved GlaxoSmithKline’s latecomer PD-1 inhibitor Jemperli for a second use that will significantly extend the patient population eligible for treatment with the drug. billion takeover of Tesaro in 2019. The post GSK claims broader ’tissue-agnostic’ label for PD-1 drug Jemperli appeared first on.

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Labelling FDA 52

pharmaphorum

JANUARY 4, 2023

Retail pharmacies in the US will be able to dispense mifepristone-based therapies to end pregnancies after the FDA introduced changes to its regulatory framework for the products. The American College of Obstetricians and Gynaecologists (ACOG) said the FDA’s decision was a victory for women’s health.

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FDA Labelling 88

pharmaphorum

JULY 26, 2021

Fresh from its takeover of Alexion, AstraZeneca has picked up a recommendation in the EU for an expansion of the label of Ultomiris, one of the main assets behind the $39 billion merger. Ultomiris was approved by the FDA for use in paediatric PNH last month.

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Labelling FDA 52

pharmaphorum

SEPTEMBER 2, 2021

The FDA has concluded its safety review of Pfizer’s JAK inhibitor Xeljanz and Xeljanz XR, requiring revised warnings for the drugs as well as others in the class after finding evidence of elevated risks of serious heart-related events. The post FDA firms up JAK inhibitor warnings after Xeljanz review appeared first on.

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FDA Labelling 52

pharmaphorum

AUGUST 4, 2021

The HDAC inhibitor was given an accelerated approval by the FDA as a second-line PTCL therapy on the strength of overall response data, but a phase 3 study comparing Istodax to first-line chemotherapy showed no improvement on progression-free survival (PFS).

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FDA Chemotherapy Labelling 98

pharmaphorum

JANUARY 10, 2022

Swiss biotech Idorsia has claimed FDA approval for its first product – insomnia treatment Quviviq – setting up a market challenge to class rivals from Merck & Co and Eisai. Belsomra’s first-to-market advantage hasn’t translated into big annual sales, which have stayed planted just over the $300 million mark since 2019.

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FDA Labelling 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. Sales reached a peak in 2019, when Roche booked $1.8 billion, but fell back to $1.4

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FDA Labelling 72

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

The Checkup by Singlecare

MARCH 12, 2024

If you see medications labeled “Advil” and others labeled “ibuprofen,” you may ask yourself: “Is Advil the same as ibuprofen?” NSAIDs are FDA-approved pain medications that can decrease fever and inflammation. You may also want to know: Does Advil have ibuprofen in it? What does Advil and ibuprofen treat?

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Labelling FDA Medication Labelling 97

The FDA Law Blog

JUNE 11, 2023

However, one piece, excerpted below, stood out to us: Historically, FDA has at times issued WRs solely for studies required under PREA, even if there were no other indications that may produce health benefits in the pediatric population. However, over time, data on pediatric labeling changes pursuant to BPCA and/or PREA have been collected.

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Labelling FDA 40

pharmaphorum

AUGUST 16, 2021

Merck & Co has extended its range of cancer medicines in the US after claiming FDA approval for Welireg – a drug it acquired as part of its $2.2 billion takeover of Peloton Therapeutics in 2019 – for a family of rare tumours. Merck paid $1.05 billion upfront to secure rights to Welireg, and also pledged another $1.15

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Labelling FDA 98

The Checkup by Singlecare

DECEMBER 21, 2023

But since its FDA approval for the treatment of Type 2 diabetes back in 1994, metformin has emerged as something of a “miracle drug” thanks to its effectiveness in treating other common health conditions, like infertility, obesity , and heart disease. Metformin is a medication commonly used to treat people with Type 2 diabetes.

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Health and Personal Care Stores Labelling Dosage FDA 105

pharmaphorum

MAY 25, 2022

Roivant group company Dermavant has made the transition to a commercial-stage company after getting FDA approval for Vtama, a drug for psoriasis that it claims could be a game-changer in the treatment of the skin disorder. The post Dermavant claims its first approval as FDA clears psoriasis drug appeared first on.

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FDA Labelling 52

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

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. The post FDA holds back from action over Xeljanz safety study appeared first on.

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FDA Communication Labelling Patient Care 58

pharmaphorum

FEBRUARY 23, 2021

The FDA is to begin a fast review of Incyte’s Jakafi (ruxolitinib) for patients with chronic graft-versus-host disease (GVHD), which cannot be treated with steroids. The post FDA to quickly review Incyte’s Jakafi in chronic GVHD appeared first on.

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FDA Labelling 60

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

The FDA Law Blog

FEBRUARY 16, 2023

Richardson — On February 15, 2023, the Nonprescription Drugs Advisory Committee (NDAC) and the Anesthetic and Analgesic Drug Products Advisory Committee (AADPAC) held a joint meeting to discuss an application pending before FDA that would switch Narcan (naloxone) Nasal Spray from prescription to over-the-counter (OTC) status.

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Labelling Packaging FDA 64

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

MARCH 1, 2021

European regulators have refused to back GlaxoSmithKline’s daily triple therapy Trelegy Ellipta for asthma, denying a label extension because there was no evidence to show a reduction of flare-ups. GSK’s problems with Trelegy, developed in partnership with Innoviva, stem from the phase 3 CAPTAIN study , which reported findings in May 2019.

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Labelling FDA 105

pharmaphorum

NOVEMBER 30, 2021

The FDA has kicked off its review of Bristol-Myers Squibb’s psoriasis therapy deucravacitinib, setting an action date of 1 September next year, as the EU and Japanese regulators also start their appraisals of the drug. The post FDA sets Sept review date for BMS’ psoriasis drug deucravacitinib appeared first on.

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FDA Labelling 52

pharmaphorum

SEPTEMBER 11, 2022

Bristol-Myers Squibb’s deucravacitinib– one of the main pipeline assets in its $74 billion takeover of Celgene in 2019 – has been approved in its first market as a treatment for moderate-to-severe plaque psoriasis. billion oral psoriasis therapy Otezla (apremilast). Otezla was acquired by Amgen for $13.4

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Labelling FDA Immunization 52

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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FDA Documentation Labelling 98

The Checkup by Singlecare

FEBRUARY 5, 2024

Food and Drug Administration (FDA) for relief of mild, intermittent asthma symptoms, like wheezing, cough, shortness of breath, and chest tightness. It is approved and labeled for use in patients 12 and older who have been previously diagnosed with asthma. OTC inhalers are approved by the U.S.

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Labelling FDA Dosage 52

The Checkup by Singlecare

DECEMBER 28, 2023

Although Ozempic has been approved by the Food and Drug Administration (FDA) since 2017, its status as a household name is relatively recent. Weight loss is an off-label , non-FDA-approved use for Ozempic. The FDA has urged consumers to use caution when taking medication from these compound pharmacies.

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Insurance Insurance Coverage FDA Documentation 104

pharmaphorum

JULY 9, 2021

According to the EMA’s pharmacovigilance risk assessment committee (PRAC), labelling for Pfizer/BioNTech’s Comirnaty and Moderna’s Spikevax should be updated to reflect “very rare cases” of myocarditis and pericarditis with the shots. . The therapy hasn’t yet been approved by the FDA.

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Vaccines Labelling FDA Immunization 105

The People's Pharmacy

MARCH 20, 2023

Over the past several years, the FDA has approved a number of injectable medications designed to help people with type 2 diabetes control their blood sugar. Like liraglutide, this injectable medication acts like glucagon in the body ( Frontiers in Endocrinology , April 12, 2019 ). Another Question About Ozempic: Q.

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Adverse Reactions Labelling FDA 64

pharmaphorum

JUNE 6, 2022

The results have set up a pre-filing meeting with the FDA, according to BMS. Rozlytrek was approved by the FDA in 2019 but has just started to gather sales momentum, making around $17 million in the first quarter of this year, an increase of 78% on the first three months of 2021.

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Chemotherapy FDA Labelling 97

pharmaphorum

OCTOBER 25, 2021

The new approval is the first breast cancer indication for Keytruda in Europe, although elsewhere Merck has already started to expand the label for its cancer immunotherapy in TNBC. The US and Japanese regulators approved the Keytruda plus chemo regimen for first-line TNBC treatment earlier this year.

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Chemotherapy FDA Labelling 87

The Checkup by Singlecare

AUGUST 29, 2023

Food and Drug Administration (FDA) in 2012 as a brand-name drug. Although a generic was approved in 2019, generic apixaban will not be available on the market until at least April 2028. The first generics of apixaban were announced in December 2019. This is called off-label prescribing. Eliquis was approved by the U.S.

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Dosage Insurance Labelling FDA 52

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

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

The Checkup by Singlecare

APRIL 25, 2024

Labeled as a controlled substance , Adderall contains amphetamine and dextroamphetamine. Food and Drug Administration ( FDA ). The FDA explains that their regulations require a proposed expiration date for medications to be approved. Pharmaceuticals have expiration dates. Adderall falls into this category.

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FDA Controlled Substances Labelling 105

pharmaphorum

NOVEMBER 10, 2022

Sales were around $140 million in 2019, and climbed to $165 million the following year, despite the impact of the pandemic. With finances tight, Clovis has deferred a $1.9 million interest payment on debt, and is now in a 30-day grace period that could lead to it being in default.

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Chemotherapy Labelling FDA 59