The FDA Law Blog

APRIL 30, 2023

Senate Committee on Health, Education, Labor and Pensions (“Senate HELP”) is scheduled to take up legislation that could significantly limit access to the courts and immunize critical FDA decisions from timely judicial review. Subsection 505(q) initially was added by Section 914 of the 2007 FDA Amendments Act (“FDAAA”), Pub.

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The Checkup by Singlecare

MAY 16, 2024

From a breakthrough drug to standard-of-care treatment, Remicade (infliximab) has a storied history of treating autoimmune disease —when the immune system mistakenly identifies healthy tissues as foreign and initiates an attack. Inflectra Approved by the FDA in 2016, Inflectra (infliximab-dyyb) was the first biosimilar to Remicade.

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Pharmaceutical Technology

OCTOBER 25, 2022

The US Food and Drug Administration (FDA) has granted approval for AstraZeneca ’s Imjudo (tremelimumab) plus Imfinzi (durvalumab) to treat adults with unresectable hepatocellular carcinoma (HCC), a kind of liver cancer.

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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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Digital Pharmacist

OCTOBER 24, 2022

The FDA protects public health by ensuring the efficacy and safety of human and veterinary drugs, including biological products and medical devices. It is critical for the FDA to continue to develop new advances in therapies to aid our communities in order to achieve better lives through better health. Date of Approval: 9/30/2022.

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pharmaphorum

AUGUST 4, 2021

At the moment, the condition can only be managed using powerful corticosteroid drugs, which suppress the immune system but can have serious side effects if used long-term. All three drugs have breakthrough designations from the FDA for this indication.

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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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The Checkup by Singlecare

MARCH 22, 2024

When the immune system overreacts, it leads to inflammation and symptoms like itching and irritation of the skin. This can help calm down the immune system and control eczema symptoms. Because these medicines suppress the immune system, they can make you more susceptible to infections. It can also be used to treat RA.

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Pharmaceutical Technology

JUNE 16, 2023

Avenge Bio has obtained orphan drug designation from the US Food and Drug Administration (FDA) for its AVB-001 to treat mesothelioma patients. In March 2023, the FDA provided positive feedback on Avenge Bio’s preclinical and clinical development initiatives for pleural malignant mesothelioma.

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pharmaphorum

DECEMBER 24, 2021

Fresh from being awarded a fast-track review from the FDA, Boehringer Ingelheim’s spesolimab has shown encouraging efficacy in a phase 2 trial in generalised pustular psoriasis (GPP), a rare and life-threatening skin disorder.

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Pharmaceutical Technology

MAY 26, 2023

After earning multimillion dollar revenues while being an authorised preferred treatment for Covid-19, the US Food and Drug Administration (FDA) has granted a full approval to Pfizer’s oral antiviral Paxlovid (nirmatrelvir + ritonavir).

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The Checkup by Singlecare

DECEMBER 1, 2023

Vitamin D also supports a healthy immune system and can even help prevent diseases. That is 170% of the daily value (DV) recommended by the US Food and Drug Administration (FDA). Department of Agriculture (USDA) requires it to be labeled “farmed” or” wild-caught.” Exposure to sunlight is one of the best ways to get vitamin D.

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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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The Checkup by Singlecare

JULY 8, 2024

Rinvoq works by lowering your immune system activity,” said Joanne Nguyen, Pharm.D. , By suppressing a specific pathway in the immune system, Rinvoq reduces inflammation and relieves symptoms associated with inflammatory conditions. Boxed warnings are the most serious warnings issued by the FDA for medications.”

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pharmaphorum

APRIL 30, 2021

The BCMA-targeting CAR-T – also known as cilta-cel – has been filed with the EMA as a treatment for adults with relapsed/refractory multiple myeloma, an incurable form of blood cancer, a few months after it was submitted to the FDA for the same indication. BMS and bluebird had been hoping for a label allowing third-line use.

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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. Effects on the immune system Alcohol may negatively affect your immune system’s ability to fight off infections, especially in people who drink large amounts over time.

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The Checkup by Singlecare

MAY 8, 2024

The role of Remicade for ulcerative colitis Infliximab is an antibody that intercepts one of the key messengers of the immune system’s signaling pathway. With the immune system not using resources to fight a war on its own body, our systems can devote more proteins and energy to daily living.

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pharmaphorum

JANUARY 19, 2023

Alopecia areata is an autoimmune disease in which the immune system attacks the body’s hair follicles, causing hair to fall out, predominantly on the scalp, but also sometimes affecting other areas of the body like eyebrows, eyelashes, and facial hair. The $11.50

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Pharmaceutical Technology

NOVEMBER 13, 2022

The US Food and Drug Administration (FDA) has granted approval for AstraZeneca ’s Imfinzi (durvalumab) plus Imjudo (tremelimumab) and platinum-based chemotherapy to treat Stage IV (metastatic) non-small cell lung cancer (NSCLC) in adults.

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pharmaphorum

SEPTEMBER 16, 2022

. “Treating with Opdivo in earlier stages of cancer, when the immune system may be more responsive, has the potential to help prevent recurrence – a critical goal of improving patient outcomes,” she said in a statement.

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The Checkup by Singlecare

MAY 24, 2024

Its use in cats is “off-label,” meaning that the U.S. Food and Drug Administration ( FDA ) has not approved the drug for use in companion animals. Over a short time, the immune system ends the infection by killing off the remaining bacteria. Treatment lasts only a few days, with relatively minimal potential side effects.

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The Checkup by Singlecare

APRIL 3, 2024

It is used to control inflammation by suppressing the immune system,” says Jelena Radan, Pharm.D. According to a 2017 study , the beverage acts in an anti-inflammatory manner on different components of the immune system, such as natural killer (NK) cells, monocytes, and neutrophils. ” These may be taken without food.

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Pharmaceutical Technology

APRIL 12, 2023

The US Food and Drug Administration (FDA) has approved Takeda ’s supplemental Biologics Licence Application (sBLA) to expand the use of its HyQvia subcutaneous immune globulin (ScIG) for the treatment of primary immunodeficiency (PI) in children aged between two and 16 years.

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pharmaphorum

SEPTEMBER 18, 2020

But the findings of the latest phase 3 study, EMPACTA, could change that after Roche said it plans to share results with the FDA and other regulators to get its label expanded on the basis of the latest results. The study did not identify any new safety signals for Actemra/RoActemra.

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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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pharmaphorum

MARCH 27, 2022

The decision comes less than a month after Carvykti was approved by the FDA as a fifth-line therapy for multiple myeloma, teeing up a tussle in the market with Bristol-Myers Squibb and bluebird bio spinout 2seventy’s Abecma (idecabtagene autoleucel) which was approved for a similar indication last year.

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pharmaphorum

FEBRUARY 7, 2022

Sanofi has won FDA approval for its sutimlimab for cold agglutinin disease (CAD) at the second time of asking, becoming the first approved therapy for the rare blood disorder in the US. It is also being developed for other indications including immune thrombocytopenic purpura.

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The Checkup by Singlecare

FEBRUARY 23, 2024

Others take ashwagandha to improve cognitive function or boost the immune system. Food and Drug Administration (FDA), there is no official guidance on how much to take. Taking the supplement at night can reduce the impact of any potential side effects, such as drowsiness or stomach upset. appeared first on The Checkup.

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pharmaphorum

AUGUST 25, 2021

The 15-valent conjugate vaccine was at least as effective as Pfizer’s 13-valent Prevnar 13 in the study, which involved infants up to 15 months old, and will form the basis of regulatory filing to extend the label for Vaxneuvance later this year, according to Merck.

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The Checkup by Singlecare

OCTOBER 30, 2023

Food and Drug Administration (FDA) to treat a wide range of respiratory bacterial infections, such as pneumonia and bronchitis , as well as infections of the ear , nose, throat , urinary tract infections , and skin. Amoxicillin food interactions According to the amoxicillin product labeling , there are no drug-food interactions of concern.

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The Checkup by Singlecare

NOVEMBER 30, 2023

Acetaminophen may also blunt the effects of other medications that impact the immune system, including some medicines used to manage cancer diagnoses and even the immune response following vaccinations. In some cases, metyrapone is used off-label in the treatment of Cushing syndrome.

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The Checkup by Singlecare

SEPTEMBER 13, 2024

Stelara (ustekinumab) is an injectable drug approved by the Food and Drug Administration (FDA) for the treatment of autoimmune conditions, such as plaque psoriasis, active psoriatic arthritis, and inflammatory bowel diseases, including Crohn’s disease , and ulcerative colitis. There are no known food-drug interactions with Stelara.

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Pharmaceutical Technology

JULY 28, 2022

While the exact cause of UC remains unknown, it is often associated with immune system malfunction. One potential benefit of cobitolimod’s unique route of administration is that local administration via rectal enema has the potential to limit systemic absorption and the immune-related side effects that plague some marketed agents.

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European Pharmaceutical Review

SEPTEMBER 22, 2023

Limitations of monoclonal antibody therapies Regulatory approvals from the US Food and Drug Administration (FDA) for aducanumab and lecanemab – and likely very soon for donanemab also – opened a route for different therapeutic modalities and other relevant disease targets, such as tau.

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The Checkup by Singlecare

JULY 8, 2024

It’s part of the immune system’s defense mechanism, but it can cause serious issues—like rheumatoid arthritis and psoriatic arthritis—if it gets too severe. The Food and Drug Administration (FDA) prescribing information for Rinvoq states that, during clinical trials, Rinvoq only caused weight gain in around 2% of patients.

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Hospital Pharmacy Europe

SEPTEMBER 29, 2022

RP2 oncolytic therapy involves genetically engineered viruses designed to target and kill cancer cells while sparing normal cells and activating the host immunity to recognise and attack the tumour. Consequently, blockage of CTLA-4 function promotes immune-mediated tumour regression. T-VEC was also approved by the EMA in 2016.

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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. A chemical created by the immune system, histamines react when they encounter an allergen like pollen, dust, or mold. How quickly does Zyrtec work in dogs?

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