The Checkup by Singlecare

NOVEMBER 6, 2023

Food and Drug Administration (FDA) just approved Wezlana (ustekinumab-auub), a biosimilar for the popular drug Stelara. According to the FDA announcement, the most serious side effect of Wezlana is infection because the prescription affects your immune response.

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pharmaphorum

MAY 27, 2021

If all goes well, CTP-543 could be ready for filing in early 2023, but even so it looks set to reach the AA market well behind Eli Lilly, which reported positive phase 3 results with its JAK 1/2 inhibitor Olumiant (baricitinib) earlier this year. Both Olumiant and CRP-543 have breakthrough designations from the FDA for this form of alopecia.

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pharmaphorum

APRIL 22, 2022

Ampio Pharma’s candidate therapy for knee osteoarthritis has been knocked back by the FDA, which will likely now require a new clinical trial of the drug before it will consider a review. The FDA said it should have been advised of the proposed changes before Ampio unblinded and analysed the data from the AP-013 study.

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Pharmacy Times

JUNE 20, 2025

Prior to October 2024, the Advisory Committee on Immunization Practices (ACIP) recommended use of a PCV only for all adults aged 65 years and older, including those aged 19 to 64 years with risk conditions for pneumococcal disease. Kobayashi M, Leidner AJ, Gierke R, et al. MMWR Morb Wkly Rep. 2025;74:1-8. doi:10.15585/mmwr.mm7401a1 3.

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The Checkup by Singlecare

NOVEMBER 26, 2024

Vitamin D Vitamin D coupons Most people think of vitamin D as the sunshine vitamin without realizing how big of an impact it has on our immune system. Low levels of vitamin D have been linked to poor immune function and fatigue, which can inhibit your recovery from COVID, says Simpson. Who should avoid vitamins for post-COVID fatigue?

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European Pharmaceutical Review

JUNE 27, 2023

AC Immune SA has received Fast Track designation from the US Food and Drug Administration (FDA) for its anti-amyloid beta (Abeta) active immunotherapy vaccine candidate for Alzheimer’s disease. The anti-Abeta therapy “specifically targets the most toxic forms of Abeta” according to Dr Andrea Pfeifer, CEO of AC Immune SA.

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pharmaphorum

OCTOBER 27, 2022

Santhera has completed a rolling application for its Duchenne muscular dystrophy (DMD) therapy vamorolone in the US, setting up a possible approval and launch in the latter half of 2023. Its lead drug has already claimed fast track and rare paediatric disease designations from the FDA.

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The Checkup by Singlecare

SEPTEMBER 22, 2023

Here’s what you need to know about the new FDA-approved RSV vaccine. But young children, older adults, and individuals with weakened immune systems are at high risk of severe, potentially life-threatening RSV illness. The RSV vaccines are not mRNA immunizations, and “they are not live vaccines,” explains Blair Gingerich , Pharm.D.,

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PharmaShots

MARCH 24, 2023

PTC Therapeutics’ Upstaza (eladocagene exuparvovec) Receives NICE Recommendation for the Treatment of AADC Deficiency Date: Mar 24, 2023 | Tags: PTC Therapeutics, Upstaza, eladocagene exuparvovec, AADC Deficiency, Regulatory, NICE Onconova Therapeutics Entered into a Research Collaboration with Pangea Biomed to Identify Biomarkers for Cancer (..)

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Pharmacy Times

JANUARY 5, 2024

Adalimumab-aqvh (Yusimry; Coherus Biosciences) entered the market in July 2023, following approval by the FDA in December 2021.

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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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pharmaphorum

APRIL 29, 2021

Calliditas Therapeutics could have its first product on the market in the US this autumn, as the FDA has now started a priority review of Nefecon for rare disease primary IgA nephropathy (IgAN). . The post FDA sets September review date for Calliditas’ rare kidney disease drug appeared first on.

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PharmaShots

APRIL 7, 2023

TG Therapeutics Receives EMA’s CHMP Positive Opinion of Briumvi (ublituximab-xiiy) for the Treatment of Relapsing Forms of Multiple Sclerosis Date: Apr 3, 2023 | Tags: TG Therapeutics, Briumvi, Ublituximab-xiiy, Multiple Sclerosis, Regulatory, EMA, CHMP BMS Receives EMA’s CHMP Positive Opinion of Breyanzi (lisocabtagene maraleucel) for (..)

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Pharmaceutical Technology

APRIL 14, 2023

This will suppress the effector characteristics in multiple immune cell subsets. Tiziana Life Sciences chief medical officer Matthew Davis said: “We anticipate entering into a Phase 2a placebo-controlled clinical trial upon successful feedback from the FDA.

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The FDA Law Blog

APRIL 8, 2024

Claud — CDER’s Office of Pharmaceutical Quality (OPQ) issued its 2023 Annual Report last week, and it’s an upbeat assessment of the Office’s policy and outreach efforts. Drug shortages have been a scourge for FDA , both as they negatively affect consumers and FDA’s reputation. By John W.M.

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Pharmaceutical Technology

JANUARY 10, 2023

On November 17, 2022, the FDA approved Provention Bio’s Tzield (teplizumab) , making it the first and only treatment to delay the onset of type 1 diabetes (T1D). These therapies work by reprogramming the immune system, preventing it from attacking and eradicating insulin-producing cells in the pancreas. Equity in early-stage testing.

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PharmaShots

APRIL 19, 2023

Shots: The US FDA approved 6 NDAs and 1 BLA in March 2023, leading to treatments for patients and advances in the healthcare industry. The therapy is expected to be available in July 2023 The approval was based on 2 pivotal studies evaluating Zavzpret. early time point EPs (relieve pain within 15-30 min.,

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European Pharmaceutical Review

NOVEMBER 3, 2023

This decreases the activity of parts of the immune system that are involved in the inflammation of hair follicles that causes hair loss in people with alopecia areata.

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Pharmaceutical Technology

NOVEMBER 14, 2022

In lupus, the body’s immune system starts to attack its own cells. Saphnelo is also being studied in a Phase III trial in lupus nephritis, where a person’s immune system targets the kidneys, eventually leading to kidney failure. Several other investigational therapies are expected to have material updates in 2023.

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European Pharmaceutical Review

JUNE 30, 2023

Roctavian, an adeno-associated virus (AAV) vector-based gene therapy is the first to be approved by the US Food and Drug Administration (FDA) for adults with severe haemophilia A. The gene therapy is authorised for individuals without pre-existing antibodies to adeno-associated virus serotype 5 detected by an FDA-approved test.

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Pharmaceutical Technology

APRIL 3, 2023

Tango Therapeutics has received clearance from the US Food and Drug Administration (FDA) for its investigational new drug (IND) application for TNG260 to treat STK11-mutant cancers. It is in preclinical development to reverse immune evasion in STK11 mutated cancers.

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European Pharmaceutical Review

MAY 4, 2023

Overall, the mechanisms of action for amivantamab include ligand blocking, receptor degradation, and immune cell-mediated activity. 4 BsMAb amivantamab was designed to enhance adherence of tumour cells to macrophages and natural killer cells, to improve immune-cell mediated killing of cancer cells. Personalized medicine at FDA.

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PharmaShots

JANUARY 27, 2023

Magenta Therapeutics Pauses the P-I/II Study in AML Patients Date: Jan 27, 2023 | Tags: Magenta Therapeutics, MGTA-117, AML, Clinical Trial, P-I/II Ipsen Receives CHMP Negative Opinion for Palovarotene to Treat Fibrodysplasia Ossificans Progressiva Date: Jan 27, 2023 | Tags: Ipsen, Palovarotene, Fibrodysplasia Ossificans Progressiva, Regulatory, CHMP, (..)

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Pharmaceutical Technology

MAY 4, 2023

The US Food and Drug Administration (FDA) approved Kamada’s application to manufacture Cytogam (cytomegalovirus immune globulin intravenous [human]) at its facility located in Beit Kama, Israel. It is claimed to be the only immunoglobulin (IgG) product to receive FDA approval for this indication.

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Pharmaceutical Technology

MARCH 27, 2023

Food and Drug Administration (FDA) for Lifileucel. Lifileucel is a tumour infiltrating lymphocyte (TIL) therapy for patients with advanced melanoma who do not respond to immune checkpoint inhibitors. Marc Hurlbert, CEO of the Melanoma Research Alliance (MRA) said he hopes for a quick FDA approval.

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The Checkup by Singlecare

DECEMBER 31, 2024

Prednisone is an FDA-approved prescription medication to treat a range of common conditions characterized by inflammation caused by the immune system. Like other steroids, prednisone reduces swelling, redness, and other symptoms caused by immune system reactions.

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PharmaShots

MAY 12, 2023

Sanofi Reports P-IIIb Trial (HARMONIE) Results of Nirsevimab for the Prevention of Hospitalizations due to RSV-Related LRTD Date: May 12, 2023 | Tags: Sanofi, Nirsevimab, RSV-Related LRTD, Clinical Trial, P-IIIb, HARMONIE Trial G1 Therapeutics Presents Preliminary Results from P-II Trial of Trilaciclib for Triple-Negative Breast Cancer at ESMO 2023 (..)

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Pharmaceutical Technology

FEBRUARY 26, 2023

While the French MaaT Pharma has submitted further information to the FDA, its trial remains on hold. In January 2023, Finch announced plans to scrap the PRISM4 trial altogether. In November 2022, Ferring Pharmaceuticals’s Rebyota became the first FDA-approved microbiome-based therapeutic to treat recurrent CDI. with placebo.

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Hospital Pharmacy Europe

AUGUST 23, 2023

A human CD40 agonistic antibody targeting CD40, mitazalimab kickstarts the cancer-immunity cycle by priming and activating tumour-specific T cells. The EMA orphan drug designation follows a similar approval by the FDA in May 2023. Targeting CD40 with mitazalimab has the potential to augment responses to chemotherapy.

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PharmaShots

MARCH 24, 2023

PTC Therapeutics’ Upstaza (eladocagene exuparvovec) Receives NICE Recommendation for the Treatment of AADC Deficiency Date: Mar 24, 2023 | Tags: PTC Therapeutics, Upstaza, eladocagene exuparvovec, AADC Deficiency, Regulatory, NICE Onconova Therapeutics Entered into a Research Collaboration with Pangea Biomed to Identify Biomarkers for Cancer (..)

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Hospital Pharmacy Europe

AUGUST 24, 2023

The the first and only treatment indicated to reduce proteinuria in adults with primary IgAN at risk of rapid disease progression, budesonide was approved by the FDA in 2021 under the accelerated approval scheme. IgA nephropathy is a chronic immune-mediated kidney disease characterised by IgA deposition in the glomeruli.

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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. If the results are positive, Concert could be ready to file for approval in 2023. All three drugs have breakthrough designations from the FDA for this indication.

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PharmTech

JUNE 10, 2025

s CDC Vaccine Committee Overhaul for the Pharmaceutical Industry June 10, 2025 By Christopher Cole News Article The dismissal of all 17 members of the Advisory Committee on Immunization Practices has far-reaching impacts for the industry and beyond. ACIP plays a foundational role in shaping immunization policy in the US. Kennedy Jr.

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pharmaphorum

NOVEMBER 18, 2022

At its second attempt, Provention Bio has secured FDA approval for teplizumab, as a treatment to delay late-stage type 1 diabetes (T1D) in at-risk individuals – becoming the first disease-modifying therapy for these patients. It is now in line for a $35 million equity investment by Sanofi following FDA approval.

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Pharmaceutical Technology

APRIL 26, 2023

The US Food and Drug Administration (FDA) has granted orphan drug designation to IN8bio’s INB-400 and INB-410 to treat a range of malignant gliomas, including newly diagnosed glioblastoma multiforme (GBM). Participant enrolment is anticipated to commence in the second half of 2023.

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Pharmaceutical Technology

JUNE 15, 2023

Alentis Therapeutics has received US Food and Drug Administration (FDA) clearance for its investigational new drug (IND) application for ALE.C04 to treat Claudin-1 positive (CLDN1+) tumours. The planned Phase I/II clinical trial in HNSCC will begin in the second half of 2023.

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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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