PharmaVoice

MAY 1, 2025

The company has predicted that Imaavy — now approved for myasthenia gravis — could eventually earn more than $5 billion in annual sales at its peak.

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Immunization FDA 100

STAT

JUNE 28, 2024

The New York-based biotech said the FDA asked for only “limited” additional information. ” The rejection is another setback for a class of gene therapies that have held tremendous promise for patients with rare blood and immune disorders but have proven exceptionally difficult to manufacture and scale.

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FDA Immunization 126

Fierce Pharma

JANUARY 16, 2024

The FDA has approved Takeda's HyQvia as a maintenance therapy for CIDP. It is the second indication for HyQvia, which was first endorsed in 2014.

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Immunization FDA 93

Pharmacy Times

SEPTEMBER 18, 2024

Eosinophilic granulomatosis with polyangiitis is a rare and immune-mediate vasculitis that can damage multiple organs and be fatal if left untreated.

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Immunization FDA 132

Pharmacy Times

AUGUST 16, 2024

Durvalumab is a human monoclonal antibody that targets and binds to PD-L1 to interrupt tumor immune-evasion tactics.

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Immunization FDA 139

Pharmafile

APRIL 14, 2023

Pharma giant Eli Lilly’s Biologic Licence Application (BLA) for its bowel disease drug has been declined by the FDA over concerns about the proposed manufacturing of the drug. However, concerns weren’t expressed over the clinical data package, safety or label for the medicine.

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FDA Packaging Labelling Immunization 119

Pharmacy Times

APRIL 17, 2024

Ustekinumab (Stelara; Janssen Immunology) is a human monoclonal antibody that treats immune-mediated diseases such as psoriasis and psoriatic arthritis.

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Immunization FDA 144

Pharmacy Times

SEPTEMBER 20, 2024

Amivatamab-vmjw is a fully-human bispecific antibody targeting EGFR and MET with immune cell-directed activity.

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Immunization FDA 132

Pharmacy Times

MARCH 25, 2024

The indication is for adults and adolescents with moderate to severe immune compromise due to medical conditions or immunosuppressive medications and treatments.

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Immunization FDA 139

STAT

AUGUST 21, 2023

The Food and Drug Administration on Monday approved a Pfizer vaccine that aims to protect newborns against RSV by vaccinating pregnant people in the latter part of pregnancy. The vaccine, Abrysvo, has also been approved for use in adults 60 and older to protect them against respiratory syncytial virus. Read the rest…

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Vaccines Immunization FDA 98

European Pharmaceutical Review

NOVEMBER 18, 2022

Tzield (teplizumab-mzwv), the first drug to help prolong the onset of stage 3 type 1 diabetes in adults and children over eight years old with stage 2 type 1 diabetes, has been approved by the US Food and Drug Administration (FDA). The drug binds to certain immune system cells and delays progression to stage 3 type 1 diabetes.

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FDA Immunization 98

pharmaphorum

JANUARY 26, 2022

Immunocore has secured a piece of biotech industry history, becoming the first company to get an FDA approval for a cancer therapeutic based on T cell receptor (TCR) technology. The post Immunocore claims first-ever FDA approval for TCR cancer therapy appeared first on.

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FDA Chemotherapy Labelling Immunization 124

pharmaphorum

DECEMBER 9, 2020

Reviewers from the FDA have given their blessing to the Pfizer/BioNTech COVID-19 vaccine ahead of a key meeting tomorrow – but the regulator noted that there are still uncertainties about whether the shot can stop the disease from spreading. The post FDA reviewers back Pfizer/BioNTech COVID-19 vaccine ahead of panel appeared first on.

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Vaccines FDA Adverse Reactions Documentation 111

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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FDA Immunization 110

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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FDA Immunization 111

STAT

FEBRUARY 16, 2024

Nearly four decades after its first conception, the first TIL therapy, an immunotherapy that harvests cancer-fighting immune cells from the patient’s own body, received accelerated approval from the Food and Drug Administration for advanced melanoma.

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FDA Immunization 145

pharmaphorum

OCTOBER 18, 2021

An FDA advisory committee voted unanimously in favour of a booster dose of Johnson & Johnson’s one-shot COVID-19 vaccine on Friday, as panellists suggested it should have been used as a two-dose regimen from the start. The post FDA panel backs booster shot for J&J COVID-19 vaccine appeared first on.

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Vaccines FDA Immunization 97

pharmaphorum

DECEMBER 30, 2021

Johnson & Johnson’s much-touted crop of bispecific antibodies for cancer generated its first commercial product in May, and the drugmaker has now filed for FDA approval of a second candidate. “We look forward to working with the FDA in their review of our teclistamab submission.”

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FDA Chemotherapy Immunization 122

European Pharmaceutical Review

AUGUST 2, 2024

The US Food and Drug Administration (FDA) has granted accelerated approval for the cell therapy TECELRA ® (afamitresgene autoleucel) to treat adults with unresectable or metastatic forms of the disease. The post FDA approves innovative engineered cell therapy appeared first on European Pharmaceutical Review.

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FDA Chemotherapy Immunization 98

pharmaphorum

MARCH 11, 2021

Vertex Pharma has made its name with treatment for cystic fibrosis, but has big plans in cell and genetic therapies – and has just chalked up fast-track status from the FDA for a cell-based therapy for diabetes. . The post FDA fast tracks type 1 diabetes cell therapy from Vertex appeared first on.

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FDA Immunization 98

pharmaphorum

DECEMBER 15, 2021

Bristol-Myers Squibb’s rheumatoid arthritis drug Orencia has been approved by the FDA to prevent graft versus host disease (GvHD), a serious complication of haematopoietic stem cell transplant (HSCT) used to treat leukaemias and other blood cancers. billion in the first nine months of the year.

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FDA Immunization 105

Pharmacy Times

JUNE 16, 2023

Glofitamab targets CD3, a protein found on the surface of immune T cells in patients with relapsed or refractory diffuse large B-cell lymphoma, and CD20, a healthy or malignant protein that lines the surfaces of B cells.

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Immunization FDA 123

STAT

OCTOBER 26, 2023

The therapy, dubbed Omvoh, is an antibody that blocks IL-23p19, an immune signaling molecule that plays a key role in sustaining the disease. It’s the first treatment to target this particular pathway in ulcerative colitis.

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FDA Insurance Immunization 132

Pharmaceutical Technology

FEBRUARY 20, 2023

The US Food and Drug Administration (FDA) has granted approval for Apellis Pharmaceuticals’ Syfovre (pegcetacoplan injection) to treat geographic atrophy (GA), an advanced form of age-related macular degeneration (AMD). The post US FDA approves Apellis’ geographic atrophy therapy Syfovre appeared first on Pharmaceutical Technology.

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pharmaphorum

JUNE 11, 2021

Sanofi’s hopes of a speedy approval of first-in-class C1s inhibitor sutimlimab in rare disorder cold agglutinin disease (CAD) were dashed by the FDA, but new phase 3 data keep the drugmaker on track for a resubmission before year-end. Sutimlimab, which Sanofi acquired via its $11.6

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FDA Immunization Labelling 96

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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Immunization FDA Labelling 59

Pharmafile

MARCH 22, 2023

Faron Pharmaceuticals, a clinical stage biopharmaceutical company, has revealed positive FDA feedback and recommendations for its monotherapy for solid tumour drug, bexmarilimab. read more

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FDA Immunization 78

STAT

MAY 18, 2023

But on a second question — whether the available data support the safety of immunization with this vaccine — the committee voted 10-4. Read the rest…

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Vaccines Immunization FDA 109

Pharmafile

JULY 26, 2024

Clinical-stage biopharmaceutical company AC Immune announced that the US Food and Drug Administration (FDA) has granted its Alzheimer’s disease (AD) candidate ACI-35.030 (now called JNJ-2056) Fast Track designation. ACI-35.030 is an active-immunotherapy targeting phosphorylated Tau (pTau).

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FDA Immunization 64

Pharmaceutical Technology

MAY 2, 2023

The FDA recently announced the expansion of the emergency use authorizations (EUAs) of both Pfizer/BioNTech’s and Moderna’s bivalent original/Omicron BA.4/5 1 vaccines by both companies were revoked by the FDA in August 2022, after the BA.5 4/5 Covid-19 messenger RNA (mRNA) vaccines. The EUAs for the bivalent original/Omicron BA.1

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Vaccines FDA Immunization 21

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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Immunization Hospitals FDA 94

The Checkup by Singlecare

FEBRUARY 22, 2024

Food and Drug Administration (FDA) extended its prior approval of Xolair (omalizumab) to treat accidental exposure to food allergens. The most recent extension approved the medication to treat IgE-mediated food allergy, meaning food allergy involving an immune system reaction that begins quickly after ingesting the allergen.

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FDA Immunization 103

Fierce Pharma

AUGUST 18, 2023

Along with resolving site inspection issues that cost Regeneron a high-dose Eylea launch in June, the company has scored an FDA nod for Veopoz as the first treatment for the ultra-rare inherited im | Alongside a Friday approval for its ultra-rare disease medicine Veopoz, Regeneron now expects a high-dose Eyelea nod in the next few weeks after resolving (..)

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Immunization FDA 71

Hospital Pharmacy Europe

FEBRUARY 23, 2023

The complement system is a component of the immune system that is central to the detection and destruction of invading pathogens and consists of three pathways. The post FDA approves Syfovre for geographic atrophy in advanced age-related macular degeneration appeared first on Hospital Pharmacy Europe.

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Pharmaceutical Technology

DECEMBER 13, 2024

The US FDA has accepted Sobi North Americas avatrombopag (DOPTELET) sNDA to treat paediatric immune thrombocytopenia.

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FDA Immunization 59

STAT

JANUARY 26, 2023

Notably, Evusheld — unlike other antibody therapies — was not for infected patients, but rather was given as a pre-exposure treatment to people at high risk for severe Covid-19, such as those with compromised immune systems. Read the rest…

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Immunization FDA 102

pharmaphorum

OCTOBER 27, 2022

Santhera should hear from the FDA whether the speedy review has been granted within the next 60 days, and if so the review time will be cut from 10 to six months. Its lead drug has already claimed fast track and rare paediatric disease designations from the FDA.

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FDA Immunization 98