Pharmacy Times

OCTOBER 1, 2024

Ustekinumab is a human monoclonal antibody targeting the cytokines interleukin (IL)-12 and IL-23, which play a rule in the inflammatory and immune responses.

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Immunization FDA 139

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

Fierce Pharma

OCTOBER 16, 2023

Up until this point, immune checkpoint inhibitors have been allowed to treat early-stage non-small cell lung cancer (NSCLC) either before or after surgery. Thanks to a new FDA approval for Merck's Keytruda, a continuous immunotherapy regimen around surgery is now available for patients with early-stage non-small cell lung cancer.

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FDA Labelling Immunization 131

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

JULY 12, 2024

RSVpreF is currently the only FDA-approved RSV vaccine for pregnant individuals.

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Immunization Vaccines FDA 101

Hospital Pharmacy Europe

JULY 17, 2023

Immune checkpoint inhibitors have transformed the management of non-small cell lung cancer, but how long should treatment be continued for optimal survival? It has long been recognised that a hallmark of cancer is immune evasion and that the immune system is held back by inhibitory immune checkpoint receptors and ligands.

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Immunization Hospitals FDA 98

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

Pharmaceutical Technology

JULY 25, 2024

JNJ-2056 is being investigated in the Phase IIb ReTain study which enrols participants who are yet to show Alzheimer’s symptoms.

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Immunization Vaccines FDA 98

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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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

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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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

Pharmacy Times

SEPTEMBER 20, 2024

The approval enables more convenient flu immunization options for patients.

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Immunization Vaccines FDA 111

pharmaphorum

DECEMBER 19, 2022

The US Food and Drug Administration (FDA) has approved Swiss drugmaker Ferring Pharmaceuticals’ Adstiladrin (nadofaragene firedenovec-vncg) for the treatment of adult patients with high-risk Bacillus Calmette-Guérin (BCG)-unresponsive non-muscle-invasive bladder cancer (NMIBC) with carcinoma in situ (CIS), with or without papillary tumours.

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FDA Dosage Immunization 119

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

Fierce Pharma

OCTOBER 20, 2023

approval for the first five-pronged meningitis vaccine, Pfizer has eked out a regulatory win well ahead of its immunization rival GSK. | FDA gave a thumbs-up to Penbraya, the commercial moniker for Pfizer’s pentavalent vaccine defending against the most common serogroups behind meningococcal disease. In the race to secure U.S.

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FDA Vaccines Immunization 98

Pharmacy Times

JUNE 23, 2022

Vaxneuvance was approved for an expanded indication by the FDA on June 22, 2022, for active immunization in children 6 weeks of age and older.

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Immunization Vaccines FDA 123

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

European Pharmaceutical Review

DECEMBER 19, 2022

The US Food and Drug Administration (FDA) has approved Adstiladrin (nadofaragene firadenovec-vncg) as the first gene therapy for non-muscle-invasive bladder cancer (NMIBC) in adults with high-risk Bacillus Calmette-Guérin (BCG)-unresponsive with carcinoma in situ (CIS) with or without papillary tumours.

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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

The Checkup by Singlecare

NOVEMBER 23, 2022

Food and Drug Administration (FDA) approved the first drug to delay the onset of Type 1 diabetes. Tzield received priority review from the FDA, a status given to drugs with the potential for “significant improvement” in the treatment, diagnosis, or prevention of a serious condition. 17, the U.S. That’s where Tzield comes in.

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Fierce Pharma

MARCH 25, 2024

The four years since the start of the COVID-19 pandemic have yielded many advances against the coronavirus, including Moderna and Pfizer’s groundbreaking mRNA vaccines. |

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Immunization Vaccines FDA 94

European Pharmaceutical Review

NOVEMBER 28, 2022

Fast Track designation (FTD) has been granted for REM-001 therapy to treat unresectable cutaneous metastatic breast cancer (CMBC) by the US Food and Drug Administration (FDA). The post FDA Fast Track designation for photodynamic cancer therapy appeared first on European Pharmaceutical Review.

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FDA Chemotherapy Immunization 98

pharmaphorum

OCTOBER 21, 2021

The FDA has authorised booster shots with Moderna and Johnson & Johnson’s COVID-19 vaccines, a month after giving the go-ahead to a third-dose of Pfizer/BioNTech’s shot. The FDA has followed that advice. The post FDA okays Moderna, J&J COVID jab boosters, plus ‘mix and match’ appeared first on.

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FDA Vaccines 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

The Checkup by Singlecare

DECEMBER 26, 2024

Over 40 new medications have been approved by the FDA, giving patients more options for treating various health problems. Zelsuvmi (berdazimer) Zelsuvmi received the green light from the FDA on January 5, 2024. Zelsuvmi’s approval is a big deal because it’s only the second FDA-approved treatment for this condition.

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FDA Dosage Immunization Hospitals 52

STAT

OCTOBER 8, 2024

Moreover, the trade group maintained the FDA move was “unlawful,” because it failed to follow so-called rule-making procedures and provide proper notice of its plans. In the late 1990s, the FDA raised concerns the vaccine lost potency toward the end of its 24-month shelf life. ” A U.S. from 1967 until 2022.

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Compounding FDA Compounding Pharmacies Vaccines 91

Pharmaceutical Technology

JULY 29, 2022

The Food and Drug Administration (FDA) has acc epted to review ImmunityBio’s Biologics License Application (BLA) for N-803 to treat Bacillus Calmette-Guérin (BCG)-unresponsive non-muscle-invasive bladder cancer (NMIBC) carcinoma in situ (CIS) patients with or without Ta or T1 disease.

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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 10, 2022

The FDA may have safety concerns abut bluebird bio’s gene therapy for rare, fatal disease cerebral adrenoleukodystrophy (CALD), but its advisors believe its benefits far outweigh the risks. The post FDA panel backs bluebird’s CALD gene therapy, despite safety worries appeared first on.

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Digital Pharmacist

OCTOBER 26, 2022

Food and Drug Administration (FDA) announced its approval of the Boostrix vaccine, commonly known as Tdap (combination of Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis) for immunization administration during the third trimester of pregnancy to prevent pertussis in infants younger than two months of age.

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Vaccines FDA Hospitals Immunization 98