pharmaphorum

DECEMBER 23, 2020

It has been a year dominated by the pandemic and many life sciences research projects were put on hold as big pharma turned its attention to vaccines and therapies. The FDA has gone on to grant a fast review of the results ahead of a regulatory decision on the new lung cancer indication next year. months, compared with 6.7

FDA 96

FDA Chemotherapy Compounding Vaccines 96

European Pharmaceutical Review

JUNE 27, 2023

Of note, the US Food and Drug Administration (FDA) and ANSM (French regulatory authorities) have established themselves as early leaders to develop guidelines. Since these fresh FDA approvals for microbiome-based therapies, regulatory pathways are becoming clearer and opening new perspectives for companies.

Chemotherapy 105

Chemotherapy Immunization FDA Vaccines 105

pharmaphorum

JULY 19, 2021

Recent successes in FDA approvals of antibody–drug conjugates (ADCs), RNA therapeutics and the UK’s regulatory leadership in coronavirus vaccines show that complex medicines are having a global impact. But the benefits of complex medicines go far beyond those we have seen with these vaccines.

Vaccines 52

Vaccines Chemotherapy FDA 52

Pharmaceutical Technology

MARCH 2, 2023

Keytruda is indicated in patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) in patients whose tumors express PD-L1 and who have received at least one prior chemotherapy regimen. It is also indicated for the treatment of metastatic transitional (urothelial) tract cancer and gastric cancer.

Chemotherapy 40

Chemotherapy FDA Vaccines Immunization 40

Pharmaceutical Technology

JANUARY 30, 2023

The FDA approved fewer innovative drugs, New Molecular Entities (NMEs), in 2022 than it did in 2021: only 42 drugs compared to 59 drugs. Increased reluctance to authorise innovative and unproven drugs for use, stemming from the FDA’s experience with Aduhelm, reduced the overall novel approvals in 2022. months longer on the treatment.

FDA 52

FDA Chemotherapy Vaccines 52

pharmaphorum

NOVEMBER 14, 2022

GSK has had another setback in its oncology business, after the FDA asked it to restrict use of its PARP inhibitor Zejula in ovarian, fallopian tube, or primary peritoneal cancer to patients with a specific mutation. That was due last Friday, but cancelled when GSK opted to withdraw the approval.

Labelling 52

Labelling Chemotherapy FDA Vaccines 52

The Checkup by Singlecare

SEPTEMBER 12, 2024

Both are brand-name drugs approved by the Food and Drug Administration (FDA) and are given as subcutaneous injections. They also have different FDA approvals for some conditions. Enbrel is FDA approved for adults with rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, and plaque psoriasis.

Insurance 52

Insurance Dosage Vaccines Labelling 52

pharmaphorum

SEPTEMBER 8, 2020

In England for instance, the introduction of a biosimilar to prevent neutropenia in patients undergoing chemotherapy, resulted in a number of Strategic Health Authorities reassessing their guidance relating to this medicine. Unpleasant truth: let’s embrace it and take action.

Chemotherapy 99

Chemotherapy Patient Care Vaccines FDA 99

Hospital Pharmacy Europe

FEBRUARY 15, 2024

They are] administered by the same nurses who would normally give chemotherapy’, Dr Tucker says. However, she adds that ‘approaches using, for example, T-cell stimulating vaccines are currently being explored’. Undoubtedly, much more research, development and clinical applications of bispecific antibodies can be expected.

Chemotherapy 52

Chemotherapy Hospitals Immunization Vaccines 52

The Checkup by Singlecare

NOVEMBER 13, 2023

According to the CDC , treatment includes surgery, chemotherapy, radiation therapy, targeted therapy, or a combination of these treatments. To help decrease the risk of shingles, Shingrix vaccine is FDA-approved for adults 50 and older. It is a two-vaccine series and significantly decreases the risk of a shingles outbreak.

Mayo Clinic 52

Mayo Clinic Vaccines Chemotherapy Communication 52