pharmaphorum4 天
FDA approves etectRx 'digital pill' as rivals struggle
The FDA has approved an ingestible event marker from the privately-held digital health company etectRx, as its rival “digital pill” company Proteus faces financial difficulties. Florida-based ...
pharmaphorum4 天
FDA changes its mind and approves Takeda’s Eohilia
In its second attempt, Takeda has secured FDA approval for Eohilia ... antibody Dupixent (dupilumab), which was approved for the condition in 2022. Faced with the cost of a second trial, the ...
RFK Jr’s No. 1 hurdle to take on unhealthy food: money
Robert F. Kennedy Jr. has pledged to transform America’s food system, vowing to crack down on foods and ingredients he blames ...
Targeted Oncology3 天
FDA Approves Revumenib in KMT2A-Rearranged Acute Leukemia
The FDA has granted approval to revumenib for the treatment of adult and pediatric patients with relapsed/refractory KMT2A-rearranged acute leukemia. 1 Data from the phase 1/2 AUGMENT-101 trial, as ...
Are Diabetes Drugs Really Safe (& Reliable) for Weight Loss?
There’s been lots of attention on type 2 diabetes drugs recently, especially since they might also be able to support weight ...
FiercePharma24 天
After prior rejection, Iterum nabs long-sought FDA nod for oral UTI drug Orlynvah
Back in April, the FDA approved Utility Therapeutics’ Pivya (pivmecillinam). The penicillin antibiotic underpinning Utility’s drug had never before been cleared in the U.S., despite being ...
FierceBiotech24 天
FDA approves Medtronic's Affera all-in-one pulsed field ablation system
Less than a year after obtaining an FDA ... 2022 through its $925 million purchase of the device’s eponymous developer. Not long thereafter, in early 2023, the company claimed a European ...
The American Journal of Managed Care10 天
FDA Approves Obe-Cel for R/R B-Cell Acute Lymphoblastic Leukemia
Obe-cel is the first FDA-approved CAR T-cell therapy for B-ALL without a REMS requirement, based on the FELIX trial's positive outcomes. The FELIX trial reported a 63% complete remission rate ...
The American Journal of Managed Care4 天
FDA Approves Gene Therapy to Treat AADC Deficiency
Eladocagene exuparvovec is the first US-approved gene therapy for AADC deficiency, administered directly to the brain. Clinical trials showed significant motor and cognitive improvements ...
Cure Today27 天
FDA Approval of Trodelvy Withdrawn for Urothelial Carcinoma
The withdrawal of the FDA accelerated approval for locally advanced or metastatic urothelial carcinoma, a type of bladder cancer, does not affect other indications of the therapy. Gilead Sciences ...
Arkansas Legislative Council subcommittee recommends implementation of diabetes management ...
An Arkansas Legislative Council subcommittee has recommended that the state's health insurance plans for public school and ...
Pharmaceutical Technology26 天
FDA approves Alvotech and Teva’s SELARSDI for new indications
Credit: BlurryMe/Shutterstock. The US Food and Drug Administration (FDA) has approved a new presentation of Alvotech and Teva Pharmaceuticals’ SELARSDI (ustekinumab-aekn), expanding its label to ...