WebMD22d
FDA Approves New Immunotherapy for Aggressive Leukemia
The FDA has approved a new treatment, Aucatzyl, for a type of aggressive blood cancer called B-cell acute lymphoblastic leukemia (B-cell ALL). This treatment, a CAR T-cell immunotherapy ...
MedPage Today29d
FDA Approves New Option for Rosacea
Opens in a new tab or window Share on LinkedIn. Opens in a new tab or window The FDA approved minocycline hydrochloride extended-release capsules (Emrosi) for treating inflammatory lesions of ...
The American Journal of Managed Care8d
FDA Approves Acoramidis for ATTR-CM
Acoramidis is the first FDA-approved treatment for ATTR-CM with near-complete TTR stabilization, reducing cardiovascular death and hospitalization. The phase 3 ATTRibute-CM trial showed acoramidis ...
MedPage Today12d
FDA Approves Zanidatamab for Biliary Tract Cancer
Opens in a new tab or window Share on LinkedIn. Opens in a new tab or window The FDA on Wednesday granted accelerated approval to zanidatamab (Ziihera), a bispecific antibody, for pretreated HER2 ...
pharmaphorum2d
FDA changes its mind and approves Takeda’s Eohilia
In its second attempt, Takeda has secured FDA approval for Eohilia, which becomes the first and only oral therapy in the US for eosinophilic oesophagitis (EoE). The US regulator has cleared ...
Business Wire1mon
FDA Approves Novocure’s Optune Lua® for the Treatment of Metastatic Non-Small Cell Lung Cancer
Optune Lua is a wearable, portable, FDA-approved device used together with PD-1/PD-L1 inhibitors (immunotherapy) or docetaxel. It is indicated for adult patients with metastatic non-small cell ...
Reuters25d
US FDA approves Johnson & Johnson's device for heart condition
Nov 7 (Reuters) - The U.S. Food & Drug Administration has approved Johnson & Johnson's (JNJ.N), opens new tab device for a type of condition which causes abnormal heart rhythm, the company said on ...
Cure Today25d
FDA Approves CAR-T Cell Therapy for Relapsed or Refractory B-Cell ALL
The CAR-T cell therapy Aucatzyl was approved for relapsed or refractory B-cell precursor acute lymphoblastic leukemia based on findings from the FELIX trial. The Food and Drug Administration (FDA) ...
Yahoo Finance27d
FDA Approves Renewal of Canalevia-CA1, Jaguar Health's Drug for Chemotherapy-Induced Diarrhea in Dogs
After collecting the remaining effectiveness data, the company then applies to the FDA for full approval. The FDA reviews the application and, if appropriate, fully approves the drug.
The American Journal of Managed Care25d
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 ...
PharmiWeb27d
FDA Approves Renewal of Canalevia-CA1, Jaguar Health's Drug for Chemotherapy-Induced Diarrhea in Dogs
The FDA reviews the application and, if appropriate, fully approves the drug. According to the American Veterinary Medical Association, approximately 1 in 4 dogs will, at some stage in their life, ...