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Fetal Harm Articles & Analysis

6 news found

FDA Approves Taiho’s LYTGOBI® (futibatinib) Tablets for Previously Treated, Unresectable, Locally Advanced or Metastatic Intrahepatic Cholangiocarcinoma

FDA Approves Taiho’s LYTGOBI® (futibatinib) Tablets for Previously Treated, Unresectable, Locally Advanced or Metastatic Intrahepatic Cholangiocarcinoma

Initiate a low-phosphate diet and phosphate-lowering therapy when serum phosphate level is ≥5.5 mg/dL; initiate or intensify phosphate-lowering therapy when >7 mg/dL; reduce dose, withhold, or permanently discontinue LYTGOBI based on duration and severity of hyperphosphatemia. Embryo-fetal Toxicity:LYTGOBI can cause fetal harm. Advise ...

ByTaiho Oncology, Inc.


AVEO Oncology Presents Three Posters for Tivozanib/Immunotherapy Combinations at the 2022 ASCO GI Cancers Symposium

AVEO Oncology Presents Three Posters for Tivozanib/Immunotherapy Combinations at the 2022 ASCO GI Cancers Symposium

Reversible Posterior Leukoencephalopathy Syndrome (RPLS): Discontinue FOTIVDA if signs or symptoms of RPLS occur. Embryo-Fetal Toxicity: Can cause fetal harm. Advise patients of the potential risk to a fetus and to use effective contraception. ...

ByAVEO Pharmaceuticals, Inc.


AVEO Oncology Highlights Recent Progress and 2022 Outlook

AVEO Oncology Highlights Recent Progress and 2022 Outlook

Reversible Posterior Leukoencephalopathy Syndrome (RPLS): Discontinue FOTIVDA if signs or symptoms of RPLS occur. Embryo-Fetal Toxicity: Can cause fetal harm. Advise patients of the potential risk to a fetus and to use effective contraception. ...

ByAVEO Pharmaceuticals, Inc.


Thermo Fisher Scientific and Daiichi Sankyo to Co-Develop Global Companion Diagnostic for Patients with Non-Small Cell Lung Cancer

Thermo Fisher Scientific and Daiichi Sankyo to Co-Develop Global Companion Diagnostic for Patients with Non-Small Cell Lung Cancer

Permanently discontinue ENHERTU in patients with symptomatic congestive heart failure. Embryo-Fetal Toxicity ENHERTU can cause fetal harm when administered to a pregnant woman. ...

ByThermo Fisher Scientific, LIMS & Laboratory Software


BlueWillow Receives FDA Clearance to Begin Phase 1 Study of its Intranasal Anthrax Vaccine

BlueWillow Receives FDA Clearance to Begin Phase 1 Study of its Intranasal Anthrax Vaccine

Evidence indicates the current vaccine may cause acute side effects, as well as the risk of potential fetal harm if administered to pregnant women. “The BlueWillow/PBL anthrax vaccine has the potential to provide significant advantages over the current injectable vaccine,” said BlueWillow CEO Dave Peralta. ...

ByBlueWillow Biologics


FDA Approves BAVENCIO (avelumab) plus Axitinib Combination for Patients with Advanced Renal Cell Carcinoma

FDA Approves BAVENCIO (avelumab) plus Axitinib Combination for Patients with Advanced Renal Cell Carcinoma

Axitinib Important Safety Information from the US FDA Approved Label In the study of advanced RCC after failure of one prior systemic therapy, the warnings and precautions for axitinib include hypertension, including hypertensive crisis, arterial and venous thrombotic events, hemorrhagic events, cardiac failure, gastrointestinal perforation and fistula, hypothyroidism, wound healing ...

BySiemens AG

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