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Thursday, May 16
by
SRN News
US FDA approves Amgen drug for small cell lung cancer
(Reuters) -The U.S. Food and Drug Administration on Thursday granted accelerated approval to Amgen’s tarlatamab, a targeted immunotherapy for treating adults with advanced small cell lung cancer that has worsened despite chemotherapy. The therapy, marketed under the name Imdelltra, is part of Amgen’s pipeline ...
Wednesday, May 15
by
SRN News
US FDA approves expanded use of Bristol Myers’ cancer cell therapy
(Reuters) -The U.S. health regulator on Wednesday approved the expanded use of Bristol Myers Squibb’s cancer cell therapy Breyanzi for the treatment of adults with a type of blood cancer called follicular lymphoma, that has returned or has not responded to prior treatments. The Food ...
Wednesday, May 15
by
SRN News
US FDA approves expanded use of Bristol’s cancer cell therapy
(Reuters) -The U.S. health regulator said on Wednesday it has approved the expanded use of Bristol Myers Squibb’s cancer cell therapy Breyanzi for the treatment of adults with a type of blood cancer that has returned or has not responded to prior treatments. The Food ...
Wednesday, May 15
by
SRN News
Getinge limits sale of heart devices in the US after FDA warning
(Reuters) – Sweden’s Getinge will limit sales of some of its heart products in the U.S., the medical equipment maker said late on Tuesday, after recent advice from the U.S. Food and Drug Administration (FDA) to move away from its ...
Wednesday, May 15
by
SRN News
Roche says FDA approves HPV self-test in US
BERLIN (Reuters) – Swiss drugmaker Roche on Wednesday said the US Food and Drug Administration (FDA) has approved its human papillomavirus (HPV) self-testing kit. Screening for HPV can help identify women who are at risk of developing cervical cancer at ...
Tuesday, May 14
by
SRN News
Eisai starts rolling submission for injectable version of Alzheimer’s drug with US FDA
(Reuters) – Eisai and partner Biogen said on Tuesday that the Japanese drugmaker has begun submitting data on a rolling basis to the US health regulator for a marketing application of a subcutaneous form of their Alzheimer’s disease drug Leqembi. The ...
Tuesday, May 14
by
SRN News
US FDA extends review of Ascendis Pharma’s hormone disorder therapy
(Reuters) -The U.S. Food & Drug Administration has extended its review of Ascendis Pharma’s therapy to treat adult patients with a hormone disorder by three months, the company said on Tuesday. U.S.-listed shares of the company were down 6.6% in late afternoon trading. The health ...
Tuesday, May 14
by
SRN News
FDA extends review of Ascendis Pharma’s hormone disorder therapy
(Reuters) – The U.S. Food & Drug Administration has extended its review of Ascendis Pharma’s therapy to treat adult patients with a hormone disorder, the company said on Tuesday. The FDA is now set to make its decision known by Aug. ...
Tuesday, May 14
by
SRN News
US FDA declines expanded use of Dynavax’s hepatitis B vaccine on insufficient data
By Christy Santhosh and Pratik Jain (Reuters) -The U.S. drug regulator has declined to approve expanded use of Dynavax Technologies’ hepatitis B vaccine in a section of patients, citing insufficient data over destruction of some trial documents, the company said on Tuesday. The Food and Drug ...
Tuesday, May 14
by
SRN News
US FDA declines expanded use of Dynavax’s hepatitis B vaccine on insufficient data
By Christy Santhosh and Pratik Jain (Reuters) -The U.S. drug regulator has declined to approve expanded use of Dynavax Technologies’ hepatitis B vaccine in a section of patients, citing insufficient data over destruction of some trial documents, the company said on Tuesday. The Food and Drug ...
Tuesday, May 14
by
SRN News
US FDA declines to approve expanded use of Dynavax’s hepatitis B vaccine
(Reuters) -Dynavax Technologies said on Tuesday the U.S. Food and Drug Administration (FDA) has declined to approve the expanded use of its hepatitis B vaccine in patients undergoing hemodialysis, citing insufficient safety and effectiveness data. The FDA, in its so-called “complete response letter”, stated that ...
Friday, May 10
by
SRN News
Final tests of US dairy samples are negative for bird flu virus, US FDA says
CHICAGO (Reuters) – Final testing of U.S. retail dairy samples came back negative for viable H5N1 bird flu virus, the Food and Drug Administration said on Friday. The FDA said it finished its laboratory research into 297 retail dairy samples tested ...
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