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FDA Pushes Review Date For Ascendis Pharma's Hormone Disorder Candidate By Three Months
Benzinga via Yahoo Finance· 13 hours agoTuesday, Ascendis Pharma A/S (NASDAQ:ASND) announced that the FDA extended the review date for...
FDA approves self-collection screening for virus that causes cervical cancer - The Boston Globe
The Boston Globe· 10 hours ago“It provides women who might not have otherwise had the opportunity — or inclination — to get...
FDA Delays Decision on Ascendis' (ASND) Hormone Therapy Filing
Zacks via Yahoo Finance· 16 hours agoPer the FDA, the data submitted by Ascendis (ASND) for its hormone replacement therapy constitutes a...
Throw out COVID-19 tests made by Cue Health, FDA warns
WJZY via Yahoo News· 9 hours agoCue Health, headquartered in San Diego, received emergency use FDA authorization for two COVID-19...
Q1 2024 Abeona Therapeutics Inc Earnings Call
Thomson Reuters StreetEvents via Yahoo Finance· 34 minutes agoWe now stay resolutely focused on working with the FDA to address the CMC deficiencies noted in the CRL and making the BLA resubmission toward bringing Pz-cel to order patients ...
FDA greenlights self-collection of vaginal samples for cervical cancer screening
CNN.com· 10 hours agoTwo health care businesses – biotechnology company Roche and medical technology firm Becton, Dickson...
FDA approves HPV self-test kit
UPI· 15 hours agoEach year, about 11,500 U.S. women are diagnosed with cervical cancer and about 4,000 women die from it, according to the U.S. Centers for Disease...
FDA Concludes that Tara Flour is Not GRAS
The National Law Review· 14 hours agoFood and Drug Administration FDA publishes assessment concluding that tara flour does not meet generally recognized as safe GRAS as unapproved food...
FDA approves self-collection screening tests for HPV, allowing women to avoid pelvic exams for...
FierceBiotech· 16 hours agoThe FDA has approved two diagnostic devices that allow women to collect vaginal samples themselves...
...Keeping Track of Your Data — What You Need to Know about FDA’s Draft Guidance on Data Integrity...
The National Law Review· 12 hours agoGiven data integrity issues that have been uncovered in the past, in April 2024, the U.S. Food and...
