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FDA Took Months to React to Complaint About Abbott's Formula Factory, Audit Finds
MedPage Today· 4 days agoThe FDA took more than 15 months to act on a whistleblower complaint it received about conditions at...
AstraZeneca/Fibrogen’s Roxadustat FDA Review Further Delayed Following Unanticipated Advisory...
Clinical Trials Arena via Yahoo Finance· 22 hours agoFDA Delays Decision on AstraZeneca/Fibrogen’s Roxadustat for CKD Anemia On March 1, AstraZeneca and...
More people sent to hospital as mushroom-infused 'microdosing' chocolate faces ongoing FDA probe
Fox News via Yahoo News· 1 day agoThe FDA recently announced that 10 consumers who ate Diamond Shruumz "microdosing" chocolate and...
Merck Get FDA Approval for Keytruda to Treat Endometerial Cancer
Morningstar· 5 hours agoMerck said its blockbuster cancer drug Keytruda has been approved for the treatment of adult patients with primary advanced or recurrent endometrial carcinoma. The Food and Drug Administration ...
FDA creates transparency principles for AI in medical devices
MedTech Dive via Yahoo Finance· 17 hours agoThe agency worked with regulators in the U.K. and Canada to determine how key information about...
FDA halts trial of BioNTech-MediLink ADC over 'significant risk of illness'
FierceBiotech· 14 hours agoThe FDA has slammed the brakes on MediLink Therapeutics’ trial of a BioNTech-partnered antibody-drug...
What Does FDA's Draft Platform Guidance Mean For CGT Companies?
BioresearchOnline· 20 hours agoThe U.S. FDA released the much-anticipated draft guidance Platform Technology Designation Program...
FDA approves Amgen’s BLINCYTO for acute lymphoblastic leukaemia
Pharmaceutical Technology via Yahoo Finance· 19 hours agoThe US Food and Drug Administration (FDA) has approved Amgen’s BLINCYTO (blinatumomab) for...
Novavax seeks FDA approval for updated Covid-19 vaccine
Pharmaceutical Technology via Yahoo Finance· 19 hours agoNovavax has submitted an application to the US Food and Drug Administration (FDA) seeking approval...
FDA Panel Votes Against MDMA-Assisted Talk Therapy | JD Supra
JD Supra· 9 hours agoOn June 4, 2024, a panel of experts advising the Food and Drug Administration (FDA) on the use of the psychedelic midomafetamine (MDMA) for post-traumatic stress disorder ...