FDA grants a de novo marketing authorization for Cue Healths Cue Covid-19 Molecular Test, the first at-home Covid test granted a traditional marketing...
Norwich Pharmaceuticals asks the DC federal court to order FDA to grant final approval to the companys amended ANDA for generic rifaximin to treat irr...
PhRMA says it generally agrees with recommendations in an FDA draft guidance on notification of a permanent discontinuance or interruption in drug man...
CDER and Oncology Center of Excellence researchers say a pooled analysis showed the frontline immune-oncology/tyrosine kinase inhibitor combination th...
FDA issues an import alert on drug products manufactured by Sun Pharmaceutical Industries in Gujrat, India due to significant GMP violations documente...
FDA chief of staff Julie Tierney says the agency is experiencing a larger-than-normal exodus of retiring employees now that the Covid-19 public health...
Abiomed recalls its Impella 5.5 with SmartAssist System after receiving complaints about purge fluid leaking from the devices purge sidearm.
FDA issues a Dear Doctor letter about supply constraints involving non-sterile, single-use pneumatic tourniquet cuffs in the U.S.
