MLive1h
7,100 bottles of antidepressant recalled by FDA now in 2nd highest risk class
Duloxetine Delayed-Release Capsules were recalled because the pills may contain high levels of a cancer-causing chemical.
Antidepressant recalled: 2nd-highest FDA risk level; drug contains cancerous chemical
The U.S. Food and Drug Administration updated the risk level of a recalled antidepressant due to the product containing high ...
US FDA declines to approve Camurus' rare hormone disorder drug
The U.S. Food and Drug Administration has declined to approve Camurus' drug for the treatment of a rare hormonal disorder due ...
FierceBiotech56m
Sangamo slashes time to market for Fabry gene therapy as FDA agrees to accelerated approval package
The biotech engaged with the FDA on alternative pathways to approval after seeing safety and efficacy data from the phase 1/2 ...
FiercePharma3h
FDA stymies Camurus' hormonal disorder drug due to 3rd-party manufacturing issues
The FDA issued a complete response letter (CRL) to Camurus, dealing a setback to the Swedish drugmaker’s efforts to bring its ...
Targeted Oncology49m
FDA Clears IND of ADRX-0405, Next-Gen ADC, in Solid Tumors
ADRX-0405 is a novel antibody-drug conjugate targeting STEAP1, and a phase 1a/b study will investigate the agent for the ...
BioSpace4h
FDA Rejects Camurus’ Rare Hormonal Disorder Treatment Due to Manufacturing Problems
The regulator cited deficiencies at a third-party manufacturing facility. Camurus is seeking approval for its ...
Antidepressant recall: FDA upgrades medication risk class to 2nd highest level in recall update
The U.S. Food and Drug Administration is urging patients not to stop taking their prescribed medication if it falls under the ...
FierceBiotech3h
FDA grants de novo clearance to airway stent covered with human tissue
The FDA has granted a de novo clearance to a new type of stent designed to hold open the passages down the windpipe and into ...
ENDPOINTS NEWS6h
FDA hits Ca­mu­rus with CRL for acromegaly ther­a­py over man­u­fac­tur­ing is­sues
The FDA handed a CRL to the Swedish biotech Camurus for its hormone disorder therapy over “facility-related deficiencies” at ...
STAT1d
Former FDA lawyers join tobacco industry in ‘epic’ fight against the agency
Gorji joined DLA Piper, one of the biggest law firms in the world, as a litigation partner, adding to its FDA team, which ...
MassDevice2h
Peytant wins FDA de novo nod for covered stent system
Peytant Solutions announced today that the FDA granted marketing authorization for its AMStent tracheobronchial covered stent ...