news
US and EU enter Mutual Recognition Agreement for drug manufacturing inspections
The FDA and EMA have agreed to rely on each other’s assessment of pharmaceutical manufacturing sites to reduce duplicative work.
List view / Grid view
Food and Drug Administration (FDA)
news
FDA grants Fast Track Designation to Parkinson’s therapy
PR001 has received Fast Track Designation from the regulatory body for the treatment of Parkinson’s disease.
news
FDA releases guidance on pharmaceutical product labelling
New guidance drafts have been announced by the FDA to improve patients understanding and keep information consistent.
news
Trump administration sees FDA enforcement actions decline
A study has shown the warning letters the FDA distributes have decreased by a third since Trump came to office.
news
FDA approves treatment for rare neurological disorder
An injection to treat NMOSD has been given approval by the FDA and has received orphan drug designation.
news
New partnership established to track drugs using blockchain
Walmart has joined a consortium that’s attempting to build a blockchain for tracking pharmaceutical supply chains.
news
Heart drugs free from carcinogens identified as recalls drag on
The Food and Drug Administration has released a list of 40 drugs used to treat hypertension and heart failure that don’t contain any known carcinogens...
news
Acting FDA Commissioner named
As Dr Scott Gottlieb steps down from his role next month, Dr Ned Sharpless has been announced as his short-term replacement...
news
New generic valsartan approved to address shortages
The FDA has prioritised the review of this drug application after multiple recalls of generic valsartan products from several manufacturers...
news
FDA commissioner Scott Gottlieb resigns
Scott Gottlieb has announced that he will resign from the position of commissioner of the US Food and Drug Administration (FDA) at the end of the month...
news
FDA finds another carcinogenic impurity in ARB blood pressure drug
FDA is 'deeply concerned' about a third type of nitrosamine impurity detected in angiotensin II receptor blocker (ARB) medicines...
news
FDA launches pilot programme to track and trace US supply chain
The pilot project will test innovative and emerging approaches for enhanced tracing and verification of prescription drugs in the US...
news
Cancer drug with accelerated approval fails Phase III trial
Results did not confirm the clinical benefit of Lartruvo in combination with doxorubicin compared to doxorubicin alone…
news
Generic version of seizure drug Sabril gets FDA approval
A generic version of the seizure drug Sabril (vigabatrin) has been approved by the FDA...
news
Inhaled dry powder formulation of treprostinil works well in PAH patients
A formulation of treprostinil as an inhaled dry powder has proven to be safe and effective, as reported in the safety analysis of a Phase III trial...
