FDA Approvals

AstraZeneca (AZN.L) and Daiichi Sankyo (4568.T) on Friday secured U.S. approval that broadens the use of their therapy Enhertu, for patients with breast cancer, and paves the way...

Beovu, Made By Novartis, Earns A Recommendation From NICE

FDA Approvals

Following NICE's recommendation of a novel therapy alternative for diabetic macular oedema (DMO), thousands of patients could receive transformative care. In the final form...

Lilly, AZ, AbbVie, And J&J Could Be Hurt By Medicare Bill

FDA Approvals

Could the Senate adopt a "watershed" bill allowing drug price discussions after years of government inaction regarding medication prices in the U.S.? Analysts are busy...

Arcutis Receives FDA Nod For Their Zoryve Psoriasis Cream

FDA Approvals

Pfizer previously held out hope that Eucrisa would become the trendiest topical treatment for inflammatory skin conditions. However, the ointment never took off because...

FDA Continues To Deal With Issues With Expedited Clearance

FDA Approvals

The use of excessively fragile efficacy data and delays in sponsors' presenting living proof from post-approval trials, as well as the approval of some...

FDA Scrutinises 2 Cancer Permits Sans Voluntary Withdrawals

FDA Approvals

The oncology division of the FDA has recently tightened regulations for expedited approvals and emphasised the significance of patient survival data. Several businesses promptly...

Azurity Gets FDA Nod On Liquid Epilepsy Drug After Rejection

FDA Approvals

On the second attempt, Azurity Pharmaceuticals was able to secure an FDA nod for its zonisamide oral suspension, making it the first firm to do...

Subscribe Our Newsletter

White Papers

Whitepapers

FDA Approvals

About us

System

Resources

Subscribe