FDA Approvals

With two significant FDA clearances in as many weeks, Enhertu from AstraZeneca and Daiichi Sankyo is blazing. On August 11th,...

Although Pfizer beat Merck to sell its next-generation pneumococcal vaccination, it lost a more important battle in June when the...

The pharmaceutical lobbying group's aura of invincibility has faded. The U.S. Senate recently passed a new bill, leaving the pharmaceutical...

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

Could the Senate adopt a "watershed" bill allowing drug price discussions after years of government inaction regarding medication prices in the...

Pfizer previously held out hope that Eucrisa would become the trendiest topical treatment for inflammatory skin conditions. However, the ointment...

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

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

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