Team-NB heads consortium to develop open-source, single-entry-point digital assessment framework to replace “onerous” ...

Roughly half of the FDA applications with September user fee goal dates involve pediatric populations, including four novel ...

The Bridge program may have enrolled 15% of eligible Part D beneficiaries after just two months, which raises questions about ...

Nov. 12 deadline for limiting all THC to 0.3% concentration and 0.4mg per-container limit along with ban on synthetics ...

Targeting patients with the TP53 Y220C mutation, thought to be present in about 3.2% of ovarian cancer cases, PMV says ...

The company still plans to file an NDA for envudeucitinib for psoriasis and said a prespecified analysis in the Phase IIb ...

September will see a busier medical meeting schedule with upcoming conferences including the ERS respiratory meeting, and ...

The UK medicines regulator has set its sights on making a global pharmacovigilance harmonization initiative more ...

Memorandum of understanding between the two agencies allows them to share non-public information in order to improve ...

Aurobindo has confirmed that its Lannett subsidiary has launched its US generic rival to Advair. But almost seven years since ...

Hear how emerging technologies and evolving regulatory thinking are helping sponsors navigate the complexities of ...

The FDA’s acceptance of Alvotech’s AVT80 application expands its US Entyvio biosimilar program into subcutaneous ...