In late April, the FDA notified SCYNEXIS that the clinical hold on ibrexafungerp had been lifted and concluded that the Phase 3 MARIO study could resume. The MARIO study is a Phase 3 trial evaluating ...

The announcement by President Donald Trump’s administration of the results of a probe into pharmaceutical imports and new sector-specific tariffs ...

Gain insights from Mersana Therapeutics' Q2 2025 earnings call. Highlights include Emi-Le advancements in TNBC, $15M milestone, and a $77M cash position.

Q2 2025 Earnings Call Transcript August 12, 2025 Spero Therapeutics, Inc. beats earnings expectations. Reported EPS is $-0.03 ...

GSK and CureVac will together receive $740 million, as well as royalties on sales of COVID-19 vaccines in the US ...

The GSK Flovent example highlights the consequences for patients and pharma of the decision to eliminate the Medicaid rebate cap.

British drugmaker GSK said on Monday that the U.S. Food and Drug Administration has accepted its application for priority ...

It is not clear whether Prasad will still serve as the agency’s chief medical and scientific officer, Stat reports. Meanwhile, Center for Drug Evaluation and Research staff grill top drug regulator ...

GSK plc's experimental antibiotic, gepotidacin, has been granted priority review by the U.S. Food and Drug Administration ...

This episode of Pharma Pulse explores the FDA’s new proactive quality review initiative for drug manufacturing, GSK’s $370 ...

Austin family advocates for getting fully vaccinated for meningococcal disease after daughter lost her legs and fingers as a ...