FDA approved Tecvayli (teclistamab-cqyv), a Johnson & Johnson drug developed for the treatment of adults with relapsed or refractory multiple myeloma (RRMM) who have received at least one of line of ...

The agency pointed to what it sees as a contradictory signal within uniQure's own dataset. Sham-controlled data from a small cohort of U.S. patients showed no treatment effect at 12 months, a finding ...

In 2004, FDA released its first botanical drug guidance to the industry. This was the first time that complex botanical drugs would be allowed through FDA’s process for pharmaceutical approval. That ...

Market access strategies are evolving as more biopharma companies commercialize their own therapies, requiring closer alignment with payer requirements, provider education, specialty pharmacy networks ...

Series C proceeds position Spectris for pivotal top-line data, regulatory submission, and launch planning ahead of a targeted ...

Employer Connect aggregates diverse administrators, from basic benefits management to comprehensive obesity programs with wraparound services, enabling employers to tailor coverage models to workforce ...

In today’s Pharmaceutical Executive Daily, Cognito Therapeutics and Nexcure secure new financing rounds to advance their pipelines, artificial intelligence and large language models reshape ...

Under the four-year agreement, Blackstone Life Sciences will provide Teva with $400 million to fund ongoing and future ...

While regulatory alignment remains essential, operational urgency driving companies to AI adoption is equally profound. In ...

Three imperatives now face leaders seeking success in 2026. They must navigate the global policy reset, future-proof go-to-market strategies, and innovate to meet modern realities and demands.

In this Pharmaceutical Executive Academy discussion, Najat Khan, PhD, CEO of Recursion Pharmaceuticals and former chief data ...

Assumption-based tactics erode trust and can trigger both unsubscribes and regulatory scrutiny. Instead, consent signals should act as green lights for personalization and red lights when boundaries ...