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FDA’s complete response letter for subcutaneous Saphnelo highlights regulatory scrutiny around manufacturing and formulation changes in the industry.

The deal highlights how RNAi is moving into a more industrial phase of drug development, as large pharmaceutical companies look to pair advanced delivery technologies with the scale and durability

Angela Schwab, CEO at Trialynx, continues her conversation with Pharmaceutical Executive, this time detailing her experience with debuting her company at the conference.

In today’s Pharmaceutical Executive Daily, the FDA introduces a PreCheck pilot program aimed at strengthening domestic manufacturing oversight, an ACIP member alleges FDA leadership halted a decision related to COVID-19 vaccines, and Eli Lilly announces plans for a $3 billion manufacturing facility in Pennsylvania.

FDA PreCheck will provide benefits to manufacturing sites that fit criteria focused on benefiting the United States.

A public clash is emerging between ACIP advisers and the FDA over the future of Covid vaccines, as ACIP vice chair Robert Malone publicly accuses Commissioner Marty Makary of blocking efforts to remove the shots from the market.

The facility builds on Eli Lilly's $50 Billion investment strategy to strengthen the company's domestic manufacturing capabilities.

How to optimize a pharma location strategy in unheralded but rich regions for biotech talent around the world.

In today’s Pharmaceutical Executive Daily, Public Citizen files suit over undisclosed drug pricing agreements involving Pfizer and Eli Lilly, HHS releases new guidance aimed at lowering prescription drug costs through direct-to-consumer programs, and AstraZeneca enters a multibillion-dollar collaboration with CSPC Pharmaceutical Group.

The deal underscores a broader shift in autoimmune drug development toward therapies that aim to reprogram disease-driving immune responses at their source.

How demand-driven development will help new products be more successful.

DTP programs are redefining the manufacturer’s access operating model.

Teva’s VP of US innovative medicines marketing discusses the origins of the company’s new campaign featuring comedian Will Forte.