News

Green Queen15h

Believer Meats Earns FDA Approval & Completes World’s Largest Factory for Cultivated Meat

Israeli food tech firm Believer Meats has secured US FDA approval for its cultivated meat, and completed the construction of ...
Medical Marketing & Media4h

FDA’s new national priority voucher program wants to speed up drug approvals while lowering drug costs

The FDA recently unveiled a new national priority voucher program that would seek to trade faster drug approvals for lower ...
PharmTech9h

CMC and Analytical Gaps in CRLs: Why They Persist Despite FDA Guidance and How You Can Position Yourself for Success

Many companies face FDA complete response letters due to ongoing chemistry, manufacturing, and controls, or CMC, and ...
KVIA13h

New medications coming soon: Here’s what’s been FDA approved in 2025 so far

GoodRx reports that in 2025, novel drug and biosimilar approvals lag slightly behind last year, while first generic approvals ...
PharmExec7h

Replimune CRL Fallout: How Biopharma Leaders Should Manage a New Layer of FDA Uncertainty

A deep dive into the implications of the Replimune CRL that surprised insiders and investors, the role of new leadership at ...

Houston-based Empower Pharmacy’s drugs raised red flags for FDA and other states, but not Texas

Empower Pharmacy, a Houston-based compounding pharmacy, has been sanctioned by the FDA and other states in the past decade.
Medscape7h

Can Medicare Afford the Perpetual Human?

As life-extending technologies and aging interventions proliferate, questions surround who will be granted access to a longer ...
Green Queen8h

Confidential by Default? The Transparency Dilemma in Europe’s Novel Foods System

Regulatory consultant’Rourke argues why the EU's current novel food regulation is slow, and what it can learn from ...