regulatory

Patients

Medicines access concept, life sciences symbols on aqua background

Approval is not access: Pilots’ real test is implementation

A medicine can be nationally recommended and still be difficult to access if local systems are not ready to identify, offer, deliver, and monitor it.

News

Pfizer, Valneva Lyme vaccine starts review in Europe

After reporting mixed clinical results in a phase 3 trial, Pfizer and Valneva have filed their Lyme disease vaccine candidate PF-07307405 in the EU.

News

Manufacturing issues mar ITM's radiopharma filing, says FDA

ITM's first attempt to score FDA approval for one of its radiopharma therapies has been knocked back by the agency.

Market Access

Three separate injections - blue, red, and yellow - take off against black background

Why global pharmaceutical reforms are quietly redirecting ra...

Publication of the 2026 Pharma Package by the Council of the EU represents the most significant reform of EU pharmaceutical legislation in over 20 yrs

R&D

ESG considerations digitally overlain on green cityscape background

Integrate or isolate: Incorporating traditional safety-relat...

Should traditional safety considerations be treated as distinct from broader ESG frameworks, or fully integrated within them?

News

Adcomm backs Replimune melanoma drug, despite data concern

Replimune's RP1 immunotherapy for melanoma clears advisory committee vote by 10 to three, despite FDA concerns about the design of the IGNYTE study.

Approval is not access: Pilots’ real test is implementation

Pfizer, Valneva Lyme vaccine starts review in Europe

Manufacturing issues mar ITM's radiopharma filing, says FDA

Why global pharmaceutical reforms are quietly redirecting ra...

Integrate or isolate: Incorporating traditional safety-relat...

Adcomm backs Replimune melanoma drug, despite data concern

ESC26: Isomab safety evidence on blood vessel growth for CAD

Discover a new era of healthcare panel engagement: Grounded ...

regulatory

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