Blog
RSS FeedPosted by Michael Wonder on 03 Jun 2026
FDA approves more orphan drugs with specific cancer, paediatric indications over EMA
2 June 2026 - The US FDA is more likely to approve drugs with an orphan designation that were indicated ...
Posted by Michael Wonder on 27 May 2026
Outlook Therapeutics wins appeal following formal dispute resolution process for ONS-5010/Lytenava (bevacizumab-vikg) company plans to resubmit BLA to the FDA in June 2026
26 May 2026 - Outlook Therapeutics today announced that the US FDA has granted the appeal following completion of the ...
Posted by Michael Wonder on 25 May 2026
New medicine for two types of pulmonary fibrosis
22 May 2026 - Jascayd slowed loss of lung function in patients with idiopathic or progressive pulmonary fibrosis. ...
Posted by Michael Wonder on 20 May 2026
FDA official offers examples of RWE being used to secure drug approval
19 May 2026 - An official from the US FDA on Monday presented three case studies demonstrating how sponsors effectively ...
Posted by Michael Wonder on 12 May 2026
FDA advances drug repurposing to address unmet medical needs
11 May 2026 - Agency is particularly focused on new uses to treat chronic or rare diseases. ...
Posted by Michael Wonder on 03 May 2026
US pushes real time clinical trials to eliminate “dead time” in approvals
1 May 2026 - The US FDA is testing “real time clinical trials,” which it says will provide faster access ...
Posted by Michael Wonder on 01 May 2026
Johnson & Johnson to offer four prescription medicines on TrumpRx website
24 April 2026 - Johnson & Johnson will start selling four of its medications on the Trump administration's TrumpRx website, ...
Posted by Michael Wonder on 29 Apr 2026
FDA announces major steps to implement real time clinical trials
28 April 2026 - The US FDA today announced two major steps as part of an initiative to advance the implementation ...
Posted by Michael Wonder on 24 Apr 2026
EMA sees slight improvement in approval submission predictability, reversing trend
23 April 2026 - The trend for the timing of initial marketing authorisation applications to be less predictable is slowly reversing ...
Posted by Michael Wonder on 23 Apr 2026
Regeneron announces agreement with US Government to help lower drug costs for American patients and will provide innovative new gene therapy for free in the US
23 April 2026 - Regeneron Pharmaceuticals today announced an agreement with the US Government to help lower prices of several ...
Posted by Michael Wonder on 23 Apr 2026
CMS and FDA announce RAPID coverage pathway to accelerate patient access to life changing medical devices
23 April 2026 - New pathway cuts red tape and brings predictability to Medicare coverage for Breakthrough Devices. ...
Posted by Michael Wonder on 21 Apr 2026
20 years of priority review vouchers, a tool for spurring needed drugs
19 April 2026 - Occasionally I’ll go watch a TV show taping. Big-name shows are sold out, with long lines ...
Posted by Michael Wonder on 16 Apr 2026
ICER releases white paper on accelerated approval pathway for prescription drugs
16 April 2026 - The ICER, in collaboration with Verdant Research, has published a new white paper today that examines the ...
Posted by Michael Wonder on 08 Apr 2026
Access Consortium sets 2026 priorities to accelerate work-sharing and improve patient access to innovative medicines
7 April 2026 - The MHRA-led Access Consortium 2026 action plan will deepen collaboration, streamline work sharing, and speed up access ...
Posted by Michael Wonder on 04 Apr 2026
US hikes tariffs on Korean patented drugs, spares biosimilars for year
3 April 2026 - Korean drug makers eye US manufacturing labels and limited exemptions as Washington targets patented meds with new ...