Blog
RSS FeedPosted by Michael Wonder on 17 Jan 2026
Some drugmakers quietly concerned about legal risk with speedy FDA review program
16 January 2026 - More than half a dozen major drug makers are participating in the Trump Administration's speedier review ...
Posted by Michael Wonder on 17 Jan 2026
US FDA delays two drug reviews in new voucher program after safety, efficacy concerns
15 January 2026 - The US FDA has delayed reviews of two drugs chosen for the Trump Administration's new fast ...
Posted by Michael Wonder on 17 Jan 2026
Novartis ianalumab receives FDA breakthrough therapy designation for Sjögren’s disease
16 January 2026 - Novartis today announced that the US FDA has granted breakthrough therapy designation to ianalumab for Sjögren’s disease, ...
Posted by Michael Wonder on 16 Jan 2026
FDA reports lack of interest, high rejection rate for its STAR program
15 January 2026 - The US FDA said there is "minimal industry interest" from companies to participate in its Split ...
Posted by Michael Wonder on 16 Jan 2026
Guiding principles of good AI practice in drug development
14 January 2026 - The CDER and CBER have collaborated with the EMA to develop 10 guiding principles that industry ...
Posted by Michael Wonder on 16 Jan 2026
FDA issues guidance on modernising statistical methods for clinical trials
12 January 2026 - The US FDA today published draft guidance designed to facilitate the use of Bayesian methodologies in ...
Posted by Michael Wonder on 14 Jan 2026
Travere Therapeutics announces FDA extends review of sNDA for Filspari (sparsentan) in FSGS
13 January 2026 - Travere Therapeutics announced that today the US FDA has extended the review timeline of its supplemental new ...
Posted by Michael Wonder on 14 Jan 2026
Henlius' fifth US filing product bevacizumab biosimilar HLX04 receives FDA BLA acceptance
13 January 2026 - Shanghai Henlius Biotech announced that the biologics license application for HLX04, the Company’s independently developed bevacizumab biosimilar ...
Posted by Michael Wonder on 14 Jan 2026
argenx announces FDA acceptance of supplemental biologics license application with priority review for Vyvgart in AChR-Ab seronegative gMG
13 January 2026 - argenx today announced that the US FDA has accepted for priority review a supplemental biologics license application ...
Posted by Michael Wonder on 14 Jan 2026
US FDA grants Ipsen’s IPN60340 (ICT01) breakthrough therapy designation in first line unfit acute myeloid leukaemia
13 January 2025 - Ipsen announced today that the US FDA has granted breakthrough therapy designation for IPN60340 in combination with ...
Posted by Michael Wonder on 13 Jan 2026
Summit Therapeutics announces submission of biologics license application to US FDA seeking approval for ivonescimab in combination with chemotherapy in second-line (or later) treatment of patients with EGFRm NSCLC
12 January 2026 - Summit Therapeutics today announced that it has submitted a biologics license application to the US FDA seeking ...
Posted by Michael Wonder on 13 Jan 2026
Sebela Pharmaceuticals announces submission of new drug application to FDA for tegoprazan for the treatment of gastro-oesophageal reflux disease
12 January 2026 - Braintree Laboratories, a part of Sebela Pharmaceuticals, announced that it submitted a new drug application on 9 ...
Posted by Michael Wonder on 12 Jan 2026
Encoded Therapeutics announces US FDA breakthrough therapy designation granted to ETX101 for the treatment of Dravet syndrome
12 January 2026 - Encoded Therapeutics today announced that the US FDA has granted breakthrough therapy designation to ETX101 for the ...
Posted by Michael Wonder on 12 Jan 2026
FDA accepts new drug application for pimicotinib for the treatment of tenosynovial giant cell tumoir
12 January 2026 - Merck announced today that the US FDA has accepted the company’s new drug application for pimicotinib as ...
Posted by Michael Wonder on 12 Jan 2026
FDA approves first treatment for children with Menkes disease
12 January 2026 - The US FDA today approved the Zycubo (copper histidinate) injection as the first treatment for Menkes disease ...