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RSS FeedPosted by Michael Wonder on 27 Nov 2025
US FDA grants priority review to sonrotoclax for the treatment of relapsed or refractory mantle cell lymphoma
26 November 2025 - BeOne Medicines today announced that the US FDA has accepted and granted priority review to a ...
Posted by Michael Wonder on 26 Nov 2025
Novo Nordisk files for FDA approval of a higher dose of Wegovy injection 7.2 mg
26 November 2025 - Today, Novo Nordisk announced the submission of an supplemental new drug application to the US FDA ...
Posted by Michael Wonder on 26 Nov 2025
Ascendis announces extension of FDA review period for TransCon CNP (navepegritide) for children with achondroplasia
25 November 2025 - PDUFA goal date extended by three months to 28 February 2026. ...
Posted by Michael Wonder on 26 Nov 2025
Otsuka Pharmaceutical submits new drug application to US FDA for centanafadine for the treatment of ADHD in children, adolescents, and adults
24 November 2025 - Otsuka today announce the filing of a new drug application with the US FDA for centanafadine, once ...
Posted by Michael Wonder on 26 Nov 2025
Eisai completes rolling submission to US FDA for Leqembi Iqlik (lecanemab-irmb) supplemental biologics license pplication as a subcutaneous starting dose for the treatment of early Alzheimer's disease under fast track status
25 November 2025 - Eisai and Biogen announced today that Eisai has completed the rolling submission of the supplemental biologics ...
Posted by Michael Wonder on 21 Nov 2025
Sangamo Therapeutics announces FDA acceptance of BLA rolling submission request for ST-920 in Fabry disease
21 November 2025 - Sangamo Therapeutics today announced that the US FDA has accepted Sangamo’s request for a rolling submission and ...
Posted by Michael Wonder on 21 Nov 2025
Taiho Oncology, Taiho Pharmaceutical and Cullinan Therapeutics initiate rolling submission of new drug application to US FDA for zipalertinib for treatment of locally advanced or metastatic non-small cell lung cancer with EGFR exon 20 insertion mutations
20 November 2025 - Taiho Oncology, Taiho Pharmaceutical and Cullinan Therapeutics today announced the companies have initiated the rolling submission ...
Posted by Michael Wonder on 20 Nov 2025
Nuvalent announces FDA acceptance of new drug application for zidesamtinib for the treatment of TKI pre-treated patients with advanced ROS1 positive NSCLC
19 November 2025 - Nuvalent today announced the US FDA has accepted for filing its new drug application for zidesamtinib, ...
Posted by Michael Wonder on 19 Nov 2025
FDA grants traditional approval to tarlatamab-dlle for extensive stage small cell lung cancer
19 November 2025 - Today, the FDA granted traditional approval to tarlatamab-dlle (Imdelltra, Amgen Inc.) for adults with extensive stage ...
Posted by Michael Wonder on 17 Nov 2025
Celcuity announces completion of submission of its new drug application to the US FDA for gedatolisib in HR+/HER2-/PIK3CA wild type advanced breast cancer
17 November 2025 - Celcuity today announced the completion of the submission of its new drug application to the US FDA ...
Posted by Michael Wonder on 16 Nov 2025
Ascelia Pharma announces FDA acceptance of Orviglance new drug application for review
15 November 2025 - Ascelia Pharma today announced that the US FDA has accepted the new drug application for Orviglance for ...
Posted by Michael Wonder on 14 Nov 2025
Outlook Therapeutics announces acceptance of biologics license application by FDA for ONS-5010 as a treatment for wet AMD
13 November 2025 - Outlook Therapeutics today announced that the US FDA has acknowledged receipt of the resubmission of the ...
Posted by Michael Wonder on 14 Nov 2025
ITM announces FDA acceptance of new drug application and PDUFA date for lutetium Lu 177 edotreotide (ITM-11) in gastro-enteropancreatic neuroendocrine tumours
13 November 2025 - 2025 - ITM Isotope Technologies today announced that the US FDA completed its filing review and accepted ...
Posted by Michael Wonder on 08 Nov 2025
FDA awards second batch of national priority vouchers
6 November 2025 - The US FDA today announced six additional awardees under the Commissioner’s National Priority Voucher pilot program. ...
Posted by Michael Wonder on 08 Nov 2025
Vera Therapeutics submits biologics license application to US FDA through accelerated approval program for atacicept for the treatment of adults with IgA nephropathy
7 November 2025 - Vera Therapeutics today announced it has submitted a biologics license application to the US FDA through ...