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RSS FeedPosted by Michael Wonder on 31 Jul 2026
Johnson & Johnson’s Rybrevant Faspro (amivantamab and hyaluronidase-lpuj) receives US FDA priority review as potential first-in-class EGFR- and MET-targeted subcutaneous treatment for advanced head and neck cancer
30 July 2026 - Johnson & Johnson today announced that the US FDA has granted priority review to the supplemental biologics ...
Posted by Michael Wonder on 30 Jul 2026
PolyPid announces FDA acceptance of NDA with priority review for D-PLEX₁₀₀
29 July 2026 - PolyPid today announced that the US FDA has accepted for filing the new drug application and granted ...
Posted by Michael Wonder on 29 Jul 2026
Nidlegy marketing authorisation application resubmitted to EMA
27 July 2026 - Philogen is pleased to announce the submission of an updated marketing authorisation application to the EMA ...
Posted by Michael Wonder on 29 Jul 2026
Saol Therapeutics announces the acceptance of resubmission of SL1009 by the FDA with PDUFA Date of 30 December 2026
28 July 2026 - Saol Therapeutics today announced that the US FDA has acknowledged the company's resubmission of its new ...
Posted by Michael Wonder on 26 Jul 2026
Celltrion files for European approval of Cosentyx biosimilar CT-P55, accelerating push into key global markets
24 July 2026 - Celltrion said Friday it has submitted a marketing authorization application to the EMA for CT-P55, its ...
Posted by Michael Wonder on 26 Jul 2026
Revolution Medicines’ new drug application for daraxonrasib accepted for review by US FDA for previously treated metastatic pancreatic cancer
22 July 2026 - Revolution Medicines today announced that the US FDA accepted for review the company’s new drug application for ...
Posted by Michael Wonder on 23 Jul 2026
FDA grants priority review for Pfizer’s Talzenna plus Xtandi for the treatment of metastatic prostate cancer
22 July 2026 - Pfizer today announced that the US FDA accepted for priority review a supplemental new drug application ...
Posted by Michael Wonder on 22 Jul 2026
Marketing authorisation application for in-house developed insomnia drug lemborexant accepted for evaluation by EMA
16 July 2026 - Eisai announced today that the EMA has accepted for evaluation a marketing authorization application for its ...
Posted by Michael Wonder on 21 Jul 2026
Axsome Therapeutics announces FDA acceptance of new drug application for AXS-12 for the treatment of cataplexy in narcolepsy
15 July 2026 - Axsome Therapeutics today announced that the US FDA has accepted for filing the Company’s new drug application ...
Posted by Michael Wonder on 21 Jul 2026
Dyne Therapeutics announces US FDA acceptance of biologics license application for z-rostudirsen in exon 51 Duchenne muscular dystrophy
20 July 2026 - Dyne Therapeutics today announced that the US FDA has accepted for review the biologics license application ...
Posted by Michael Wonder on 21 Jul 2026
Almirall announces EMA acceptance for filing of paediatric registration of Ebglyss (lebrikizumab) in atopic dermatitis in children 6 months and older
20 July 2026 - The EMA application is supported by data from the paediatric clinical programme for lebrikizumab, including the pivotal ...
Posted by Michael Wonder on 21 Jul 2026
EMA accepts submission to update Bexsero label for 1 dose meningitis B booster in 10+ year olds
20 July 2026 - GSK today announced the EMA has accepted a submission to update the label for Bexsero to ...
Posted by Michael Wonder on 19 Jul 2026
US FDA accepts Bristol Myers Squibb's new drug application for mezigdomide in patients with relapsed or refractory multiple myeloma
13 July 2026 - Bristol Myers Squibb today announced that the US FDA has accepted a new drug application for ...
Posted by Michael Wonder on 19 Jul 2026
US FDA accepts BioMarin’s supplemental new drug application for full approval of Voxzogo (vosoritide) for children with achondroplasia
13 July 2026 - BioMarin today announced that the US FDA has accepted the company's supplemental new drug application for Voxzogo ...
Posted by Michael Wonder on 18 Jul 2026
FDA accepts Shionogi’s sNDA for Fetroja (cefiderocol) for use in pediatric patients with serious infections caused by susceptible gram negative bacteria submission intends to address a critical therapeutic gap for vulnerable young patients facing drug-resistant pathogens
17 July 2026 - Shionogi announced the US FDA has accepted a supplemental new drug application for Fetroja (cefiderocol) for ...