All articles by Manish Kumar
Manish Kumar
Eton announces commercial launch of Galzin (zinc acetate) capsules
Eton expects to significantly expand patient access to this critical treatment for Wilson disease patients
Fapon Biopharma announces FDA approval of IND for FP008
FP008 is a novel anti-PD-1×IL-10M fusion protein with a unique mechanism of action (MOA) and therapeutic potential for anti-PD-1 naïve or resistant patients
FDA grants priority review to Sobi’s sBLA for Gamifant in HLH/MAS
The sBLA is based on data from two studies showing a 53% complete response at week 8 and 85% at any time, involving 39 patients
Mustang Bio exits manufacturing lease and divests assets
Mustang Bio will save $2m over 24 months by terminating its lease, while relying on academic partners and future contract manufacturing for clinical trials
Woolsey completes B round extension to advance its ALS programme
Woolsey also has Orphan Drug Designations for the use of BRAVYL in ALS for both the U.S. and Europe
Lilly to invest $27bn in four new plants to boost domestic production
The investment boosts US capital expansion to over $50bn since 2020, amid potential drug import duties from the Trump administration
CSL receives Swissmedic approval for Andembry in HAE treatment
Andembry secures fifth regulatory approval in 2025, following authorisations from the TGA, MHRA, EC, and MHLW for HAE treatment
Fosun Pharma received NMPA approval for Wan Ti Le
Bringing New Hope to Chinese Dialysis Patients with Hyperphosphatemia
RedHill licenses RHB-102 to Hyloris for global markets in up to $60m deal
Hyloris gains exclusive rights to RHB-102 outside North America, while RedHill continues development for FDA approval in the US
Kashiv BioSciences receives Health Canada approval for Pegfilgrastim biosimilar injection
The approval was based on a regulatory evaluation, confirming that the injection meets quality, safety, and efficacy standards comparable to the reference biologic