Blog
RSS FeedPosted by Michael Wonder on 21 Mar 2025
Alnylam announces FDA approval of Amvuttra (vutrisiran), the first RNAi therapeutic to reduce cardiovascular death, hospitalisations and urgent heart failure visits in adults with ATTR amyloidosis with cardiomyopathy
20 March 2025 - Only therapeutic approved in the US to address both cardiomyopathy and polyneuropathy manifestations of ATTR amyloidosis. ...
Posted by Michael Wonder on 21 Mar 2025
US FDA approves Tremfya (guselkumab), the first and only IL-23 inhibitor offering both subcutaneous and intravenous induction options, for adult patients with moderately to severely active Crohn’s disease
20 March 2025 - Supported by data from the GALAXI study, Tremfya is the only IL-23 inhibitor to show superiority versus ...
Posted by Michael Wonder on 21 Mar 2025
Secretome Therapeutics granted FDA fast track designation for STM-01, a neonatal cardiac progenitor cell therapy for HFpEF
20 March 2025 - Secretome Therapeutics today announced that the US FDA has granted fast track designation to STM-01, the company’s ...
Posted by Michael Wonder on 20 Mar 2025
FDA approves pembrolizumab for HER2 positive gastric or gastro-oesophageal junction adenocarcinoma expressing PD-L1
19 March 2025 - Today, the FDA granted traditional approval to pembrolizumab (Keytruda, Merck) with trastuzumab, fluoropyrimidine- and platinum-containing chemotherapy ...
Posted by Michael Wonder on 20 Mar 2025
Azercabtagene zapreleucel granted FDA fast track designation in blood cancer DLBCL
19 March 2025 - Imugene is pleased to announce that the US FDA has granted fast track designation to its ...
Posted by Michael Wonder on 20 Mar 2025
Travere Therapeutics submits sNDA to FDA for approval of Filspari (sparsentan) for the treatment of focal segmental glomerulosclerosis
17 March 2025 - sNDA submission based on results from Phase 3 DUPLEX and Phase 2 DUET studies of Filspari in focal ...
Posted by Michael Wonder on 20 Mar 2025
Alvotech and Dr. Reddy’s announce FDA acceptance of biologic license application for AVT03, a proposed biosimilar to Prolia and Xgeva
18 March 2025 - Dr. Reddy’s Laboratories and Alvotech today announced that the US FDA has accepted a 351(k) biologic license ...
Posted by Michael Wonder on 19 Mar 2025
Scienture announces the US FDA approval of its NDA for SCN-102 to be launched as Arbli (losartan potassium) 10 mg/mL oral suspension
18 March 2025 - Scienture is pleased to announce the US FDA has approved SCN-102 with the brand name Arbli (losartan ...
Posted by Michael Wonder on 19 Mar 2025
Nipocalimab, the first and only investigational treatment to be granted US FDA breakthrough therapy designation for the treatment of adults with moderate to severe Sjögren’s disease, has now received fast track designation
18 March 2025 - This marks the fourth nipocalimab FDA fast track designation. ...
Posted by Michael Wonder on 19 Mar 2025
US FDA grants priority review for new indication of finerenone for patients with common form of heart failure
17 March 2025 - Regulatory submission is based on positive results from the Phase 3 FINEARTS-HF study, which is part of ...
Posted by Michael Wonder on 18 Mar 2025
Cellphire Therapeutics CLPH-511 fast track designation granted
17 March 2025 - Cellphire Therapeutics today announced that the US FDA has granted fast track designation for CLPH-511 (frozen activated ...
Posted by Michael Wonder on 17 Mar 2025
ANI Pharmaceuticals announces FDA approval for expansion of Iluvien label
14 March 2025 - ANI plans to begin marketing Iluvien in the US under the combined label later this year. ...
Posted by Michael Wonder on 14 Mar 2025
ANI Pharmaceuticals announces FDA approval of new purified Cortrophin Gel pre-filled syringe
3 March 2025 - ANI Pharmaceuticals today announced US FDA approval of purified Cortrophin Gel (repository corticotropin injection USP) (Cortrophin Gel) ...
Posted by Michael Wonder on 13 Mar 2025
Seikagaku announces receipt of a complete response letter concerning the biologics license application in the US for SI-6603 (condoliase)
12 March 2025 - Seikagaku announced today that it has received from the US FDA a complete response letter concerning ...
Posted by Michael Wonder on 12 Mar 2025
Atsena Therapeutics granted US FDA fast track designation for ATSN-201 gene therapy to treat X-linked retinoschisis
12 March 2025 - Marks third FDA designation for ATSN-201, which has also received rare paediatric disease designation and orphan drug ...