Blog
RSS FeedPosted by Michael Wonder on 31 Aug 2025
FDA approval of Leqembi subcutaneous formulation charts path to combination therapies for Alzheimer's disease
29 August 2025 - Subcutaneous delivery increases accessibility and introduces potential for at home administration, following model of diabetes and ...
Posted by Michael Wonder on 28 Jun 2022
Janssen receives positive CHMP opinion for Imbruvica (ibrutinib) in a fixed-duration combination regimen for adult patients with previously untreated chronic lymphocytic leukaemia
24 June 2022 - The positive opinion is based on Phase 3 GLOW and Phase 2 CAPTIVATE study results, which investigated ...
Posted by Michael Wonder on 28 Jun 2022
Kyowa Kirin receives positive CHMP opinion for use of Crysvita (burosumab) for the treatment of tumour-induced osteomalacia
24 June 2022 - Crysvita could offer access to the first biologic treatment for EU patients with tumour-induced osteomalacia who cannot ...
Posted by Michael Wonder on 28 Jun 2022
Gilead resubmits new drug application to U.S. FDA for lenacapavir, an investigational, long-acting HIV-1 capsid inhibitor
27 June 2022 - NDA Resubmission Addresses Issues Related to Vial Compatibility. ...
Posted by Michael Wonder on 28 Jun 2022
Innovent and Lilly jointly announce the approval of Tyvyt (sintilimab) by China NMPA in combination with chemotherapy as first-line treatment of advanced or metastatic gastric or gastro-oesophageal junction adenocarcinoma
26 June 2022 - Innovent Biologics and Eli Lilly announced that the NMPA of China has approved the supplemental new drug ...
Posted by Michael Wonder on 28 Jun 2022
Nexviadyme (avalglucosidase alfa) approved by European Commission as a potential new standard of care for the treatment of Pompe disease
28 June 2022 - Approved for the treatment of the full spectrum of both late-onset Pompe disease and infantile-onset Pompe disease. ...
Posted by Michael Wonder on 28 Jun 2022
Cosentyx (secukinumab) receives expanded approvals in EU for use in childhood arthritic conditions
27 June 2022 - Approvals based on data from the JUNIPERA trial, showing that Cosentyx® (secukinumab) reduced the risk of flare ...
Posted by Michael Wonder on 28 Jun 2022
Xenpozyme (olipudase alfa) approved by European Commission as first and only treatment for ASMD
28 June 2022 - The European Commission has approved Xenpozyme (olipudase alfa) as the first and only enzyme replacement therapy for ...
Posted by Michael Wonder on 28 Jun 2022
Fees and charges: summary from 1 July 2022
27 June 2022 - The TGA has updated its summary of fees and charges effective 1 July 2022. ...
Posted by Michael Wonder on 28 Jun 2022
Adverum Biotechnologies granted Priority Medicines (PRIME) designation by EMA for ADVM-022 in wet AMD
24 June 2022 - Adverum Biotechnologies today announced that the EMA has granted ADVM-022 Priority Medicines (PRIME) designation for the treatment ...
Posted by Michael Wonder on 28 Jun 2022
Curium announces the submission of its marketing authorisation application for [18F]-DCFPyL to the EMA
27 June 2022 - Submission follows the completion of Phase III PYTHON clinical trial of [18F]-DCFPyL for recurrent prostate cancer in ...
Posted by Michael Wonder on 27 Jun 2022
TLV receives assignments for medicines for rare diseases
27 June 2022 - The Government has commissioned the Swedish Dental and Pharmaceutical Benefits Agency (TLV) to analyse and make ...
Posted by Michael Wonder on 27 Jun 2022
Why won’t Congress do what Mark Cuban is doing for affordable drug prices?
27 June 2022 - You’ve probably heard of Mark Cuban, billionaire co-owner of the Dallas Mavericks, serial entrepreneur and investor, and ...
Posted by Michael Wonder on 27 Jun 2022
TLV receives a new assignment on precision medicine and ATMP
27 June 2022 - The Government has commissioned the Swedish Dental and Pharmaceutical Benefits Agency (TLV) to continue the work ...
Posted by Michael Wonder on 27 Jun 2022
FDA approves treatment for chronic weight management in certain paediatric patients aged 12 years and older
27 June 2022 - The U.S. FD has approved a supplemental indication for Qsymia (phentermine and topiramate extended-release capsules) for chronic ...
Posted by Michael Wonder on 27 Jun 2022
U.S. FDA declines to approve Spero's urinary tract infection drug
27 June 2022 - The U.S. FDA declined to approve Spero Therapeutics' oral antibiotic drug for the treatment of patients ...