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RSS FeedPosted by Michael Wonder on 11 Dec 2024
Krystal Biotech provides update on EMA’s on-going regulatory review of B-VEC for dystrophic epidermolysis bullosa
9 December 2024 - CHMP opinion now expected in Q1, 2025. ...
Posted by Michael Wonder on 10 Dec 2024
EMA publishes agenda for 9-12 December 2024 CHMP meeting
9 December 2024 - The EMA has published a draft agenda for this week's CHMP meeting. ...
Posted by Michael Wonder on 10 Dec 2024
MeiraGTx granted FDA regenerative medicine advanced therapy designation for AAV2-hAQP1 for the treatment of grade 2/3 radiation-induced xerostomia
9 December 2024 - MeiraGTx today announced that the US FDA has granted regenerative medicine advanced therapy designation to AAV2-hAQP1 for ...
Posted by Michael Wonder on 10 Dec 2024
FDA grants breakthrough therapy designation to Seres Therapeutics’ SER-155 for reduction of bloodstream infections in adults undergoing allogeneic haematopoietic stem cell transplantation
9 December 2024 - Designation based on encouraging Phase 1b clinical data, including that SER-155 resulted in a 77% relative risk ...
Posted by Michael Wonder on 10 Dec 2024
Datopotamab deruxtecan granted breakthrough therapy designation in US for patients with previously treated advanced EGFR mutated non-small cell lung cancer
9 December 2024 - First breakthrough therapy designation for Daiichi Sankyo and AstraZeneca’s datopotamab deruxtecan based on TROPION-Lung05 Phase 2 ...
Posted by Michael Wonder on 10 Dec 2024
Chiesi Global Rare Diseases and Protalix BioTherapeutics announce validation of variation submission by EMA for pegunigalsidase alfa
9 December 2024 - Application to label a less frequent dosing regimen at a dose of 2 mg/kg body weight ...
Posted by Michael Wonder on 10 Dec 2024
US FDA accepts GSK’s submission for the use of Nucala (mepolizumab) in COPD
9 December 2024 - Submission supported by MATINEE data showing significant and clinically meaningful reduction in annualised rate of moderate/severe exacerbations ...
Posted by Michael Wonder on 08 Dec 2024
Autopsy of a drug withdrawal — the case of melphalan flufenamide
7 December 2024 - The accelerated approval pathway, which was established in 1992, has expedited approvals of drugs for serious and ...
Posted by Michael Wonder on 07 Dec 2024
FDA accepts supplemental biologics license application for Roche’s Columvi combination for people with relapsed or refractory diffuse large B-cell lymphoma
5 December 2024 - Application is based on data from the Phase 3 STARGLO study where Columvi plus chemotherapy showed a ...
Posted by Michael Wonder on 07 Dec 2024
Imfinzi granted priority review in the US for patients with muscle-invasive bladder cancer
6 December 2024 - Decision based on NIAGARA Phase 3 trial results which demonstrated a statistically significant and clinically meaningful ...
Posted by Michael Wonder on 07 Dec 2024
FDA approves durvalumab for limited-stage small cell lung cancer
4 December 2024 - Today, the FDA approved durvalumab (Imfinzi, AstraZeneca) for adults with limited-stage small cell lung cancer whose ...
Posted by Michael Wonder on 07 Dec 2024
FDA grants accelerated approval to zenocutuzumab-zbco for non-small cell lung cancer and pancreatic adenocarcinoma
4 December 2024 - This represents the first FDA approval of a systemic therapy for patients with non-small cell lung cancer ...
Posted by Michael Wonder on 07 Dec 2024
Veozah (fezolinetant film coated tablets) receives Health Canada approval as first and only non-hormonal treatment for vasomotor symptoms associated with menopause
3 December 2024 - New treatment option helps fill unmet need for women experiencing hot flashes and night sweats associated ...
Posted by Michael Wonder on 07 Dec 2024
PIF Partners granted FDA rare paediatric disease designation for its proprietary small molecule in treating systemic juvenile idiopathic arthritis flares
3 December 2024 - PIF Partners announced today that the US FDA has granted rare paediatric disease designation to its proprietary ...
Posted by Michael Wonder on 07 Dec 2024
Saol Therapeutics announces submission of new drug application to the US FDA for SL1009
3 December 2024 - Saol Therapeutics today announced the submission of a new drug application to the US FDA for approval ...