Blog
RSS FeedPosted by Michael Wonder on 06 Feb 2025
Bayer files for approval of finerenone in heart failure in the EU
3 February 2025 - Regulatory submission is based on positive data from the Phase 3 FINEARTS-HF study presented at ESC Congress ...
Posted by Michael Wonder on 29 May 2025
Pfizer and BioNTech submit EMA application for COVID-19 vaccine targeting LP.8.1 for 2025-2026 season
28 May 2025 - 2025 -- Pfizer and BioNTech today announced that they have submitted a regulatory application to the ...
Posted by Michael Wonder on 29 May 2025
Alcon announces FDA approval of Tryptyr (acoltremon ophthalmic solution) 0.003% for the treatment of the signs and symptoms of dry eye disease
28 May 2025 - Tryptyr is a first in class TRPM8 receptor agonist that rapidly stimulates natural tear production in patients ...
Posted by Michael Wonder on 28 May 2025
Experimental Drug Development Centre granted US FDA fast track designation for antibody-drug conjugate EBC-129 to treat pancreatic ductal adenocarcinoma
28 May 2025 - EBC-129 is the first made in Singapore antibody-drug conjugate to enter clinical development. ...
Posted by Michael Wonder on 28 May 2025
Candel Therapeutics receives FDA regenerative medicine advanced therapy designation for CAN-2409 for the treatment of prostate cancer
28 May 2025 - Candel Therapeutics today announced that the US FDA has granted regenerative medicine advanced therapy designation to CAN-2409 ...
Posted by Michael Wonder on 28 May 2025
US FDA accepts new drug application under priority review for sevabertinib (BAY 2927088) in HER2 mutant non-small cell lung cancer
28 May 2025 - Regulatory submission is based on positive results from the on-going Phase I/II SOHO-01 trial in patients with ...
Posted by Michael Wonder on 28 May 2025
Bristol Myers Squibb receives European Commission approval for the subcutaneous formulation of Opdivo (nivolumab) across multiple solid tumour indications
28 May 2025 - Approval is based on results from the Phase 3 CheckMate -67T clinical trial which demonstrated non-inferiority in ...
Posted by Michael Wonder on 28 May 2025
Fresenius Kabi to announce the commercial launch of Otulfi, an approved ustekinumab biosimilar in Canada
27 May 2025 - Fresenius Kabi's ustekinumab biosimilar Otulfi is now commercially available for both subcutaneous and intravenous formulations. ...
Posted by Michael Wonder on 28 May 2025
New subcutaneous formulation of Opdivo approved in Canada for use across all authorised solid tumour indications
27 May 2025 - Subcutaneous option of established immunotherapy offers potential to reduce time in clinic and ease infusion burden. ...
Posted by Michael Wonder on 28 May 2025
Ocugen announces rare paediatric disease designation granted for OCU410ST—modifier gene therapy for the treatment of Stargardt disease
27 May 2025 - Ocugen today announced that the US FDA has granted rare paediatric disease designation for OCU410ST for the ...
Posted by Michael Wonder on 27 May 2025
Teva celiac disease candidate granted fast track designation by US FDA
27 May 2025 - Designation underscores the potential of TEV-53408, currently undergoing a Phase 2a study for the treatment of celiac ...
Posted by Michael Wonder on 27 May 2025
BeiGene receives positive CHMP opinion for Tevimbra as a first-line treatment for nasopharyngeal cancer
27 May 2025 - Positive opinion for Tevimbra in combination with chemotherapy as a first-line treatment of nasopharyngeal cancer based ...
Posted by Michael Wonder on 27 May 2025
ICER releases draft evidence report on treatments for spinal muscular atrophy
27 May 2025 - Public comment period now open until 24 June 2025; requests to make oral comment during public ...
Posted by Michael Wonder on 27 May 2025
Savara receives refusal to file letter from the US FDA for the biologics license application for Molbreevi to treat patients with auto-immune pulmonary alveolar proteinosis
27 May 2025 - Savara today announced that the Company received a refusal to file letter from the FDA for ...
Posted by Michael Wonder on 27 May 2025
Imfinzi recommended for approval in the EU by CHMP as first and only peri-operative immunotherapy for muscle-invasive bladder cancer
27 May 2025 - Recommendation based on NIAGARA Phase III trial results which showed a 32% reduction in the risk of ...
Posted by Michael Wonder on 27 May 2025
Arcutis’ Zoryve (roflumilast) 0.3% topical foam approved by US FDA for the treatment of plaque psoriasis in adults and adolescents ages 12 and older
22 May 2025 - Fifth FDA approval for Zoryve in less than three years. ...