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RSS FeedPosted by Michael Wonder on 28 Jun 2023
Facilitating review of real world data studies: the oncology QCARD initiative
27 June 2023 - Expanding ways to generate evidence can lead to an array of benefits for medical product development, including ...
Posted by Michael Wonder on 28 Jun 2023
How the shortage of a $15 cancer drug is upending treatment
26 June 2023 - Older generic chemotherapy drugs remain scarce, forcing doctors to put a priority on the patients who have ...
Posted by Michael Wonder on 28 Jun 2023
Verona Pharma submits new drug application to US FDA for ensifentrine for the maintenance treatment of COPD
27 June 2023 - Verona Pharma announces the submission of a new drug application to the US FDA for approval ...
Posted by Michael Wonder on 27 Jun 2023
Allecra Therapeutics submits new drug application to the US FDA for Exblifep for the treatment of complicated urinary tract infections
27 June 2023 - Allecra Therapeutics announced today the submission of a new drug application to the US FDA for ...
Posted by Michael Wonder on 27 Jun 2023
FDA issues complete response letter for aflibercept 8 mg biologics license application solely due to an on-going review of inspection findings at a third-party filler
27 June 2023 - No issues with clinical efficacy or safety, trial design, labeling or drug substance manufacturing were identified in ...
Posted by Michael Wonder on 27 Jun 2023
UCB provides update on US FDA review of the biologics license application for bimekizumab
26 June 2023 - UCB today announced that the biologics license application for bimekizumab for the treatment of adults with ...
Posted by Michael Wonder on 27 Jun 2023
UCB announces US FDA approval of Rystiggo (rozanolixizumab-noli) for the treatment of adults with generalised myasthenia gravis
27 June 2023 - US FDA approval is based on the pivotal Phase 3 MycarinG study in gMG2, a large phase ...
Posted by Michael Wonder on 24 Jun 2023
FDA approves Pfizer’s Litfulo (ritlecitinib) for adults and adolescents with severe alopecia areata
23 June 2023 - Litfulo is the first and only treatment for severe alopecia areata approved for patients as young ...
Posted by Michael Wonder on 23 Jun 2023
Intercept receives complete response letter from FDA for obeticholic acid as a treatment for pre-cirrhotic fibrosis due to NASH
22 June 2023 - Company to discontinue all NASH-related investment and restructure the Company’s operations to strengthen its focus on rare ...
Posted by Michael Wonder on 22 Jun 2023
Cidara Therapeutics receives US FDA fast track designation for CD388, a novel drug-FC conjugate targeting influenza A and B
22 June 2023 - Cidara Therapeutics today announced that the US FDA has granted fast track designation to CD388, Cidara’s novel ...
Posted by Michael Wonder on 22 Jun 2023
Transitional coverage for emerging technologies
22 June 2023 - The Centers for Medicare & Medicaid Services issued a proposed procedural notice outlining a new Medicare coverage ...
Posted by Michael Wonder on 22 Jun 2023
Aldeyra Therapeutics provides regulatory update on ADX-2191
21 June 2023 - Based on US FDA determination of lack of adequate and well controlled investigations in the scientific literature, ...
Posted by Michael Wonder on 22 Jun 2023
ARS Pharmaceuticals announces PDUFA date extension for neffy (intranasal epinephrine) for the treatment of allergic reactions (type 1), including anaphylaxis
20 June 2023 - Additional time needed for labelling and post-marketing requirements discussions; PDUFA date set for 19 September 2023. ...
Posted by Michael Wonder on 22 Jun 2023
Calliditas Therapeutics submits supplemental new drug application to US FDA for full approval of Tarpeyo
21 June 2023 - Calliditas Therapeutics today announced the submission of a supplemental new drug application to the US FDA ...
Posted by Michael Wonder on 21 Jun 2023
FDA grants full approval for Blincyto (blinatumomab) to treat minimal residual disease positive B-cell precursor acute lymphoblastic leukaemia
21 June 2023 - Conversion from accelerated to full approval. ...