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RSS FeedPosted by Michael Wonder on 25 May 2021
President Biden still hasn’t appointed a permanent FDA commissioner. That has big implications for upcoming drug approvals.
25 May 2021 - Within the next few weeks, the FDA is set to make an extraordinary decision: whether or not ...
Posted by Michael Wonder on 25 May 2021
TherapeuticsMD announces submission of low dose Bijuva 0.5 mg/100 mg supplemental new drug application to FDA
25 May 2021 - TherapeuticsMD announced today that the Company submitted a supplemental new drug application for BIJUVA (oestradiol and ...
Posted by Michael Wonder on 25 May 2021
TG Therapeutics announces FDA acceptance of biologics license application for ublituximab in combination with Ukoniq (umbralisib) as a treatment for patients with chronic lymphocytic leukaemia and small lymphocytic lymphoma
25 May 2021 - Prescription Drug User Fee Act goal date of 25 March 2022. ...
Posted by Michael Wonder on 25 May 2021
Scholar Rock receives fast track designation from the U.S. FDA for apitegromab for the treatment of patients with spinal muscular atrophy
24 May 2021 - Builds on Priority Medicines (PRIME) designation recently granted by the EMA recognising the unmet medical needs of ...
Posted by Michael Wonder on 25 May 2021
Verastem Oncology receives breakthrough therapy designation for VS-6766 with defactinib in recurrent low grade serous ovarian cancer
24 May 2021 - Results of early trial demonstrate 70% overall response rate in patients with KRAS mutant tumours, 44% ...
Posted by Michael Wonder on 24 May 2021
Akeso's penpulimab monoclonal antibody submitted BLA in the United States
24 May 2021 - First Chinese PD-1 drug being BLA reviewed by the FDA under real-time oncology review. ...
Posted by Michael Wonder on 24 May 2021
Boehringer Ingelheim's investigational treatment for cognitive impairment associated with schizophrenia receives FDA breakthrough therapy designation
24 May 2021 - BI 425809, a novel glycine transporter-1 (GlyT1) inhibitor to be studied in first of its kind Phase ...
Posted by Michael Wonder on 24 May 2021
Adjusting for covariates in randomised clinical trials for drugs and biological products
20 May 2021 - This guidance represents FDA’s current thinking on adjusting for covariates in the statistical analysis of randomised clinical ...
Posted by Michael Wonder on 21 May 2021
FDA grants accelerated approval to amivantamab-vmjw for metastatic non-small cell lung cancer
21 May 2021 - Today, the FDA granted accelerated approval to amivantamab-vmjw (Rybrevant, Janssen), a bispecific antibody directed against epidermal ...
Posted by Michael Wonder on 21 May 2021
U.S. FDA grants priority review of maribavir for the treatment of post-transplant recipients with cytomegalovirus infection in those resistant and/or refractory to prior anti-CMV treatment
21 May 2021 - New drug application based on Phase 3 trial of maribavir which met its primary outcome of superiority ...
Posted by Michael Wonder on 20 May 2021
Omeros announces extension of FDA review period for narsoplimab in HSCT-TMA
20 May 2021 - PDUFA date is 17 October 2021. ...
Posted by Michael Wonder on 20 May 2021
FDA approves nivolumab for resected oesophageal or GEJ cancer
20 May 2021 - Today the FDA approved nivolumab (Opdivo, Bristol-Myers Squibb) for patients with completely resected oesophageal or gastro-oesophageal ...
Posted by Michael Wonder on 20 May 2021
FDA authorises longer time for refrigerator storage of thawed Pfizer-BioNTech COVID-19 vaccine prior to dilution, making vaccine more widely available
19 May 2021 - Based on a review of recent data submitted by Pfizer today, the U.S. FDA is authorising undiluted, ...
Posted by Michael Wonder on 19 May 2021
Leading real world data and analytics organisations form industry coalition to advance policies to support regulatory use of real world evidence
19 May 2021 - RWE Alliance Launched by Aetion, Flatiron Health, IQVIA, Syapse, and Tempus. ...
Posted by Michael Wonder on 19 May 2021
BioXcel Therapeutics announces FDA acceptance for filing of NDA for BXCL501 for the acute treatment of agitation associated with schizophrenia and bipolar disorders I and II
19 May 2021 - FDA sets PDUFA action date for 5 January 2022. ...