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RSS FeedPosted by Michael Wonder on 26 May 2021
Unity HA awarded breakthrough device designation for implantable neurostimulation technology to treat cluster headache pain
25 May 2021 - Unity HA announced today that the U.S. FDA has granted breakthrough device designation to the Pulsante SPG ...
Posted by Michael Wonder on 26 May 2021
Illuminare-1, a novel nerve visualisation investigational fluorophore, granted fast track designation by U.S. FDA
25 May 2021 - Illuminare Biotechnologies announced that its novel nerve imaging agent, Illuminare-1, has been granted fast track designation by ...
Posted by Michael Wonder on 25 May 2021
Adjusting for non-adherence or stopping treatments in randomised clinical trials
25 May 2021 - Randomised clinical trials allocate individuals to different treatments, or, more generally, to interventions and comparators, to determine ...
Posted by Michael Wonder on 25 May 2021
Spinal Stabilization Technologies earns FDA breakthrough designation for PerQdisc nucleus replacement system for degenerative disc disease
25 May 2021 - Spinal Stabilization Technologies announced today that it has earned the CE Mark and the FDA's breakthrough ...
Posted 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. ...