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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
AbbVie receives European Commission approval of Venclyxto (venetoclax) in combination with a hypomethylating agent for patients with newly diagnosed acute myeloid leukaemia who are ineligible for intensive chemotherapy
25 May 2021 - Venclyxto (venetoclax) in combination with a hypomethylating agent is a new regimen approved by the European ...
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
Merck receives positive EU CHMP opinion for Keytruda (pembrolizumab) in combination with chemotherapy as first-line treatment for certain patients with oesophageal cancer or HER2 negative gastro-oesophageal junction adenocarcinoma
24 May 2021 - Recommendation based on significant survival benefit demonstrated with Keytruda plus chemotherapy versus chemotherapy in Phase 3 KEYNOTE-590 ...
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 25 May 2021
European Medicines Agency grants BioMarin's request for accelerated assessment of valoctocogene roxaparvovec for treatment of severe haemophilia A
24 May 2021 - MAA resubmission on track for June 2021. ...
Posted by Michael Wonder on 25 May 2021
European Commission approves Ponvory (ponesimod) for the treatment of adults with relapsing forms of multiple sclerosis with active disease defined by clinical or imaging features
25 May 2021 - Idorsia was informed by the Janssen that the European Commission has approved Ponvory (ponesimod) for the treatment ...
Posted by Michael Wonder on 25 May 2021
TGA approves more flexible storage conditions for Pfizer-BioNTech COVID-19 vaccine
24 May 2021 - Today, the TGA approved an application from Pfizer to change its current storage conditions for its ...
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 24 May 2021
Almirall receives positive CHMP opinion for Klisyri (tirbanibulin), an innovative topical treatment for actinic keratosis
21 May 2021 - Klisyri (tirbanibulin) is a novel microtubule inhibitor, indicated for the topical treatment of actinic keratosis of the ...
Posted by Michael Wonder on 24 May 2021
Libtayo (cemiplimab) receives positive CHMP opinion for the treatment in Europe of two advanced cancers
24 May 2021 - CHMP has now issued three positive opinions for Libtayo in advanced cancers. ...