Blog
RSS FeedPosted by Michael Wonder on 02 May 2022
Junshi Biosciences and Coherus receive complete response letter from U.S. FDA for toripalimab BLA
2 May 2022 - The complete response letter requests a quality process change Junshi Biosciences and Coherus believe is readily addressable. ...
Posted by Michael Wonder on 02 May 2022
Axsome Therapeutics receives FDA complete response letter for new drug application for AXS-07 for the acute treatment of migraine
2 May 2022 - No clinical efficacy or safety issues raised and no additional clinical studies required by FDA to support ...
Posted by Michael Wonder on 02 May 2022
U.S. FDA declines to approve two more China tested drugs
2 May 2022 - The U.S. FDA declined to approve two China tested cancer treatments on Monday, raising concerns over ...
Posted by Michael Wonder on 01 May 2022
Moderna submits COVID-19 vaccine for kids 5 and under to Health Canada for review
29 April 2022 - Moderna has asked Health Canada to approve its COVID-19 vaccine for children as young as six ...
Posted by Michael Wonder on 01 May 2022
Moderna files to expand conditional marketing authorisation for its COVID-19 vaccine to include children six months to under six years in the European Union
29 April 2022 - The filing follows the European Medicines Agency's Committee for Medicinal Products for Human Use recent decision ...
Posted by Michael Wonder on 30 Apr 2022
Supernus announces FDA approval of Qelbree for the treatment of attention deficit hyperactivity disorder in adults
29 April 2022 - First novel, non-stimulant option for adults with ADHD in 20 years. ...
Posted by Michael Wonder on 29 Apr 2022
Rinvoq (upadacitinib) approved by U.S. FDA as an oral treatment for adults with active ankylosing spondylitis
29 April 2022 - Across the two pivotal trials, Rinvoq delivered rapid and meaningful disease control with nearly half of ankylosing ...
Posted by Michael Wonder on 29 Apr 2022
Fennec Pharmaceuticals announces FDA acceptance for filing of new drug application resubmission for Pedmark
27 April 2022 - Prescription Drug User Fee Act target action date set for 23 September 2022. ...
Posted by Michael Wonder on 29 Apr 2022
U.S. Food and Drug Administration approves Camzyos (mavacamten) for the treatment of adults with symptomatic New York Heart Association class II-III obstructive hypertrophic cardiomyopathy to improve functional capacity and symptoms
28 April 2022 - Camzyos is the first and only FDA approved cardiac myosin inhibitor that specifically targets the source of ...
Posted by Michael Wonder on 29 Apr 2022
Timber Pharmaceuticals announces fast track designation granted by FDA for TMB-001 in severe subtypes of congenital ichthyosis
28 April 2022 - Company expects to launch pivotal Phase 3 ASCEND clinical trial to evaluate TMB-001 within the next ...
Posted by Michael Wonder on 29 Apr 2022
Moderna files for authorisation of its COVID-19 vaccine in young children six months to under six years of age
28 April 2022 - Submission to regulators globally is based on Phase 2/3 studies of mRNA-1273 in young children. ...
Posted by Michael Wonder on 28 Apr 2022
Janssen submits marketing authorisation application to EMA seeking approval of niraparib and abiraterone acetate dual action tablet plus prednisone for the treatment of patients with HRR gene mutated metastatic castration resistant prostate cancer
28 April 2022 - The submission to the EMA is based on results from the Phase 3 MAGNITUDE study evaluating niraparib ...
Posted by Michael Wonder on 28 Apr 2022
COVID-19 vaccine weekly safety report (28 April 2022)
28 April 2022 - To 24 April 2022, the TGA has received 544 reports which have been assessed as likely to ...
Posted by Michael Wonder on 28 Apr 2022
FDA approves Mycovia Pharmaceuticals’ Vivjoa (oteseconazole), the first and only FDA approved medication for recurrent vulvovaginal candidiasis
28 April 2022 - U.S. commercial launch of Vivjoa expected in Q2, ...
Posted by Michael Wonder on 28 Apr 2022
TGA grants provisional determination for the Moderna bivalent COVID-19 vaccine "Spikevax Bivalent Zero/Omicron"
28 April 2022 - On 27 April 2022, the TGA granted a provisional determination to Moderna in relation to its ...