Blog
RSS FeedPosted by Michael Wonder on 17 Jan 2022
ATAGI update following weekly COVID-19 meeting (12 January 2022)
17 January 2022 - Previously, severely immunocompromised people aged 12 years and older were recommended to receive a third primary dose ...
Posted by Michael Wonder on 16 Jan 2022
Ascendis Pharma receives European Approval for TransCon hGH for paediatric growth hormone deficiency
13 January 2022 - TransCon hGH (approved by the European Commission as Lonapegsomatropin Ascendis Pharma) is a once-weekly prodrug of somatropin ...
Posted by Michael Wonder on 16 Jan 2022
COVID-19 vaccine weekly safety report (13 January 2022)
13 January 2022 - To 9 January 2022, the TGA has received 952 reports which have been assessed as likely to ...
Posted by Michael Wonder on 16 Jan 2022
COVID-19 vaccine weekly safety report (6 January 2022)
17 January 2022 - To 2 January 2022, the TGA has received 415 reports which have been assessed as likely to ...
Posted by Michael Wonder on 16 Jan 2022
Accelerating clinical trials in the EU: for better clinical trials that address patients’ need
13 January 2022 - Today, the European Commission, the Heads of Medicines Agencies and the EMA have launched an initiative to ...
Posted by Michael Wonder on 16 Jan 2022
Glenmark receives NDA approval by the United States FDA for Ryaltris nasal spray for the treatment of symptoms of seasonal allergic rhinitis in adults and paediatric patients 12 years of age and older
14 January 2022 - Ryaltris will be marketed and distributed in the United States through its partner Hikma. ...
Posted by Michael Wonder on 16 Jan 2022
Global regulators discuss path towards regulatory alignment on response to Omicron variant
13 January 2022 - On 12 January, regulators from around the world discussed the global regulatory response to the COVID-19 Omicron ...
Posted by Michael Wonder on 15 Jan 2022
U.S. FDA approves Pfizer’s Cibinqo (abrocitinib) for adults with moderate to severe atopic dermatitis
14 January 2022 - Cibinqo is a once daily oral treatment with proven efficacy to manage symptoms for adults who ...
Posted by Michael Wonder on 14 Jan 2022
Advancing health through innovation: new drug therapy approvals 2021
13 January 2022 - The FDA’s Center for Drug Evaluation and Research has issued its report, Advancing Health Through Innovation: New ...
Posted by Michael Wonder on 14 Jan 2022
U.S. FDA approves Rinvoq (upadacitinib) to treat adults and children 12 years and older with refractory, moderate to severe atopic dermatitis
14 January 2022 - Approval of two dose strengths (15 mg and 30 mg) supported by efficacy and safety data from ...
Posted by Michael Wonder on 14 Jan 2022
Celltrion wins conditional nod for Regkirona in Switzerland
14 January 2022 - Celltrion said that Swiss Medic, Switzerland’s drug administration, has temporary authorisation for Regkirona (regdanvimab). ...
Posted by Michael Wonder on 14 Jan 2022
Senate panel advances Biden's FDA pick in 13-8 vote
13 January 2022 - Two senators on the panel who caucus with Democrats and six Republicans opposed the nomination. ...
Posted by Michael Wonder on 14 Jan 2022
GSK and Vir submit emergency use authorisation application to FDA for intramuscular administration of sotrovimab for the early treatment of COVID-19
13 January 2022 - Submission follows COMET-TAIL Phase 3 data demonstrating that intramuscular administration of sotrovimab was non-inferior and offered ...
Posted by Michael Wonder on 13 Jan 2022
The US FDA issues a complete response letter for the biologics license application for insulin aspart
7 January 2022 - The U.S. FDA has issued a complete response letter for the biologics license application for insulin ...
Posted by Michael Wonder on 13 Jan 2022
CBMG receives FDA regenerative medicine advanced therapy and fast track designations for bi-Specific anti-CD19/CD20 CAR-T cell therapy for relapsed/refractory B-cell non-Hodgkin lymphoma
12 January 2022 - Cellular Biomedicine Group today announced that the FDA granted C-CAR039, a novel autologous bi-specific CAR-T therapy targeting ...