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RSS FeedPosted by Michael Wonder on 30 Mar 2022
EMA starts rolling review of COVID-19 vaccine HIPRA (PHH-1V)
29 March 2022 - EMA’s CHMP has started a rolling review of COVID-19 Vaccine HIPRA (also known as PHH-1V). ...
Posted by Michael Wonder on 30 Mar 2022
Enanta Pharmaceuticals receives FDA fast track designation for EDP-235, its oral 3CL protease inhibitor specifically designed for the treatment and prevention of COVID-19
29 March 2022 - Enanta Pharmaceuticals today announced that the U.S. FDA has granted fast track designation for EDP-235, its ...
Posted by Michael Wonder on 30 Mar 2022
ImmunoGen submits biologics license application to the US Food and Drug Administration for mirvetuximab soravtansine in ovarian cancer
29 March 2022 - Submission based on positive results from pivotal Phase 3 SORAYA trial. ...
Posted by Michael Wonder on 30 Mar 2022
Drug trials a ‘ticking time bomb’: ex-TGA agent
28 March 2022 - A former TGA official who led the regulator’s inspections program has warned that a lack of ...
Posted by Michael Wonder on 29 Mar 2022
FDA authorises second booster dose of two COVID-19 vaccines for older and immunocompromised individuals
29 March 2022 - Today, the U.S. FDA authorised a second booster dose of either the Pfizer-BioNTech or the Moderna COVID-19 ...
Posted by Michael Wonder on 29 Mar 2022
European Medicines Agency validates Bristol Myers Squibb’s application for Opdivo (nivolumab) with chemotherapy as neo-adjuvant treatment for resectable non-small-cell lung cancer
29 March 2022 - Application based on CheckMate-816, the only Phase 3 trial to demonstrate improved event-free survival and pathologic complete ...
Posted by Michael Wonder on 29 Mar 2022
Gadopiclenol marketing authorisation dossier submissions accepted for review by EMA and FDA
29 March 2022 - Priority review granted by U.S. FDA. ...
Posted by Michael Wonder on 29 Mar 2022
Lipocine announces its partner received FDA approval of Tlando
29 March 2022 - Commercial launch expected in 2Q 2022. ...
Posted by Michael Wonder on 29 Mar 2022
Novo Nordisk receives FDA approval of higher-dose Ozempic 2 mg providing increased glycemic control for adults with type 2 diabetes
28 March 2022 - Ozempic demonstrated 2.1% blood sugar reduction and also weight loss in adults with type 2 diabetes ...
Posted by Michael Wonder on 29 Mar 2022
Santhera and ReveraGen start rolling NDA submission to the FDA for vamorolone for the treatment of Duchenne muscular dystrophy
29 March 2022 - Santhera Pharmaceuticals and ReveraGen BioPharma announce the initiation of a rolling new drug application submission to the ...
Posted by Michael Wonder on 29 Mar 2022
Consequences of US FDA approval decisions in high-income countries
29 March 2022 - Akhade and colleagues highlight the global consequences of approving cancer medicines on the basis of uncertain evidence ...
Posted by Michael Wonder on 29 Mar 2022
European Medicines Agency commences review of novel gene therapy candidate etranacogene dezaparvovec for people with haemophilia B
29 March 2022 - Marketing authorisation application for etranacogene dezaparvovec will be reviewed under accelerated assessment and has the potential to ...
Posted by Michael Wonder on 29 Mar 2022
Seqirus receives Health Canada approval for expanded age indication of its cell-based quadrivalent influenza vaccine for people as young as six months
28 March 2022 - Seqirus announced today that it has received Health Canada approval of Flucelvax Quad (influenza vaccine), its cell-based ...
Posted by Michael Wonder on 28 Mar 2022
Dupixent (dupilumab injection) now approved in Canada for the treatment of severe asthma in children aged six to 11 years with type 2 inflammation
28 March 2022 - This is the sixth indication for Dupixent in Canada, its second in asthma, and its second in ...
Posted by Michael Wonder on 28 Mar 2022
U.S. FDA approves Fintempla (fenfluramine) oral solution for treatment of seizures associated with Lennox-Gastaut syndrome
28 March 2022 - Approval based on data where fenfluramine demonstrated efficacy in the most difficult to treat seizure types, including ...