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RSS FeedPosted by Michael Wonder on 17 Jun 2021
Amneal announces U.S. FDA filing acceptance of biologics license application for bevacizumab
17 June 2021 - Bevacizumab represents the third biosimilar BLA currently filed by Amneal with the FDA. ...
Posted by Michael Wonder on 17 Jun 2021
Eagle Pharmaceuticals submits response to complete response letter from FDA for vasopressin
17 June 2021 - Eagle Pharmaceuticals today announced that it has responded to the complete response letter for its abbreviated ...
Posted by Michael Wonder on 16 Jun 2021
Braeburn resubmits new drug application for Brixadi (buprenorphine) extended release subcutaneous injection for moderate to severe opioid use disorder
15 June 2021 - Braeburn announces that today the new drug application for Brixadi (buprenorphine) extended release injection for subcutaneous ...
Posted by Michael Wonder on 16 Jun 2021
Emmaus Life Sciences announces submission of marketing authorisation application to Swissmedic; Ideogen to manage early access program
15 June 2021 - Emmaus Life Sciences anounced today it has received confirmation from the Swiss Agency for Therapeutic Products ...
Posted by Michael Wonder on 15 Jun 2021
Hugel America announces U.S. FDA acceptance of biologics license application for letibotulinumtoxinA for injection to treat glabellar (frown) lines
15 June 2021 - Prescription Drug User Fee Act target action date of 31 March 2022. ...
Posted by Michael Wonder on 15 Jun 2021
Amylyx Pharmaceuticals files new drug submission for AMX0035 for the treatment of ALS in Canada
14 June 2021 - Submission supported by data from the CENTAUR trial. ...
Posted by Michael Wonder on 15 Jun 2021
Moderna seeks vaccine approval for adolescents
11 June 2021 - US-based biotech company Moderna is applying for the use of its COVID-19 vaccine for adolescents aged 12 ...
Posted by Michael Wonder on 14 Jun 2021
Ascendis Pharma announces extension of U.S. FDA review period for TransCon hGH (onapegsomatropin) for paediatric growth hormone deficiency
11 June 2021 - Prescription Drug User Fee Act goal date extended by three months for further review of submission to ...
Posted by Michael Wonder on 11 Jun 2021
Incyte announces U.S. FDA has extended the new drug application review period for ruxolitinib cream for the treatment of atopic dermatitis
11 June 2021 - Incyte announced today that the U.S. FDA has extended the review period for the new drug ...
Posted by Michael Wonder on 11 Jun 2021
Controversial Alzheimer’s drug approved in U.S. Where does Canada stand?
10 June 2021 - The Alzheimer Society of Canada welcomed the new treatment urging Canadian health authorities to complete its required ...
Posted by Michael Wonder on 10 Jun 2021
FDA accepts filing of abbreviated new drug application and grants priority review for nalmefene hydrochloride injection for the treatment of known or suspected opioid overdose
10 June 2021 - Purdue Pharma announced that FDA has accepted and granted priority review to the company’s abbreviated new ...
Posted by Michael Wonder on 10 Jun 2021
Adamis provides update on Zimhi
9 June 2021 - FDA deems new drug application for Zimhi complete and establishes a target action date of 12 November ...
Posted by Michael Wonder on 09 Jun 2021
BeiGene announces acceptance of a supplemental biologics license application in China for tislelizumab in microsatellite instability-high or mismatch repair-deficient solid tumours
7 June 2021 -BeiGene today announced that the Center for Drug Evaluation of the China NMPA has accepted a supplemental ...
Posted by Michael Wonder on 08 Jun 2021
Incyte announces U.S. FDA has extended the sNDA review period for ruxolitinib (Jakafi) in chronic graft versus host disease
8 June 2021 - Incyte today announced that the U.S. FDA has extended the review period for the supplemental new drug ...
Posted by Michael Wonder on 08 Jun 2021
Moderna files for authorisation with Health Canada for its COVID-19 vaccine in adolescents
7 June 2021 - Submission based on Phase 2/3 study of mRNA-1273 in adolescents ages 12 to less than 18 ...