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RSS FeedPosted 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
Third member of prestigious FDA panel resigns over approval of Biogen's Alzheimer's drug
10 June 2021 - A third member of a key FDA advisory panel has resigned over the agency's controversial decision to ...
Posted by Michael Wonder on 11 Jun 2021
Sanofi provides update on Aubagio (teriflunomide) submission for children and adolescents with relapsing-remitting multiple sclerosis in the U.S
11 June 2021 - The U.S. FDA has issued a complete response letter regarding the supplemental new drug application for ...
Posted by Michael Wonder on 11 Jun 2021
Moderna files for emergency use authorisation for its COVID-19 vaccine in adolescents in the United States
10 June 2021 - Submission based on Phase 2/3 trial of mRNA-1273 in adolescents ages 12 to less than 18 ...
Posted by Michael Wonder on 11 Jun 2021
U.S. FDA approves new formulation of Epclusa, expanding paediatric indication to treat children ages 3 and older with chronic hepatitis C
10 June 2021 - Gilead Sciences announced today that the U.S. FDA has approved an expansion of the pediatric indication of ...
Posted by Michael Wonder on 10 Jun 2021
America’s approval of an Alzheimer’s drug is premature
12 June 2021 - It may offer false hope and divert resources from more promising therapies. ...
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
Core patient reported outcomes in cancer clinical trials
9 June 2021 - This guidance provides recommendations to sponsors for collection of a core set of patient reported clinical outcomes ...
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 10 Jun 2021
CyMedica Orthopedics announces FDA clearance for IntelliHab, a novel drug free, non-invasive modality for treatment of knee osteoarthritis pain
9 June 2021 - CyMedica Orthopedics today announced the U.S. FDA has cleared the submission of its latest technology for ...
Posted by Michael Wonder on 10 Jun 2021
Two members of U.S. FDA advisory panel resign over Alzheimer's drug approval
9 June 2021 - Two members of a panel of outside advisors to the U.S. FDA have resigned in protest ...
Posted by Michael Wonder on 09 Jun 2021
Vertex announces U.S. FDA approval for Trikafta (elexacaftor/tezacaftor/ivacaftor and ivacaftor) in children with cystic fibrosis ages 6 through 11 with certain mutations
9 June 2021 - With this approval approximately 1,500 children with one minimal function mutation and one F508del mutation have a ...
Posted by Michael Wonder on 09 Jun 2021
Ibex granted FDA breakthrough device designation
9 June 2021 - Ibex's Galen AI powered platform is recognised by the FDA as breakthrough technology with the potential to ...
Posted by Michael Wonder on 09 Jun 2021
Millions of J&J COVID-19 vaccines are at risk of expiring in June
8 June 2021 - States, hospitals try to reroute such vaccines, while efforts to export them face hurdles. ...
Posted by Michael Wonder on 09 Jun 2021
US FDA approves Prevnar 20, Pfizer’s pneumococcal 20 valent conjugate vaccine for adults ages 18 years or older
8 June 2021 - First approval of a conjugate vaccine that helps protect against 20 serotypes responsible for the majority of ...