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RSS FeedPosted 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
Copiktra (duvelisib) receives European Union marketing authorisation for the treatment of relapsed or refractory CLL and refractory FL
9 June 2021 - Secura Bio today announced that on 19 May 2021, the European Medicines Agency granted marketing authorisation 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
Paladin Labs announces approval of Wakix (pitolisant) in Canada
9 June 2021 - Paladin Labs today announced Health Canada's approval of Wakix (pitolisant) for the treatment of excessive daytime sleepiness ...
Posted by Michael Wonder on 09 Jun 2021
New Alzheimer’s drug unlikely to be approved in Australia soon, say experts
9 June 2021 - A controversial new drug that has offered hope to Alzheimer’s sufferers by slowing cognitive decline still ...
Posted by Michael Wonder on 09 Jun 2021
Australia tipped to approve Pfizer vaccine for children this year
9 June 2021 - Infectious diseases paediatricians and vaccine experts anticipate the Pfizer shot could be approved for use in ...
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
Glaukos Announces Australia’s TGA regulatory approval for Preserflo MicroShunt
8 June 2021 - Glaukos Corporation today announced that the TGA has granted regulatory approval for the Preserflo MicroShunt intended for ...
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 ...
Posted by Michael Wonder on 08 Jun 2021
Biogen faces tough questions over $56,000 a year price of newly approved Alzheimer’s drug
8 June 2021 - The biotech company’s price for the drug is higher than the $10,000 to $25,000 some Wall Street ...
Posted by Michael Wonder on 08 Jun 2021
Alpha Tau receives breakthrough device designation from the FDA for Alpha DaRT
8 June 2021 - Alpha Tau Medical is pleased to announce that it has received a breakthrough device designation for Alpha ...
Posted by Michael Wonder on 08 Jun 2021
VBI Vaccines granted FDA fast track designation for VBI-1901 for the treatment of recurrent GBM
8 June 2021 - Designation granted based on data from the Phase 1/2a study of VBI-1901 in recurrent GBM patients. ...
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 ...