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RSS FeedPosted by Michael Wonder on 28 Jul 2021
Apic Bio receives FDA fast track designation for APB-102 for the treatment of patients with SOD1 ALS
28 July 2021 - Apic Bio today announced that the U.S. FDA has granted fast track designation to APB-102, the ...
Posted by Michael Wonder on 28 Jul 2021
FDA says its 'working as quickly as possible' to review for full approval of vaccines
27 July 2021 - Some say full approval could sway hesitant Americans to get the vaccine. ...
Posted by Michael Wonder on 28 Jul 2021
Lyndra Therapeutics’ investigational oral, weekly opioid use disorder treatment LYN-014 granted fast track designation by FDA
27 July 2021 - LYN-014 has the potential to address significant public health concerns about access to opioid use disorder treatment and ...
Posted by Michael Wonder on 27 Jul 2021
J&J and Pfizer quietly resolve Remicade biosimilar lawsuit
27 July 2021 - In 2017, Pfizer filed a lawsuit against J&J alleging that the company undertook anticompetitive practices in a ...
Posted by Michael Wonder on 27 Jul 2021
Sol-Gel Technologies announces FDA approval of Twyneo
27 July 2021 - Twyneo utilizes Sol-Gel’s proprietary microencapsulation technology and is patent protected until 2038. ...
Posted by Michael Wonder on 27 Jul 2021
How Biogen found a believer: at the FDA, a hard nosed regulator was won over on controversial Alzheimer’s drug
27 July 2021 - When the drug maker Biogen pitched its Alzheimer’s treatment to a panel of independent experts last ...
Posted by Michael Wonder on 27 Jul 2021
Day One receives FDA rare paediatric disease designation for DAY101 for the treatment of paediatric low grade glioma
27 July 2021 - Day One Biopharmaceuticals today announced that the U.S. FDA has granted rare paediatric disease designation to the ...
Posted by Michael Wonder on 27 Jul 2021
FDA approves Keytruda (pembrolizumab) for treatment of patients with high-risk early stage triple negative breast cancer in combination with chemotherapy as neo-adjuvant treatment, then continued as single agent as adjuvant treatment after surgery
27 July 2021 - Keytruda is now approved in the US for 30 indications. ...
Posted by Michael Wonder on 26 Jul 2021
Using updated PubMed: new features and functions to enhance literature searches
26 July 2021 - In the past 2 years, PubMed has been updated to improve functionality and add important new features, ...
Posted by Michael Wonder on 26 Jul 2021
Evren Technologies receives FDA breakthrough device designation for the Phoenix
21 July 2021 - Evren Technologies announced today that its non-invasive Phoenix earbud device received Breakthrough Device Designation from the ...
Posted by Michael Wonder on 26 Jul 2021
FDA asks Pfizer, Moderna to test their vaccines in more children to help rule out safety issues
26 July 2021 - Federal regulators have requested that vaccine companies expand their trials to test coronavirus shots in several ...
Posted by Michael Wonder on 26 Jul 2021
Shingrix approved in the US for prevention of shingles in immunocompromised adults
26 July 2021 - GlaxoSmithKline today announced that the US FDA has approved Shingrix (zoster vaccine recombinant, adjuvanted) for the prevention ...
Posted by Michael Wonder on 26 Jul 2021
Full FDA approval is needed to overcome vaccine hesitancy
26 July 2021 - As the Delta variant spreads, what is the agency waiting for? ...
Posted by Michael Wonder on 26 Jul 2021
Iterum Therapeutics receives complete response letter from U.S. FDA for oral sulopenem
26 July 2021 - Iterum Therapeutics today announced that it received a complete response letter from the U.S. FDA for its ...
Posted by Michael Wonder on 26 Jul 2021
Aadi Bioscience announces FDA acceptance and priority review for the new drug application of Fyarro for the treatment of advanced malignant PEComa
26 July 2021 - FDA grants priority review and sets PDUFA target action date of 26 November 2021 ...