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RSS FeedPosted by Michael Wonder on 02 Nov 2021
I’ve worked with Robert Califf. He is the leader the FDA needs.
2 November 2021 - If the cascade of news reports are true, President Biden is finally about to name his choice ...
Posted by Michael Wonder on 02 Nov 2021
EMA ends rolling review of the antibodies bamlanivimab and etesevimab for COVID-19 following withdrawal by Lilly
2 November 2021 - EMA has ended the rolling review of bamlanivimab and etesevimab, two antibodies for the treatment of ...
Posted by Michael Wonder on 02 Nov 2021
Otsuka submits initial marketing authorization application to the European Medicines Agency for vadadustat for the treatment of adults with anemia associated with chronic kidney disease
29 October 2021 - Otsuka announces that Otsuka Pharmaceutical Netherlands has submitted an initial marketing authorisation application to the EMA for ...
Posted by Michael Wonder on 02 Nov 2021
Novavax files for COVID-19 vaccine authorisation with Health Canada and completes submission for rolling review to European Medicines Agency
1 November 2021 - Submission of all modules required for regulatory review, including CMC and clinical data, are now complete ...
Posted by Michael Wonder on 02 Nov 2021
Moderna provides update on timing of U.S. emergency use authorisation of its COVID-19 vaccine for adolescents
31 October 2021 - Moderna today provided an update that the U.S. FDA has notified the Company that it will ...
Posted by Michael Wonder on 02 Nov 2021
Junshi Biosciences and Coherus announce FDA acceptance of BLA filing for toripalimab for treatment of nasopharyngeal carcinoma
1 November 2021 - FDA has granted the toripalimab BLA Priority Review with a target action date of April 2022. ...
Posted by Michael Wonder on 02 Nov 2021
ANI Pharmaceuticals announces FDA approval of purified cortrophin gel for multiple indications including multiple sclerosis, rheumatoid arthritis and nephrotic syndrome
1 November 2021 - Approval re-introduces much needed patient and physician choice into the U.S. repository corticotropin market. ...
Posted by Michael Wonder on 02 Nov 2021
Janssen announces extension of U.S. FDA BLA PDUFA date for BCMA CAR-T ciltacabtagene autoleucel
1 November 2021 - Janssen announced today the U.S. FDA has extended the Prescription Drug User Fee Act date to ...
Posted by Michael Wonder on 02 Nov 2021
Incyte announces acceptance of NDA for parsaclisib for three types of relapsed or refractory non-Hodgkin lymphomas
1 November 2021 - Priority review granted to NDA for relapsed or refractory marginal zone lymphoma and mantle cell lymphoma. ...
Posted by Michael Wonder on 01 Nov 2021
TGA recognises two more COVID-19 vaccines not registered in Australia but used widely internationally
1 November 2021 - Today, the TGA determined that Covaxin (manufactured by Bharat Biotech, India) and BBIBP-CorV (manufactured by Sinopharm, China) ...
Posted by Michael Wonder on 31 Oct 2021
FDA authorises Pfizer-BioNTech COVID-19 vaccine for emergency use in children 5 through 11 years of age
29 October 2021 - Today, the U.S. FDA authorised the emergency use of the Pfizer-BioNTech COVID-19 Vaccine for the prevention of ...
Posted by Michael Wonder on 31 Oct 2021
U.S. Food and Drug Administration Approves Vuity (pilocarpine hydrochloride 1.25% ophthalmic solution) the first and only eye drop to treat presbyopia (age related blurry near vision)
29 October 2021 - Presbyopia, or age related blurry near vision, is a common, progressive condition that reduces the eye's ability ...
Posted by Michael Wonder on 30 Oct 2021
FDA approves Novartis Scemblix (asciminib) with novel mechanism of action for the treatment of chronic myeloid leukemia
29 October 2021 - Scemblix provides much-needed and long-awaited new option for patients with chronic myeloid leukaemia who suffer with intolerance ...
Posted by Michael Wonder on 29 Oct 2021
Kite's Tecartus (brexucabtagene autoleucel) authorised by Health Canada for the treatment of relapsed or refractory mantle cell lymphoma
28 October 2021 - Tecartus is first CAR T therapy in mantle cell lymphoma and Kite becomes the first company ...
Posted by Michael Wonder on 29 Oct 2021
Incyte announces the validation of the European marketing authorisation application for ruxolitinib cream in vitiligo
28 October 2021 - The marketing authorisation application seeks approval of ruxolitinib cream for the treatment of adolescent and adult patients ...