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RSS FeedPosted by Michael Wonder on 21 Nov 2020
Pfizer and BioNTech to submit emergency use authorisation request today to the U.S. FDA for COVID-19 vaccine
20 November 2020 - In addition to today’s submission to the FDA, the companies have already initiated rolling submissions across the ...
Posted by Michael Wonder on 20 Nov 2020
Imfinzi approved in the US for less-frequent, fixed-dose use
20 November 2020 - Four-week dosing now approved in all Imfinzi indications, reducing medical visits and improving patient convenience ...
Posted by Michael Wonder on 20 Nov 2020
FDA grants breakthrough designation to 4D Path for novel cancer diagnostic solution
18 November 2020 - 4D Path today announced that the U.S. FDA has granted the company breakthrough device designation for ...
Posted by Michael Wonder on 20 Nov 2020
PTC Therapeutics announces key regulatory designations for PTC596 to advance treatment of two rare oncology indications
18 November 2020 - PTC Therapeutics today announced that the United States FDA has granted PTC596 both orphan drug designation and ...
Posted by Michael Wonder on 20 Nov 2020
Lumicell granted fast track designation approval by the FDA for breast cancer treatment
18 November 2020 - Fast track designation augments previously granted breakthrough device designation. ...
Posted by Michael Wonder on 20 Nov 2020
FDA authorises drug combination for treatment of COVID-19
19 November 2020 - Today, the U.S. FDA issued an emergency use authorisation for the drug baricitinib, in combination with ...
Posted by Michael Wonder on 19 Nov 2020
Lantheus announces FDA approval of Definity room temperature
18 November 2020 - Lantheus today announced the U.S. FDA has approved the supplemental new drug application for Definity Room ...
Posted by Michael Wonder on 19 Nov 2020
Alvotech announces that the U.S. FDA and EMA have accepted regulatory submissions for AVT02, a proposed biosimilar to Humira (adalimumab)
19 November 2020 - Alvotech is developing AVT02 as a proposed biosimilar to Humira (adalimumab) with high concentration (100 mg/mL) dosage ...
Posted by Michael Wonder on 19 Nov 2020
Omeros submits its biologics license application to U.S. FDA for narsoplimab in HSCT-TMA
18 November 2020 - Omeros Corporation announced that it has completed the rolling submission of its biologics license application to ...
Posted by Michael Wonder on 18 Nov 2020
Pfizer will seek regulatory review ‘within days’ for its vaccine
18 November 2020 - The coronavirus vaccine being developed by Pfizer and German biotechnology firm BioNTech is 95% effective at ...
Posted by Michael Wonder on 18 Nov 2020
The vaccines will probably work. Making them fast will be the hard part.
18 November 2020 - Front-runners in the coronavirus vaccine race won’t make nearly as many doses this year as were predicted, ...
Posted by Michael Wonder on 18 Nov 2020
Samsung Bioepis and Biogen announce FDA filing acceptance of SB11, a proposed biosimilar referencing Lucentis (ranibizumab)
18 November 2020 - Samsung Bioepis and Biogen today announced that the U.S. FDA has accepted for review the biologics license ...
Posted by Michael Wonder on 18 Nov 2020
Rilzabrutinib granted FDA fast track designation for treatment of immune thrombocytopenia
18 November 2020 - Phase 3 trial initiated to evaluate rilzabrutinib, the potential first Bruton’s tyrosine kinase inhibitor for the treatment ...
Posted by Michael Wonder on 18 Nov 2020
FDA grants priority review for avalglucosidase alfa, a potential new therapy for Pompe disease
18 November 2020 - Regulatory submission based on positive data from two trials in patients with late-onset and infantile-onset Pompe disease, ...
Posted by Michael Wonder on 18 Nov 2020
Alkermes receives FDA complete response letter related to ALKS 3831 manufacturing records review
17 November 2020 - No clinical efficacy or safety issues raised and no further studies required by FDA to support approval. ...