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RSS FeedPosted by Michael Wonder on 17 Aug 2021
FDA grants accelerated approval of Jemperli (dostarlimab-gxly) for dMMR recurrent or advanced solid tumours
17 August 2021 - Second FDA approval of PD-1 antagonist antibody under clinical development for solid tumours in collaboration with GSK. ...
Posted by Michael Wonder on 17 Aug 2021
Helius Medical Technologies announces FDA breakthrough device designation for the treatment of dynamic gait and balance deficits following a stroke
17 August 2021 - Helius Medical Technologies today announced that it has received breakthrough designation from the U.S. FDA for its ...
Posted by Michael Wonder on 16 Aug 2021
Abbott's Amplatzer Amulet device approved by FDA to treat people with atrial fibrillation at risk of stroke
16 August 2021 - Amulet is the first and only minimally invasive treatment option to offer immediate closure of the left ...
Posted by Michael Wonder on 16 Aug 2021
Merck Canada initiates rolling submission to Health Canada for molnupiravir, an investigational oral therapeutic agent for the treatment of COVID-19
13 August 2021 - Merck today announced the initiation of a rolling submission to Health Canada for molnupiravir, an investigational twice ...
Posted by Michael Wonder on 16 Aug 2021
Edgewise receives U.S. FDA fast track designation for EDG-5506 for the treatment of individuals with Becker muscular dystrophy
16 August 2021 - EDG-5506, a drug candidate designed to arrest muscle fibre breakdown in Becker and Duchenne muscular dystrophy, continues to ...
Posted by Michael Wonder on 16 Aug 2021
Carrick Therapeutics receives FDA fast track designations for two samuraciclib combinations for the treatment of HR+, HER2- advanced breast cancer and locally advanced or metastatic triple negative breast cancer
16 August 2021 - Carrick Therapeutics today announced that the U.S. FDA has granted Fast Track designations to samuraciclib in combination ...
Posted by Michael Wonder on 16 Aug 2021
EMA starts evaluating use of RoActemra in hospitalised adults with severe COVID-19
16 August 2021 - EMA has started evaluating the anti-inflammatory medicine RoActemra (tocilizumab) to extend its use to include treatment ...
Posted by Michael Wonder on 16 Aug 2021
Pfizer and BioNTech announce submission of initial data to U.S. FDA to support booster dose of COVID-19 vaccine
16 August 2021 - Phase 1 safety and immunogenicity data in individuals who received a third dose of the Pfizer-BioNTech vaccine ...
Posted by Michael Wonder on 16 Aug 2021
FDA approves Lyumjev (insulin lispro-aabc injection) 100 units/mL for use in insulin pumps
16 August 2021 - U.S. approval of pump use for Lilly's novel insulin is latest development designed to help people ...
Posted by Michael Wonder on 16 Aug 2021
Artificial intelligence in medicine regulation
16 August 2021 - The International Coalition of Medicines Regulatory Authorities sets out recommendations to help regulators to address the ...
Posted by Michael Wonder on 16 Aug 2021
InxMed's IN10018 receives U.S. FDA fast track designation for the treatment of platinum-resistant ovarian cancer
16 August 2021 - InxMed announced today the U.S. FDA has granted fast track designation to IN10018 for the treatment of ...
Posted by Michael Wonder on 16 Aug 2021
U.S. FDA approves Ticovac, Pfizer's tick borne encephalitis vaccine
13 August 2021 - Ticovac may help reduce the risk of tick-borne encephalitis for people traveling to endemic areas, potentially including ...
Posted by Michael Wonder on 15 Aug 2021
Coronavirus (COVID-19) update: FDA authorises additional vaccine dose for certain immunocompromised individuals
12 August 2021 - Other fully vaccinated individuals do not need an additional vaccine dose right now. ...
Posted by Michael Wonder on 14 Aug 2021
Sesen Bio receives complete response letter from FDA for Vicineum (oportuzumab monatox-qqrs)
Sesen Bio today announced that it received a complete response letter from the U.S. FDA regarding its biologics license application ...
Posted by Michael Wonder on 14 Aug 2021
Ipsen announces withdrawal of palovarotene NDA, confirming intention to resubmit following additional data analyses
13 August 2021 - This follows ongoing dialogue with the U.S. FDA regarding the palovarotene NDA review, initiated in May ...