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RSS FeedPosted by Michael Wonder on 13 Oct 2021
FDA approves pembrolizumab combination for the first-line treatment of cervical cancer
13 October 2021 - Today, the FDA approved pembrolizumab (Keytruda, Merck) in combination with chemotherapy, with or without bevacizumab, for ...
Posted by Michael Wonder on 13 Oct 2021
EU may consider deal on Merck's COVID pill after approval procedure begins
12 October 2021 - The European Union may consider signing a supply deal with U.S. drugmaker Merck for its experimental ...
Posted by Michael Wonder on 13 Oct 2021
FDA approves abemaciclib with endocrine therapy for early breast cancer
13 October 2021 - On 12 October 2021, the FDA approved abemaciclib (Verzenio, Eli Lilly) with endocrine therapy (tamoxifen or an ...
Posted by Michael Wonder on 13 Oct 2021
Provisional determination granted to Pfizer's COVID-19 vaccine (Comirnaty) - proposed for use in children 5-11 years of age
13 October 2021 - On 12 October 2021, the Therapeutic Goods Administration granted a provisional determination to Pfizer in relation ...
Posted by Michael Wonder on 12 Oct 2021
FDA’s accelerated approval program: is change on the way?
11 October 2021 - The U.S. FDA launched its accelerated approval program in 1992, offering a pathway to bring life saving ...
Posted by Michael Wonder on 12 Oct 2021
When is the Novavax vaccine coming to Australia? Will it be used for booster shots?
13 October 2021 - Australia's vaccination rate is galloping towards 85 per cent, and more than six in 10 Australians ...
Posted by Michael Wonder on 12 Oct 2021
Deciphera announces approval of Qinlock in Switzerland for the treatment of fourth-line gastro-intestinal stromal tumour
12 October 2021 - Seventh approval worldwide for Qinlock and first European approval. ...
Posted by Michael Wonder on 12 Oct 2021
EMA publishes agenda for 11-14 October CHMP meeting
11 October 2021 - The EMA has published a draft agenda for this week's CHMP meeting. ...
Posted by Michael Wonder on 12 Oct 2021
Y-mAbs’ 177Lu-omburtamab-DTPA for the treatment of patients with medulloblastoma granted rare paediatric disease designation by FDA
7 October 2021 - Y-mAbs Therapeutics today announced that the U.S. FDA has granted rare paediatric disease designation for the Company’s ...
Posted by Michael Wonder on 12 Oct 2021
EMA ends rolling review of CVnCoV COVID-19 vaccine following withdrawal by CureVac
13 October 2021 - The EMA has ended the rolling review of CVnCoV, CureVac AG’s COVID-19 vaccine, after the company ...
Posted by Michael Wonder on 12 Oct 2021
GenSight Biologics announces FDA grant of fast track designation for optogenetic therapy GS030 as treatment for retinitis pigmentosa
12 October 2021 - GenSight Biologics today announced that the U.S. FDA has granted fast track designation to GS030, which combines ...
Posted by Michael Wonder on 12 Oct 2021
Quanterix granted breakthrough device designation from U.S. FDA for blood based pTau 181 assay for Alzheimer’s disease
11 October 2021 - Quanterix Corporation announced today that its Simoa phospho-Tau 181 (pTau-181) blood test has been granted breakthrough ...
Posted by Michael Wonder on 11 Oct 2021
Merck and Ridgeback announce submission of emergency use authorisation application to the U.S. FDA for molnupiravir, an investigational oral anti-viral medicine, for the treatment of mild to moderate COVID-19 in at risk adults
11 October 2021 - Submissions to regulatory agencies worldwide underway. ...
Posted by Michael Wonder on 11 Oct 2021
Ocular Therapeutix announces FDA approval of supplemental new drug application for Dextenza (dexamethasone ophthalmic insert) 0.4 mg for intracanalicular use for the treatment of ocular itching associated with allergic conjunctivitis
11 October 2021 - Approval represents the first primarily office-based indication for Dextenza. ...
Posted by Michael Wonder on 11 Oct 2021
EMA receives application for marketing authorisation for Ronapreve (casirivimab with imdevimab) for treatment and prevention of COVID-19
11 October 2021 - EMA has started evaluating an application for marketing authorisation for the monoclonal antibody combination Ronapreve (casirivimab ...