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RSS FeedPosted by Michael Wonder on 16 Jun 2020
FDA approves gemtuzumab ozogamicin for CD33-positive AML in paediatric patients
16 June 2020 - Today the FDA extended the indication of gemtuzumab ozogamicin (Mylotarg, Wyeth Pharmaceuticals) for newly-diagnosed CD33-positive acute ...
Posted by Michael Wonder on 16 Jun 2020
First drug proves able to improve survival from COVID-19, trial shows
17 June 2020 - A low-cost, widely used anti-inflammatory drug has improved survival in patients with COVID-19, scientists say, the ...
Posted by Michael Wonder on 16 Jun 2020
Supreme Court will not hear generic drug price fixing discovery dispute
16 June 2020 - The U.S. Supreme Court on Monday declined to hear generic drug makers’ challenge to a court ...
Posted by Michael Wonder on 16 Jun 2020
FDA approves Lyumjev (insulin lispro-aabc injection), Lilly's new rapid-acting insulin
15 June 2020 - The U.S. FDA has approved Lyumjev (insulin lispro-aabc injection, 100 units/mL and 200 units/mL), Eli Lilly and ...
Posted by Michael Wonder on 16 Jun 2020
Acadia Pharmaceuticals submits supplemental new drug application to U.S. FDA for Nuplazid (pimavanserin) for the treatment of hallucinations and delusions associated with dementia-related psychosis
15 June 2020 - Submission based on positive results from the Phase 3 HARMONY study which showed a statistically significant 2.8 ...
Posted by Michael Wonder on 15 Jun 2020
Sunovion announces Health Canada approval of Kynmobi (apomorphine hydrochloride) soluble film for the treatment of Parkinson's disease OFF episodes
15 June 2020 - First and only sublingual therapy approved for the on-demand treatment of Parkinson’s disease OFF episodes. ...
Posted by Michael Wonder on 15 Jun 2020
FDA permits marketing of first game-based digital therapeutic to improve attention function in children with ADHD
15 June 2020 - Today, the U.S. FDA permitted marketing of the first game-based digital therapeutic device to improve attention function ...
Posted by Michael Wonder on 15 Jun 2020
Jazz Pharmaceuticals announces U.S. FDA accelerated approval of Zepzelca (lurbinectedin) for the treatment of metastatic small cell lung cancer
15 June 2020 - Zepzelca is approved under accelerated approval based on overall response rate and duration of response demonstrated in ...
Posted by Michael Wonder on 15 Jun 2020
Global regulators work towards alignment on policy approaches and regulatory flexibility during COVID-19 – update #4
15 June 2020 - The International Coalition of Medicines Regulatory Authorities convened its regular virtual meeting of regulators from around ...
Posted by Michael Wonder on 15 Jun 2020
COVID-19 update: FDA revokes emergency use authorisation for chloroquine and hydroxychloroquine
15 June 2020 - Today, the U.S. FDA revoked the emergency use authorisation that allowed for chloroquine phosphate and hydroxychloroquine sulphate ...
Posted by Michael Wonder on 15 Jun 2020
Biogen’s FDA application for Alzheimer’s drug drags on
15 June 2020 - Biogen’s filing of aducanumab, an investigational Alzheimer’s drug, for U.S. approval is drifting from its initial ...
Posted by Michael Wonder on 15 Jun 2020
The pandemic claims new victims: prestigious medical journals
14 June 2020 - Two major study retractions in one month have left researchers wondering if the peer review process is ...
Posted by Michael Wonder on 14 Jun 2020
EMA management board backs rolling review fees, COVID-19 transparency measures
12 June 2020 - After its June meeting on Thursday, the EMA’s management board said it has approved a new ...
Posted by Michael Wonder on 13 Jun 2020
FDA approves Merck’s Gardasil 9 for the prevention of certain HPV related head and neck cancers
12 June 2020 - Gardasil (human papillomavirus 9 valent vaccine, recombinant) now approved for the prevention of HPV related cervical, ...
Posted by Michael Wonder on 13 Jun 2020
Antimicrobials benefited from expedited FDA programs more than other drugs
12 June 2020 - Amid concerns over the need for more antimicrobials, a new analysis finds these medicines benefited more ...