Blog
RSS FeedPosted by Michael Wonder on 16 Jun 2020
Advancing structured decision‐making in drug regulation at the FDA and EMA
11 June 2020 - FDA’s recent benefit‐risk framework was developed for improving the clarity and consistency in communicating the reasoning behind ...
Posted 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
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
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
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 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 ...
Posted by Michael Wonder on 13 Jun 2020
ZZ Biotech announces FDA fast track designation for stroke program
12 June 2020 - ZZ Biotech today announced that the US FDA has designated the investigation of the company’s experimental drug ...
Posted by Michael Wonder on 12 Jun 2020
FDA approves drug to treat infants and children with HIV
12 June 2020 - Today, the U.S. Food and Drug Administration approved Tivicay (dolutegravir) tablets and Tivicay PD (dolutegravir) tablets for ...
Posted by Michael Wonder on 12 Jun 2020
Mylan and Biocon announce U.S. FDA approval of Semglee (insulin glargine injection)
11 June 2020 - FDA approval marks a significant milestone to help increase access and affordability of insulin for the millions ...