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RSS FeedPosted by Michael Wonder on 10 Jun 2019
FDA approves first chemoimmunotherapy regimen for patients with relapsed or refractory diffuse large B-cell lymphoma
10 June 2019 - Today, the U.S. Food and Drug Administration granted accelerated approval to Polivy (polatuzumab vedotin-piiq), in combination with ...
Posted by Michael Wonder on 08 Jun 2019
PTC Therapeutics receives FDA approval for the expansion of the Emflaza (deflazacort) labeling to include patients 2-5 years of age
7 June 2019 - Emflaza is the only approved treatment for all patients two and over living with Duchenne muscular dystrophy. ...
Posted by Michael Wonder on 08 Jun 2019
FDA permits marketing of first medical device for relief of pain associated with irritable bowel syndrome in patients 11-18 years of age
7 June 2019 - The U.S. FDA today permitted marketing of the first medical device to aid in the reduction ...
Posted by Michael Wonder on 08 Jun 2019
FDA OKs new administration options for GSK’s Nucala
7 June 2019 - GlaxoSmithKline’s Nucala (mepolizumab) has gained US FDA approval for two new self-administration options, making the drug ...
Posted by Michael Wonder on 06 Jun 2019
Pfizer denies report it hid possible Alzheimer’s breakthrough
5 June 2019 - Pfizer is fighting back against a report that it hid the potential of a blockbuster drug ...
Posted by Michael Wonder on 06 Jun 2019
FDA's Woodcock defends accelerated approvals and talks of culture shift in clinical trials
5 June 2019 - Over more than three decades at the Food and Drug Administration, Janet Woodcock has seen the ...
Posted by Michael Wonder on 06 Jun 2019
Xeris Pharmaceuticals receives notification of PDUFA date extension for Gvoke
6 June 2019 - Xeris Pharmaceuticals announced today that the U.S. FDA has extended the initial Prescription Drug User Fee ...
Posted by Michael Wonder on 06 Jun 2019
US FDA and EMA accept applications for ozanimod for the treatment of relapsing forms of multiple sclerosis
6 June 2019 - Celgene Corporation today announced that the U.S. FDA has accepted for review the new drug application ...
Posted by Michael Wonder on 06 Jun 2019
Enzyvant announces FDA acceptance of biologics license application and priority review status for RVT-802, a novel investigational tissue-based regenerative therapy for paediatric congenital athymia
5 June 2019 - RVT-802, a one-time therapy, leverages Enzyvant’s T cell generation platform designed to treat profound immunodeficiencies. ...
Posted by Michael Wonder on 06 Jun 2019
Alnylam completes rolling submission of new drug application to U.S. FDA for givosiran for the treatment of acute hepatic porphyria
5 June 2019 - First potential treatment demonstrating substantial reduction in the frequency of porphyria attacks. ...
Posted by Michael Wonder on 05 Jun 2019
Pharma groups combine to promote drug discovery with AI
5 June 2019 - Blockchain system allows companies to share data without revealing commercial secrets. ...
Posted by Michael Wonder on 05 Jun 2019
Sierra announces momelotinib granted FDA fast track designation
5 June 2019 - Fast Track designation highlights the potential for momelotinib to address the significant unmet needs of patients with ...
Posted by Michael Wonder on 05 Jun 2019
Pfizer knew drug may prevent Alzheimer's. Why didn't it tell us?
5 June 2019 - A team of researchers inside Pfizer made a startling find in 2015: the company's blockbuster rheumatoid ...
Posted by Michael Wonder on 04 Jun 2019
FDA approves Lilly’s migraine drug as first ever cluster headache treatment
4 June 2019 - The drug will be priced the same as for migraine on a per milligram basis, but the ...
Posted by Michael Wonder on 04 Jun 2019
Hiding in plain sight: the FDA’s approach to disclosing new drug applications is a disservice to public health
4 June 2019 - Remember in high school when a friend told you a secret and you guarded it assiduously, ...