Blog
RSS FeedPosted by Michael Wonder on 14 Jun 2019
Ensuring innovation and competition for biologics leads to more timely products for patients
13 June 2019 - Today, the FDA approved the agency’s 20th biosimilar product, Kanjinti (trastuzumab-anns), for the treatment of patients with ...
Posted by Michael Wonder on 13 Jun 2019
Amgen wins FDA approval for Kanjinti injection for treatment of breast cancer, gastro-esophageal junction adenocarcinoma
13 June 2019 - U.S. FDA says Kanjinti (trastuzumab-anns) is biosimilar to Herceptin (trastuzumab). ...
Posted by Michael Wonder on 13 Jun 2019
FDA grants priority review to Genentech’s Rituxan (rituximab) in children with two rare blood vessel disorders
12 June 2019 - If approved, this would be the first paediatric indication for Rituxan. ...
Posted by Michael Wonder on 12 Jun 2019
Catalyst Pharma sues FDA over approval of cheaper rival drug
12 June 2019 - Catalyst Pharmaceuticals Inc, which has come under fire for the high price tag on its rare ...
Posted by Michael Wonder on 11 Jun 2019
Should the FDA disclose new filings for drugs, biologics and biosimilars?
11 June 2019 - In 2010, the FDA issued draft recommendations on increasing the transparency of the FDA’s processes and ...
Posted by Michael Wonder on 11 Jun 2019
Jacobus prices its rare disease drug at half of what Catalyst charges, but will doctors prescribe it?
10 June 2019 - After weeks of anticipation, Jacobus Pharmaceutical, a small, family-run drug maker, has priced its rare disease ...
Posted by Michael Wonder on 11 Jun 2019
FDA approves two new indications for Merck’s Keytruda (pembrolizumab)
11 June 2019 - Keytruda now approved for first-line treatment of patients with metastatic or with unresectable, recurrent head and neck ...
Posted by Michael Wonder on 10 Jun 2019
The $2.1 million question: what are the medical, ethical implications of the world's priciest drug?
10 June 2019 - With last month’s FDA approval, Zolgensma became the world’s most expensive medication. ...
Posted 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 ...