Blog
RSS FeedPosted by Michael Wonder on 22 Jun 2019
FDA approves Botox (onabotulinumtoxinA) for paediatric patients with upper limb spasticity
21 June 2019 - Approval marks 10th Botox therapeutic indication in its 30th anniversary year. ...
Posted by Michael Wonder on 22 Jun 2019
FDA approves new treatment for hypoactive sexual desire disorder in pre-menopausal women
21 June 2019 - The U.S. FDA today approved Vyleesi (bremelanotide) to treat acquired, generalised hypoactive sexual desire disorder in pre-menopausal ...
Posted by Michael Wonder on 21 Jun 2019
FDA expands approval of treatment for cystic fibrosis to include patients ages 6 and older
21 June 2019 - The U.S. FDA today expanded the indication for Symdeko (a combination of tezacaftor/ivacaftor) tablets for treatment of ...
Posted by Michael Wonder on 18 Jun 2019
FDA approves Merck’s Keytruda (pembrolizumab) as monotherapy for patients with metastatic small cell lung cancer with disease progression on or after platinum-based chemotherapy and at least one other prior line of therapy
18 June 2019 - Marks first approval for Keytruda in small cell lung cancer. ...
Posted by Michael Wonder on 17 Jun 2019
FDA approves new treatment for paediatric patients with type 2 diabetes
17 June 2019 - The U.S. Food and Drug Administration today approved Victoza (liraglutide) injection for treatment of paediatric patients 10 ...
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 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
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
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 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 03 Jun 2019
FDA approves new treatment for hospital-acquired and ventilator-associated bacterial pneumonia
3 June 2019 - The U.S. FDA today approved a new indication for the previously FDA approved drug, Zerbaxa (ceftolozane and ...
Posted by Michael Wonder on 31 May 2019
U.S. FDA approves supplemental new drug application adding overall survival data for Xospata (gilteritinib)
30 May 2019 - Phase 3 ADMIRAL trial showed patients treated with Xospate demonstrated longer overall survival than those who ...