Blog
RSS FeedPosted by Michael Wonder on 28 Jun 2020
Chiasma announces FDA approval of Mycappsa (octreotide) capsules, the first and only oral somatostatin analogue
26 June 2020 - Mycappsa is indicated for long-term maintenance treatment in acromegaly patients who have responded to and tolerated treatment ...
Posted by Michael Wonder on 26 Jun 2020
Allergan and Molecular Partners receive complete response letter from FDA on biologics license application for abicipar pegol
26 June 2020 - Allergan and Molecular Partners today announced that the U.S. FDA has issued a complete response letter ...
Posted by Michael Wonder on 26 Jun 2020
FDA approves new therapy for Dravet syndrome
25 June 2020 - The U.S. FDA today approved Fintepla (fenfluramine), a Schedule IV controlled substance, for the treatment of seizures ...
Posted by Michael Wonder on 24 Jun 2020
FDA approves pembrolizumab for cutaneous squamous cell carcinoma
24 June 2020 - Today the FDA approved pembrolizumab (Keytruda, Merck & Co) for patients with recurrent or metastatic cutaneous ...
Posted by Michael Wonder on 22 Jun 2020
FDA approves selinexor for relapsed/refractory diffuse large B-cell lymphoma
22 June 2020 - Today the Food and Drug Administration granted accelerated approval to selinexor (Xpovio, Karyopharm Therapeutics) for adult ...
Posted by Michael Wonder on 21 Jun 2020
FDA approves new Dupixent (dupilumab) pre-filled pen designed to support more convenient self-administration
19 June 2020 - 300 mg pre-filled pen expected to be available third quarter of 2020. ...
Posted by Michael Wonder on 20 Jun 2020
Nabriva Therapeutics receives complete response letter from FDA on NDA for Contepo (fosfomycin) for injection
19 June 2020 - Agency cited travel restrictions and inability to conduct onsite inspections to resolve observations at manufacturing partner facilities. ...
Posted by Michael Wonder on 20 Jun 2020
FDA approves Evoke’s Gimoti
19 June 2020 - Commercial partner Eversana prepares for Gimoti launch. ...
Posted by Michael Wonder on 18 Jun 2020
FDA granted accelerated approval to tazemetostat for follicular lymphoma
18 June 2020 - Today the Food and Drug Administration granted accelerated approval to tazemetostat (Tazverik, Epizyme), an EZH2 inhibitor, ...
Posted by Michael Wonder on 18 Jun 2020
FDA approves first therapy for rare disease that causes low phosphate blood levels, bone softening
18 June 2020 - Today, the U.S. Food and Drug Administration approved Crysvita (burosumab-twza) injection to treat patients age two and ...
Posted by Michael Wonder on 17 Jun 2020
FDA approves pembrolizumab for adults and children with TMB-H solid tumours
17 June 2020 - On 16 June 2020, the FDA granted accelerated approval to pembrolizumab (Keytruda, Merck) for the treatment ...
Posted by Michael Wonder on 17 Jun 2020
Novartis Cosentyx receives FDA approval for new indication to treat active non-radiographic axial spondyloarthritis
17 June 2020 - FDA approval for Cosentyx is based on the Phase III PREVENT trial, demonstrating efficacy in active ...
Posted by Michael Wonder on 16 Jun 2020
FDA approves first treatment for adult onset Still’s disease, a severe and rare disease
16 June 2020 - The U.S. Food and Drug Administration today approved Ilaris (canakinumab) injection for the treatment of active Still’s ...
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
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 ...