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RSS FeedPosted by Michael Wonder on 14 Jun 2023
CellCentric receives FDA fast track designation for relapsed refractory multiple myeloma drug
13 June 2023 - CellCentric has announced that the US FDA has granted its novel cancer drug, inobrodib, fast track designation ...
Posted by Michael Wonder on 14 Jun 2023
Ipsen announces US FDA submission acceptance of its supplemental new drug application for Onivyde regimen in first-line metastatic pancreatic ductal adenocarcinoma
14 June 2023 - Supplemental new drug application submission based on the NAPOLI 3 Phase 3 trial. ...
Posted by Michael Wonder on 14 Jun 2023
Eagle Pharmaceuticals receives FDA qualified infectious disease product and fast track designation for CAL02
14 June 2023 - With QIDP, Eagle expects to receive eight or ten years of regulatory exclusivity upon NDA approval. ...
Posted by Michael Wonder on 13 Jun 2023
Eupraxia Pharmaceuticals receives US FDA fast track designation for EP-104IAR in treatment of osteoarthritis
13 June 2023 - Eupraxia Pharmaceuticals today announced that the US FDA has granted fast track designation for the investigation of ...
Posted by Michael Wonder on 13 Jun 2023
US FDA approves Bylvay for patients living with cholestatic pruritus due to Alagille syndrome
13 June 2023 - Immediate US commercial launch and availability for eligible patients. ...
Posted by Michael Wonder on 12 Jun 2023
Phathom Pharmaceuticals announces FDA acceptance of NDA resubmission for erosive GERD
12 June 2023 - PDUFA goal date of 17 November 2023. ...
Posted by Michael Wonder on 12 Jun 2023
FDA approves first treatment for paediatric functional constipation
12 June 2023 - The FDA has approved Linzess (linaclotide) capsules to treat functional constipation in paediatric patients 6 to ...
Posted by Michael Wonder on 12 Jun 2023
Capivasertib in combination with Faslodex granted priority review in the US for patients with advanced hormone receptor positive breast cancer
12 June 2023 - Decision based on CAPItello-291 Phase 3 trial results which showed the combination reduced the risk of ...
Posted by Michael Wonder on 10 Jun 2023
Paediatric drug and other shortages in the age of supply chain disruption
9 June 2023 - The last year witnessed several significant shortages of key medicines and other products for children, including ...
Posted by Michael Wonder on 08 Jun 2023
Novaliq announces FDA approval of Vevye (cyclosporine ophthalmic solution) 0.1% for the treatment of the signs and symptoms of dry eye disease
8 June 2023 - Vevye is the first and only cyclosporine solution indicated for the treatment of signs and symptoms ...
Posted by Michael Wonder on 08 Jun 2023
SAR443579/IPH6101 receives FDA fast track designation in the US for the treatment of haematological malignancies
8 June 2023 - SAR443579, ANKET platform lead asset, is a trifunctional anti-CD123 NKp46×CD16 NK cell engager from a joint research ...
Posted by Michael Wonder on 08 Jun 2023
FDA accepts application for Merck’s Keytruda (pembrolizumab) plus chemotherapy as treatment for advanced or unresectable biliary tract cancer
8 June 2023 - Acceptance based on results from the Phase 3 KEYNOTE-966 trial, which showed a significant overall survival ...
Posted by Michael Wonder on 07 Jun 2023
‘We don’t agree’ on drug pricing policy, FDA chief tells biotech leaders
7 June 2023 - The drug industry has spent the past year speaking against new mechanisms that could limit how ...
Posted by Michael Wonder on 06 Jun 2023
US FDA approves new indication for Merck’s Prevymis (letermovir) for prevention of cytomegalovirus disease in high-risk adult kidney transplant recipients
6 June 2023 - Prevymis now approved for cytomegalovirus (CMV) prophylaxis after kidney transplant in donor CMV seropositive/recipient CMV seronegative ...
Posted by Michael Wonder on 06 Jun 2023
Vyluma announces FDA acceptance of new drug application for NVK002, its novel investigational treatment for paediatric myopia
6 June 2023 – Vyluma announced today that the US FDA has accepted for review the new drug application for ...