Blog
RSS FeedPosted by Michael Wonder on 30 Dec 2021
Janssen submits biologics license application to U.S. FDA seeking approval of teclistamab for the treatment of patients with relapsed or refractory multiple myeloma
29 December 2021 - Janssen announced today the submission of a biologics license application to the U.S. FDA seeking approval ...
Posted by Michael Wonder on 26 Dec 2021
Takeda receives complete response letter from the U.S. FDA for TAK-721
21 December 2021 - Takeda today announced that it has received a complete response letter from the U.S. FDA in ...
Posted by Michael Wonder on 23 Dec 2021
Allarity Therapeutics submits new drug application to the U.S. FDA for dovitinib for third-line treatment of renal cell carcinoma
22 December 2021 - New drug application is supported by Allarity’s previously-filed pre-market approval submission to the FDA for the ...
Posted by Michael Wonder on 22 Dec 2021
Ultomiris regulatory submission accepted under FDA priority review in the US for adults with generalised myasthenia gravis
21 December 2021 - Submission based on positive Phase 3 trial in which Ultomiris significantly improved functional activities as measured ...
Posted by Michael Wonder on 21 Dec 2021
Sandoz submits biologics license application for proposed biosimilar trastuzumab to US FDA
20 December 2021 - Biologics license application is supported by analytical, pre-clinical and clinical data, proposed biosimilar trastuzumab developed by EirGenix. ...
Posted by Michael Wonder on 18 Dec 2021
Pfizer and BioNTech submit supplemental biologics license application for U.S. FDA approval of Comirnaty in adolescents 12 through 15 years of age
16 December 2021 - Pfizer and BioNTech today announced they have submitted a supplemental biologics license application to the U.S. ...
Posted by Michael Wonder on 18 Dec 2021
bluebird bio announces FDA priority review of biologics license application for eli-cel gene therapy for cerebral adrenoleukodystrophy in patients without a matched sibling donor
17 December 2021 - If approved, eli-cel will be the first and only gene therapy for the treatment of cerebral adrenoleukodystrophy, ...
Posted by Michael Wonder on 16 Dec 2021
Verrica Pharmaceuticals announces acceptance by FDA of NDA resubmission for VP-102 for the treatment of molluscum contagiosum
15 December 2021 - Verrica Pharmaceuticals today announced that the U.S. FDA acknowledged that Verrica’s resubmitted new drug application for VP-102 ...
Posted by Michael Wonder on 15 Dec 2021
Sapience Therapeutics receives FDA fast track designation for ST101 for advanced cutaneous melanoma
15 December 2021 - Sapience Therapeutics announced today that the U.S. FDA has granted fast track designation to its lead program, ...
Posted by Michael Wonder on 15 Dec 2021
U.S. FDA grants priority review for spesolimab for the treatment of flares in patients with generalised pustular psoriasis, a rare, life-threatening skin disease
15 December 2021 - Additionally, FDA granted breakthrough therapy designation for spesolimab in the treatment of generalised pustular psoriasis flares. ...
Posted by Michael Wonder on 15 Dec 2021
Alnylam submits regulatory applications to the U.S. FDA and EMA to support label expansion for Oxlumo for the treatment of advanced primary hyperoxaluria type 1
14 December 2021 - Findings from the ILLUMINATE-C Phase 3 study showed substantial reductions in plasma oxalate in PH1 patients with ...
Posted by Michael Wonder on 15 Dec 2021
Incyte announces acceptance and priority review of sNDA for ruxolitinib cream (Opzelura) as a treatment for patients with vitiligo
14 December 2021 - Incyte today announced that the U.S. FDA has accepted for priority review the supplemental new drug application ...
Posted by Michael Wonder on 14 Dec 2021
TG Therapeutics announces FDA acceptance of biologics license application for ublituximab as a treatment for patients with relapsing forms of multiple sclerosis
14 December 2021 - Prescription Drug User Fee Act goal date of 28 September 2022. ...
Posted by Michael Wonder on 08 Dec 2021
Pfizer will submit full data on Covid treatment pill to the FDA in a few days, CEO says
8 December 2021 - Pfizer CEO Albert Bourla said he’s confident the full results from the clinical trials will show that ...
Posted by Michael Wonder on 08 Dec 2021
Fortress Biotech, Cyprium Therapeutics and Sentynl Therapeutics announce the initiation of rolling submission of a new drug application for CUTX-101, copper histidinate, for treatment of Menkes disease
7 December 2021 - Cyprium Therapeutics with support from its licensing partner Sentynl Therapeutics today announced the initiation of a ...