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RSS FeedPosted by Michael Wonder on 22 Apr 2023
Canada says it could offer access to mifepristone if the abortion drug is banned in the US
22 April 2023 - A Canadian health official said on Friday Americans could access an abortion drug up north if ...
Posted by Michael Wonder on 22 Apr 2023
Mifepristone: US Supreme Court preserves abortion drug access
22 April 2023 - The US Supreme Court has preserved access to a commonly used abortion pill, ruling the drug ...
Posted by Michael Wonder on 21 Apr 2023
Quizartinib NDA review for patients with newly diagnosed FLT3-ITD positive AML extended by FDA
20 April 2023 - Daiichi Sankyo today announced that the US FDA has extended the review period for the new ...
Posted by Michael Wonder on 20 Apr 2023
FDA approval processes for therapeutic drugs must be improved
18 April 2023 - The FDA’s glacial pace at reviewing and approving new drugs has an enormous opportunity cost for ...
Posted by Michael Wonder on 20 Apr 2023
Ardelyx resubmits new drug application to US FDA for Xphozah (tenapanor)
18 April 2023 - Company expects to receive goal review date in mid May. ...
Posted by Michael Wonder on 19 Apr 2023
FDA approves Genentech's Polivy in combination with R-CHP for people with certain types of previously untreated diffuse large B-cell lymphoma
19 April 2023 - Polarix trial showed the Polivy combination reduced the risk of disease progression, relapse or death by 27% ...
Posted by Michael Wonder on 19 Apr 2023
Abortion pill maker sues FDA to preserve access
19 April 2023 - The lawsuit from GenBioPro, which makes the generic version of the drug, comes as SCOTUS action looms. ...
Posted by Michael Wonder on 19 Apr 2023
SAB Biotherapeutics announces US FDA grants breakthrough therapy designation to SAB-176 influenza immunotherapy
18 April 2023 - SAB-176 has now received both breakthrough and fast track designations from FDA – signifying its potential to ...
Posted by Michael Wonder on 19 Apr 2023
US FDA accepts for priority review Taiho Oncology's supplemental new drug application for the use of trifluridine/tipiracil (Lonsurf) in combination with bevacizumab for refractory metastatic colorectal cancer
18 April 2023 - The supplemental new drug application is supported by data from the Phase 3 SUNLIGHT clinical trial, the ...
Posted by Michael Wonder on 19 Apr 2023
Madrigal receives breakthrough therapy designation from FDA for resmetirom
18 April 2023 - Madrigal Pharmaceuticals today announced that resmetirom has received breakthrough therapy designation from the US FDA for the ...
Posted by Michael Wonder on 18 Apr 2023
CSL Behring receives FDA approval for Hizentra (immune globulin subcutaneous [human] 20% liquid) 50 mL pre-filled syringe
18 April 2023 - Hizentra is the first and only immune globulin available in pre-filled syringes, offering those living with ...
Posted by Michael Wonder on 18 Apr 2023
Why are there drug shortages?
18 April 2023 - What if you are hospitalised and the drug needed to save your life isn’t available? That ...
Posted by Michael Wonder on 18 Apr 2023
Hugel hit with another complete response letter from the FDA
18 April 2023 - Hugel's much anticipated US launch of its botulinum toxin product, Letybo, has experienced yet another setback. ...
Posted by Michael Wonder on 18 Apr 2023
US FDA approves Qulipta (atogepant) for adults with chronic migraine
17 April 2023 - Qulipta now the first and only oral CGRP receptor antagonist approved to prevent migraine across frequencies, including ...
Posted by Michael Wonder on 17 Apr 2023
Agenus receives fast track designation for botensilimab and balstilimab in colorectal cancer
17 April 2023 - Agenus has been granted fast track designation from the US FDA for the investigation of the combination ...