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RSS FeedPosted 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
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 ...
Posted by Michael Wonder on 17 Apr 2023
Candel Therapeutics receives FDA fast track designation for CAN-2409 in non-small-cell lung cancer
17 April 2023 - Fast track designation has the potential to facilitate the development and expedite the US FDA review of ...
Posted by Michael Wonder on 17 Apr 2023
IntelGenx announces FDA approval of Rizafilm for the treatment of acute migraine
17 April 2023 - Partner Gensco Pharma preparing to commercially launch Rizafilm across the United States as soon as is practicable. ...
Posted by Michael Wonder on 17 Apr 2023
OTC naloxone is a baby step toward making the life-saving medication accessible
17 April 2023 - In an attempt to make naloxone more accessible amid the massive human toll of the opioid crisis, ...
Posted by Michael Wonder on 16 Apr 2023
Horizon Therapeutics announces FDA approval of an update to the indication language for Tepezza (teprotumumab-trbw) to specify its use in thyroid eye disease patients regardless of disease activity or duration
14 April 2023 - Updated indication language reinforces the importance of unrestricted access for patients across full spectrum of thyroid ...
Posted by Michael Wonder on 14 Apr 2023
Alvotech provides regulatory update on AVT02 biologics license application
13 April 2023 - Alvotech announced today that the US FDA has issued a complete response letter for Alvotech’s biologics license ...
Posted by Michael Wonder on 13 Apr 2023
U.S. FDA issues complete response letter for mirikizumab
13 April 2023 - Eli Lilly announced the US FDA has issued a complete response letter for the mirikizumab biologic license ...
Posted by Michael Wonder on 13 Apr 2023
FDA accepts application for Merck’s Keytruda (pembrolizumab) plus chemotherapy as first-line treatment for locally advanced unresectable or metastatic gastric or gastro-esophageal junction adenocarcinoma
13 April 2023 - Acceptance based on results from the Phase 3 KEYNOTE-859 trial, which showed significant overall survival benefit ...
Posted by Michael Wonder on 13 Apr 2023
Blocking FDA approval of abortion pill could stifle innovation in the biopharma industry, experts say
13 April 2023 - If courts affirm US District Judge Matthew Kacsmaryk’s decision to suspend the FDA’s approval, it could make ...