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RSS FeedPosted by Michael Wonder on 18 May 2021
U.S. FDA accepts regulatory submission for sintilimab in combination with pemetrexed and platinum chemotherapy for the first-line treatment of people with non-squamous non-small cell lung cancer
18 May 2021 - Innovent Biologics and Eli Lilly today jointly announced that the U.S. FDA accepted for review a biologics ...
Posted by Michael Wonder on 17 May 2021
Biogen hopes Alzheimer’s drug mired in controversy earns FDA nod
13 May 2021 - After scores of failures, regulators are set to rule on aducanumab, which promises to slow dementia. ...
Posted by Michael Wonder on 17 May 2021
Adamis Pharmaceuticals resubmits Zimhi new drug application to FDA for the treatment of opioid overdose
17 May 2021 - Adamis Pharmaceuticals today announced that the new drug application was resubmitted to the U.S. FDA for ...
Posted by Michael Wonder on 14 May 2021
PharmaEssentia resubmits application to the U.S. FDA for ropeginterferon alfa-2b-njft to treat polycythemia vera
14 May 2021 - PharmaEssentia today announced the resubmission of its biologics license application to the U.S. FDA, seeking approval for ...
Posted by Michael Wonder on 13 May 2021
Strongbridge Biopharma announces U.S. FDA filing acceptance of new drug application for Recorlev (levoketoconazole) for the treatment of endogenous Cushing’s syndrome
13 May 2021 - FDA Sets Prescription Drug User Fee Act target action date of 1 January 2022. ...
Posted by Michael Wonder on 12 May 2021
Liquidia resubmits new drug application for LIQ861 (treprostinil) inhalation powder for the treatment of pulmonary arterial hypertension
10 May 2021 - Liquidia Corporation announced today that on 7 May 2021, it resubmitted its new drug application for LIQ861 ...
Posted by Michael Wonder on 10 May 2021
Amgen announces tezepelumab biologics license application submitted to U.S. FDA
10 May 2021 - Potential first in class medicine blocking TSLP, an epithelial sytokine. ...
Posted by Michael Wonder on 08 May 2021
AstraZeneca weighs seeking full U.S. approval for COVID-19 shot, skipping emergency use application
7 May 2021 - British drugmaker faces challenges gathering data; may wait to apply for full approval by the FDA, which ...
Posted by Michael Wonder on 07 May 2021
Pfizer and BioNTech initiate rolling submission of biologics license application for U.S. FDA approval of their COVID-19 vaccine
7 May 2021 - - Pfizer and BioNTech today announced the initiation of a biologics license application with the U.S. FDA ...
Posted by Michael Wonder on 05 May 2021
FDA accepts Amgen's supplemental new drug application for Otezla (apremilast) for adults with mild to moderate plaque psoriasis
5 May 2021 - Acceptance based on data from Phase 3 ADVANCE trial, demonstrating clinically meaningful improvements through week 32. ...
Posted by Michael Wonder on 05 May 2021
US FDA accepts GC Pharma’s biologics license application for immunoglobulin 'GC5107'
5 May 2021 - A significant milestone towards entering the world's largest plasma product marketplace. ...
Posted by Michael Wonder on 05 May 2021
Servier announces FDA filing acceptance and priority review for Tibsovo (ivosidenib) in IDH1 mutated cholangiocarcinoma
5 May 2021 - Servier Pharmaceuticals today announced that the U.S. FDA has accepted the company's supplemental new drug application for ...
Posted by Michael Wonder on 04 May 2021
Pfizer will file for full FDA approval by end of May
4 May 2021 - Pfizer and BioNTech, the manufacturers of one of the three authorised COVID-19 vaccines in the U.S., plan ...
Posted by Michael Wonder on 04 May 2021
ViiV Healthcare initiates rolling submission of new drug application with US FDA for long-acting cabotegravir for prevention of HIV
4 May 2021 - If approved, cabotegravir would be the first, long-acting therapy for HIV PrEP. ...
Posted by Michael Wonder on 04 May 2021
SIGA announces new drug application filing with FDA for intravenous formulation of TPOXX
4 May 2021 - Important for patients who cannot swallow oral capsules. ...