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RSS FeedPosted by Michael Wonder on 05 May 2021
BioNTech nearing request for approval of longer lasting version of COVID vaccine
4 May 2021 - BioNTech is working on getting approval for a version of its COVID-19 vaccine which can be ...
Posted by Michael Wonder on 05 May 2021
Pfizer says it will seek clearance in September for its vaccine to be used in children aged 2 to 11
4 May 2021 - Pfizer expects to apply to the FDA in September for emergency authorisation to administer its coronavirus ...
Posted by Michael Wonder on 05 May 2021
Health Canada authorises use of the Pfizer-BioNTech COVID-19 vaccine in children 12 to 15 years of age
5 May 2021 - Today, Health Canada authorised the use of the Pfizer-BioNTech COVID-19 vaccine in children 12 to 15 ...
Posted by Michael Wonder on 05 May 2021
FDA grants accelerated approval to pembrolizumab for HER2 positive gastric cancer
5 May 2021 - Today the FDA granted accelerated approval to pembrolizumab (Keytruda, Merck & Co.) in combination with trastuzumab, ...
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 05 May 2021
Roche’s Tecentriq approved by European Commission as a first-line monotherapy treatment for people with a type of metastatic non-small cell lung cancer
5 May 2021 - This approval marks Tecentriq’s fourth indication in metastatic non-small cell lung cancer and fifth indication in lung ...
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
TGA approves new treatment for aggressive form of prostate cancer
5 May 2021 - The TGA has registered a new medication to treat a particularly aggressive and advanced type of ...
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
Australia's TGA grants approval to first objective concussion diagnostic
4 May 2021 - Oculogica's EyeBOX is the only objective diagnostic cleared by the US FDA and Australia TGA as an ...
Posted by Michael Wonder on 04 May 2021
Micro Medical Solutions receives FDA breakthrough device designation for MicroStent vascular stent
4 May 2021 - Breakthrough designation helps advance treatment options, targeting a significant unmet need in the treatment of critical limb-threatening ischaemia. ...
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. ...
Posted by Michael Wonder on 04 May 2021
EMA starts rolling review of COVID-19 vaccine (Vero Cell) inactivated
4 May 2021 - EMA’s CHMP has started a rolling review of COVID-19 Vaccine (Vero Cell) inactivated, developed by Sinovac ...