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RSS FeedPosted by Michael Wonder on 07 Apr 2022
BeiGene announces European Medicines Agency acceptance of marketing authorisation applications for tislelizumab for the treatment of patients with ESCC and NSCLC
6 April 2022 - First European submissions for BeiGene’s anti PD-1 antibody licensed to Novartis for North America, Europe and ...
Posted by Michael Wonder on 06 Apr 2022
Some hoped FDA approval of Pfizer's COVID vaccine would convince unvaccinated Americans. It didn't, study finds.
6 April 2022 - After the Food and Drug Administration approved Pfizer-BioNTech’s COVID-19 vaccine in August, public health experts were ...
Posted by Michael Wonder on 06 Apr 2022
U.S. FDA aims to decide on strain selection for COVID boosters by June
6 April 2022 - The U.S. FDA said it is aiming to come up with a decision on coronavirus strain ...
Posted by Michael Wonder on 06 Apr 2022
BioXcel Therapeutics announces FDA approval of Igalmi (dexmedetomidine) sublingual film for acute treatment of agitation associated with schizophrenia or bipolar I or II disorder in adults
6 April 2022 - U.S. commercial launch planned for Q2 2022. ...
Posted by Michael Wonder on 06 Apr 2022
ECDC and EMA issue advice on fourth doses of mRNA COVID-19 vaccines
6 April 2022 - The European Centre for Disease Prevention and Control and EMA’s COVID-19 task force have concluded that ...
Posted by Michael Wonder on 06 Apr 2022
Dialectic Therapeutics announces DT2216 has received fast track designation from the FDA for adult patients with relapsed or refractory peripheral and cutaneous T-cell lymphoma
5 April 2022 - Dialectic Therapeutics today announced that the U.S. FDA has granted fast track designation to DT2216 for adult ...
Posted by Michael Wonder on 06 Apr 2022
Bristol Myers Squibb receives European Commission approval for Opdivo (nivolumab) with chemotherapy as first-line treatment for patients with unresectable advanced, recurrent or metastatic oesophageal squamous cell carcinoma with tumour cell PD-L1 expression ≥ 1%
5 April 2022 - Opdivo with chemotherapy demonstrated statistically significant and clinically meaningful improvement in overall survival compared to chemotherapy alone ...
Posted by Michael Wonder on 06 Apr 2022
FDA approves Novartis Vijoice (alpelisib) as first and only treatment for select patients with PIK3CA related overgrowth spectrum
6 April 2022 - Approval based on real world data from EPIK-P1 study, which showed patients treated with Vijoice experienced reduction ...
Posted by Michael Wonder on 05 Apr 2022
Bristol Myers Squibb receives European Commission approval for Opdivo (nivolumab) plus Yervoy (ipilimumab) as first-line treatment for patients with unresectable advanced, recurrent or metastatic oesophageal squamous cell carcinoma with tumour cell PD-L1 expression ≥ 1%
5 April 2022 - Opdivo plus Yervoy is one of two newly approved Opdivo based treatment regimens to demonstrate superior overall ...
Posted by Michael Wonder on 05 Apr 2022
Bristol Myers Squibb receives European Commission approval for CAR T cell therapy Breyanzi (lisocabtagene maraleucel) for certain forms of relapsed or refractory large B-cell lymphoma
5 April 2022 - Approval of Breyanzi is based on results from TRANSCEND WORLD, and TRANSCEND NHL 001, the largest pivotal ...
Posted by Michael Wonder on 05 Apr 2022
Curium announces FDA approval of a generic version of DaTscan (Ioflupane I 123 injection) in the U.S.
5 April 2022 - Curium announced today that its generic version of DaTscan (Ioflupane I 123 injection) was approved on 30 ...
Posted by Michael Wonder on 05 Apr 2022
FDA updates sotrovimab emergency use authorisation
5 April 2022 - Sotrovimab is no longer authorised to treat COVID-19 in any U.S. region due to increases in ...
Posted by Michael Wonder on 05 Apr 2022
Watchdog urged to probe McKinsey over work with FDA, opioid manufacturers
5 April 2022 - The consulting firm was getting paid by opioid makers while working for the FDA. ...
Posted by Michael Wonder on 05 Apr 2022
Janssen announces Health Canada approval of Rybrevant (amivantamab), the first and only targeted treatment for patients with non-small cell lung cancer with EGFR exon 20 insertion mutations
4 April 2022 - Targeting both cancer driving and resistance mechanism pathways, Rybrevant offers a unique treatment approach for an ...
Posted by Michael Wonder on 05 Apr 2022
European Commission approves Kimmtrak (tebentafusp) for the treatment of unresectable or metastatic uveal melanoma
4 April 2022 - Kimmtrak demonstrated statistically and clinically meaningful overall survival benefit, hazard ratio of 0.51, with median overall ...