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RSS FeedPosted by Michael Wonder on 06 Mar 2024
Camurus announces FDA acceptance of NDA submission for Oclaiz for treatment of acromegaly
5 March 2024 - PDUFA set to 21 October 2024. ...
Posted by Michael Wonder on 05 Mar 2024
Formosa Pharmaceuticals and AimMax Therapeutics receive FDA approval for clobetasol propionate 0.05% ophthalmic suspension for the treatment of post-operative inflammation and pain following ocular surgery
4 March 2024 - Formosa Pharmaceuticals and AimMax Therapeutics announced today that the US FDA has approved clobetasol propionate 0.05% ...
Posted by Michael Wonder on 05 Mar 2024
Ellipses' next generation selective RET inhibitor EP0031/A400 granted fast track designation by US FDA
5 March 2024 - Ellipses Pharma announced today that it has received fast track designation from the US FDA for its ...
Posted by Michael Wonder on 05 Mar 2024
Drug makers send counter offers for US Medicare price negotiations, Biden says
4 March 2024 - The manufacturers of 10 high cost drugs selected for the US Medicare program's first-ever pricing negotiations ...
Posted by Michael Wonder on 05 Mar 2024
Sandoz receives FDA approval for first and only denosumab biosimilars
5 March 2024 - Wyost (denosumab-bddz) and Jubbonti (denosumab-bddz) interchangeable with and approved by FDA for all indications of reference ...
Posted by Michael Wonder on 05 Mar 2024
Zevra Therapeutics provides FDA update on the PDUFA action date for arimoclomol as a treatment for Niemann-Pick disease type C
4 March 2024 - The new PDUFA action date set by the FDA is 21 September 2024. ...
Posted by Michael Wonder on 04 Mar 2024
SpringWorks Therapeutics initiates rolling submission of new drug application to the FDA for mirdametinib for the treatment of children and adults with NF1-PN
4 March 2024 - SpringWorks Therapeutics announced today that the Company has initiated a rolling submission of a new drug application ...
Posted by Michael Wonder on 04 Mar 2024
Federal judge rules against AstraZeneca in lawsuit challenging Medicare drug price negotiation
1 March 2024 - A federal judge in Delaware on Friday ruled against AstraZeneca in a case challenging the constitutionality ...
Posted by Michael Wonder on 04 Mar 2024
Hugel receives US FDA approval for its botulinum toxin Letybo
3 March 2024 - Hugel becomes the first and only Korean company that have market approvals in all three major aesthetic ...
Posted by Michael Wonder on 01 Mar 2024
FDA approves amivantamab-vmjw for EGFR exon 20 insertion mutated non-small cell lung cancer indications
1 March 2024 - Today, the FDA approved amivantamab-vmjw (Rybrevant, Janssen) with carboplatin and pemetrexed for the first-line treatment of ...
Posted by Michael Wonder on 01 Mar 2024
Intercept announces FDA acceptance of supplemental new drug application for Ocaliva (obeticholic acid) for the treatment of PBC
29 February 2024 - FDA has assigned a PDUFA target action date of 15 October 2024. ...
Posted by Michael Wonder on 01 Mar 2024
Biden-Harris Administration issues final guidance to help people with Medicare prescription drug coverage manage prescription drug costs
29 February 2024 - Continuing the ongoing implementation of President Biden’s prescription drug pricing law, the Inflation Reduction Act of 2022, ...
Posted by Michael Wonder on 29 Feb 2024
Indapta Therapeutics receives US FDA fast track designation for lead clinical drug candidate IDP-023 for non-Hodgkin’s lymphoma and myeloma
29 February 2024 - Highly differentiated allogeneic natural killer cell therapy in Phase 1 trial, with initial data expected in second ...
Posted by Michael Wonder on 29 Feb 2024
House looks to weaken Medicare negotiation
29 February 2024 - Two proposals to weaken Medicare’s drug price negotiation program are getting a hearing before a House Energy ...
Posted by Michael Wonder on 28 Feb 2024
Bernie Sanders wants to rein in drug prices. Is he asking the right questions?
28 February 2024 - We have a serious problem of affordability of health care in the US, including the cost of ...