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RSS FeedPosted by Michael Wonder on 13 Jun 2022
FDA approves first systemic treatment for alopecia areata
13 June 2022 - Today, the U.S. FDA approved Olumiant (baricitinib) oral tablets to treat adult patients with severe alopecia areata, ...
Posted by Michael Wonder on 12 Jun 2022
NRx Pharmaceuticals provides update on breakthrough therapy designation request for Zyesami (aviptadil)
10 June 2022 - NRx Pharmaceuticals today announced that the U.S. FDA denied the breakthrough therapy designation request for Zyesami (aviptadil) ...
Posted by Michael Wonder on 11 Jun 2022
FDA approves new oncology drugs quicker than EMA
10 June 2022 - The US FDA is quicker to approve new oncology drugs compared with the EMA, according to ...
Posted by Michael Wonder on 09 Jun 2022
U.S. Senators ask regulators to clear drug patent 'thickets'
9 June 2022 - Letter asks U.S. Patent and Trademark Office to crack down on "highly similar" patents for single ...
Posted by Michael Wonder on 09 Jun 2022
Lupin receives tentative approval from U.S. FDA for ivacaftor tablets
8 June 2022 - Lupin today announced that it has received tentative approval from the United States FDA for its ...
Posted by Michael Wonder on 09 Jun 2022
U.S. FDA approves Foundation Medicine’s FoundationOne CDx as a companion diagnostic for Roche’s Rozlytrek (entrectinib)
9 June 2022 - This approval marks the first and only companion diagnostic indication for Rozlytrek, and another important milestone in ...
Posted by Michael Wonder on 09 Jun 2022
AlgoTx’s ATX01 granted fast track designation by FDA for chemotherapy-induced neuropathic pain
9 June 2022 - AlgoTx announced today that it has received fast track designation from the U.S. FDA for the ...
Posted by Michael Wonder on 09 Jun 2022
Scynexis announces submission of supplemental new drug application of Brexafemme (ibrexafungerp tablets) to the U.S. FDA for an expanded indication for the prevention of recurrent vaginal yeast infection
8 June 2022 - Regulatory submission for the label extension is supported by positive data from the pivotal Phase 3 ...
Posted by Michael Wonder on 08 Jun 2022
Allogene Therapeutics announces the FDA granted regenerative medicine advanced therapy designation to ALLO-501A for large B-cell Lymphoma
8 June 2022 - In the ALPHA trials with ALLO-501 and ALLO-501A, treatment was initiated approximately 2 days from enrollment, eliminating ...
Posted by Michael Wonder on 08 Jun 2022
Vertex announces inaxaplin (VX-147) granted breakthrough therapy designation by U.S. FDA and PRIME designation by the EMA
8 June 2022 - Vertex granted nine breakthrough therapy designations and three PRIME designations across its pipeline programs to date. ...
Posted by Michael Wonder on 08 Jun 2022
FDA grants fast track designation for BioCryst’s ALK-2 inhibitor, BCX9250
8 June 2022 - BioCryst Pharmaceuticals today announced the U.S. FDA has granted fast track designation for BCX9250 for the ...
Posted by Michael Wonder on 07 Jun 2022
FDA approves Dupixent (dupilumab) as first biologic medicine for children aged 6 months to 5 years with moderate to severe atopic dermatitis
7 June 2022 - Dupixent is the first and only biologic medicine approved to treat moderate-to-severe atopic dermatitis from infancy ...
Posted by Michael Wonder on 07 Jun 2022
FDA approves drug for prevention of organ rejection in paediatric recipients of heart and liver transplants
7 June 2022 - The FDA has expanded the use of CellCept (mycophenolate mofetil) to prophylaxis of organ rejection in ...
Posted by Michael Wonder on 06 Jun 2022
Novavax faces high stakes FDA review this week that will decide the fate of its COVID vaccine in the U.S.
6 June 2022 - If they endorse the vaccine, the FDA will almost certainly authorise the shot for adults in the ...
Posted by Michael Wonder on 06 Jun 2022
Bristol Myers Squibb withdraws supplemental biologics license application for Reblozyl (luspatercept-aamt) for non-transfusion dependent beta thalassaemia
3 June 2022 - Bristol Myers Squibb today announced that the company has withdrawn a supplemental biologics license application for ...