Blog
RSS FeedPosted by Michael Wonder on 28 Jan 2022
Updates on Olumiant (baricitinib) FDA review for atopic dermatitis
28 January 2022 - Eli Lilly and Incyte today announced updates on the Phase 3 development program for Olumiant (baricitinib) in ...
Posted by Michael Wonder on 28 Jan 2022
Regeneron and Sanofi provide regulatory update on Libtayo (cemiplimab-rwlc) in advanced cervical cancer
28 January 2022 - Regeneron Pharmaceuticals and Sanofi today announced the voluntary withdrawal of the supplemental biologics license application for Libtayo ...
Posted by Michael Wonder on 27 Jan 2022
FDA enforces ClinicalTrials.gov results posting requirements, including threats of financial penalty
27 January 2022 - Clinical trials requiring registration on ClinicalTrials.gov generally must have results submitted no later than one year after ...
Posted by Michael Wonder on 27 Jan 2022
FDA grants breakthrough therapy designation for Dizal Pharmaceutical's DZD9008 in patients with locally advanced or metastatic non-small cell lung cancer harbouring EGFR Exon 20 insertion
27 January 2022 - Breakthrough therapy designation further demonstrates excellent clinical profile of DZD9008 (sunvozertinib). ...
Posted by Michael Wonder on 27 Jan 2022
Lantern Pharma receives rare paediatric disease and orphan drug designations for LP-184 for the treatment of atypical teratoid rhabdoid tumour
24 January 2022 - Lantern Pharma today announced that the U.S. FDA has granted both rare paediatric disease designation and orphan ...
Posted by Michael Wonder on 26 Jan 2022
Pfizer pushes to intervene in lawsuit seeking COVID vaccine information from FDA
27 January 2022 - Pfizer wants to intervene in a Texas federal lawsuit seeking information from the U.S. FDA used ...
Posted by Michael Wonder on 26 Jan 2022
Immunocore announces FDA approval of Kimmtrak (tebentafusp-tebn) for the treatment of unresectable or metastatic uveal melanoma
26 January 2022 - Kimmtrak is the first T cell receptor therapeutic to receive regulatory approval. ...
Posted by Michael Wonder on 26 Jan 2022
Catalyst Biosciences receives rare paediatric disease designation for CB 4332 for the treatment of CFI deficiency
25 January 2022 - Catalyst Biosciences today announced the U.S. FDA has granted rare paediatric disease designation for CB 4332 for ...
Posted by Michael Wonder on 26 Jan 2022
Incyte provides update on parsaclisib and MCLA-145
25 January 2022 - Incyte today announced updates regarding the clinical development of parsaclisib, the Company’s next-generation oral inhibitor of ...
Posted by Michael Wonder on 25 Jan 2022
SNIPR BIOME announces U.S Food and Drug Administration grants fast track designation for SNIPR001 for prevention of bloodstream infections in haematologic cancer patients
25 January 2022 - SNIPR Biome has been granted fast track designation by the U.S. FDA for SNIPR001. ...
Posted by Michael Wonder on 25 Jan 2022
Senhwa’s pidnarulex receives US FDA fast track designation for the treatment of solid tumours with BRCA1/2, PALB2 and other HR gene mutations
24 January 2022 - Senhwa Biosciences announced today that the US FDA has granted fast track designation for Pidnarulex, a first ...
Posted by Michael Wonder on 25 Jan 2022
Genentech’s Evrysdi (risdiplam) granted FDA priority review for treatment of presymptomatic babies under 2 months of age with spinal muscular atrophy
24 January 2022 - Interim data submitted to the FDA show majority of pre-symptomatic babies treated with Evrysdi for at least ...
Posted by Michael Wonder on 25 Jan 2022
Oncopeptides withdraws withdrawal of first marketed drug
24 January 2022 - Swedish pharmaceutical company Oncopeptides announced that it has contacted the U.S FDA and rescinded its 22 ...
Posted by Michael Wonder on 25 Jan 2022
Magnesium Development Company announces FDA breakthrough device designation for resorbable HC screw
24 January 2022 - Magnesium Development Company's fixation solution, the HC Screw, has received the FDA’s breakthrough device designation, having exceeded ...
Posted by Michael Wonder on 25 Jan 2022
Coronavirus (COVID-19) update: FDA limits use of certain monoclonal antibodies to treat COVID-19 due to the Omicron variant
24 January 2022 - In light of the most recent information and data available, today, the FDA revised the authorizations ...