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RSS FeedPosted by Michael Wonder on 28 Dec 2023
Milestone Pharmaceuticals receives refusal to file letter from US FDA for new drug application for etripamil in the treatment of PSVT
26 December 2023 - Milestone Pharmaceuticals announced today that the Company received a refusal to file letter from the US ...
Posted by Michael Wonder on 27 Dec 2023
Imaging Biometrics granted FDA fast track
19 December 2023 - Imaging Biometrics is pleased to announce that the US FDA has granted fast track designation for oral ...
Posted by Michael Wonder on 27 Dec 2023
FDA grants fast track designation to Henlius’ EGFR targeting ADC HLX42 for NSCLC patients with disease progression on EGFR targeted therapies
27 December 2023 - Shanghai Henlius Biotech announced that the US FDA granted fast track designation for HLX42, an investigational EGFR ...
Posted by Michael Wonder on 27 Dec 2023
Coherus announces FDA approval of Udenyca Onbody, a novel and proprietary state of the art delivery system for pegfilgrastim-cbqv
26 December 2023 - Innovative design enables five minute pegfilgrastim delivery time. ...
Posted by Michael Wonder on 27 Dec 2023
US FDA issues complete response letter for dasiglucagon in congenital hyperinsulinism for up to three weeks of dosing due to inspection findings at third-party manufacturing facility
23 December 2023 - The complete response letter is related to deficiencies identified at a third-party manufacturing facility following an inspection ...
Posted by Michael Wonder on 27 Dec 2023
Amgen provides regulatory update on the status of Lumakras (sotorasib)
26 December 2023 - FDA has issued a new post-marketing requirement. ...
Posted by Michael Wonder on 26 Dec 2023
US Food and Drug Administration issues complete response letter for dasiglucagon in congenital hyperinsulinism for up to three weeks of dosing due to inspection findings at third-party manufacturing facility
23 December 2023 - The CRL is related to deficiencies identified at a third-party manufacturing facility following an inspection but are ...
Posted by Michael Wonder on 23 Dec 2023
Patritumab deruxtecan granted priority review in the US for certain patients with previously treated locally advanced or metastatic EGFR mutated non-small-cell lung cancer
22 December 2023 - Submission based on HERTHENA-Lung01 results showing patritumab deruxtecan demonstrated clinically meaningful and durable responses in patients ...
Posted by Michael Wonder on 23 Dec 2023
Sarepta Therapeutics submits efficacy supplement to expand the Elevidys label to include Duchenne muscular dystrophy patients without restriction to age or ambulatory status
22 December 2023 - Sarepta has also submitted the EMBARK post-marketing requirement to the FDA seeking conversion of the Elevidys accelerated ...
Posted by Michael Wonder on 23 Dec 2023
Zealand Pharma submits new drug application to the US FDA for glepaglutide in short bowel syndrome
22 December 2023 - Zealand Pharma today announced the submission of a new drug application to the US FDA for glepaglutide, ...
Posted by Michael Wonder on 22 Dec 2023
BioNTech and DualityBio receive FDA breakthrough therapy designation for antibody drug conjugate candidate BNT323/DB-1303 in endometrial cancer
21 December 2023 - Designation is based on Phase 1/2 safety and efficacy data in patients with HER2 expressing advanced endometrial ...
Posted by Michael Wonder on 22 Dec 2023
Wainua (eplontersen) granted first ever regulatory approval in the US for the treatment of adults with polyneuropathy of hereditary transthyretin-mediated amyloidosis
21 December 2023 - US FDA approval based on NEURO-TTRansform Phase 3 results showing Wainua demonstrated consistent and sustained benefit improving ...
Posted by Michael Wonder on 21 Dec 2023
Johnson & Johnson submits supplemental biologics license application and new drug application to US FDA seeking approval of Rybrevant (amivantamab-vmjw) plus lazertinib for the treatment of patients with EGFR mutated non-small-cell lung cancer
21 December 2023 - Submissions supported by data from landmark Phase 3 MARIPOSA study, which showed statistically significant and clinically meaningful ...
Posted by Michael Wonder on 21 Dec 2023
4DMT receives FDA regenerative medicine advanced therapy designation for 4D-150 genetic medicine for intravitreal treatment of wet AMD, the first RMAT designation in wet AMD
21 December 2023 - Designation follows interim Phase 1 PRISM clinical data for 4D-150 that demonstrated an encouraging safety, tolerability and ...
Posted by Michael Wonder on 21 Dec 2023
Calliditas Therapeutics announces full FDA approval of Tarpeyo, the only FDA approved treatment for IgA nephropathy to significantly reduce the loss of kidney function
20 December 2023 - Calliditas Therapeutics today announced that the US FDA has approved Tarpeyo (budesonide) delayed release capsules to reduce ...