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RSS FeedPosted by Michael Wonder on 24 Jun 2025
Revolution Medicines announces FDA breakthrough therapy designation for daraxonrasib in previously treated metastatic pancreatic cancer with KRAS G12 mutations
23 June 2025 - Breakthrough therapy designation based on promising early clinical evidence observed with daraxonrasib in patients with pancreatic ductal ...
Posted by Michael Wonder on 23 Jun 2025
FDA grants accelerated approval to datopotamab deruxtecan-dlnk for EGFR-mutated non-small cell lung cancer
23 June 2025 - Today, the FDA granted accelerated approval to datopotamab deruxtecan-dlnk (Datroway, Daiichi Sankyo) for adults with locally ...
Posted by Michael Wonder on 22 Jun 2025
Update on FDA review of ruxolitinib cream (Opzelura) for children ages 2-11 with atopic dermatitis
20 June 2025 - Incyte today announced that the US FDA has extended the review period for the supplemental new ...
Posted by Michael Wonder on 20 Jun 2025
Cycle Pharmaceuticals’ Harliku (nitisinone) tablets receive first FDA approval as treatment for alkaptonuria
19 June 2025 - Cycle Pharmaceuticals announced that the FDA has approved Harliku (nitisinone) tablets for the reduction of urine homogentisic ...
Posted by Michael Wonder on 20 Jun 2025
Dupixent (dupilumab) approved in the US as the only targeted medicine to treat patients with bullous pemphigoid
20 June 2025 - Approval based on pivotal results showing improvements in sustained disease remission and reductions in itch and oral ...
Posted by Michael Wonder on 20 Jun 2025
UNAIDS urges Gilead to drop price of new HIV prevention shot
18 June 2025 - The US FDA has approved long-acting injectable lenacapavir for HIV prevention. The new medicine is administered ...
Posted by Michael Wonder on 19 Jun 2025
Bayer files for approval of gadoquatrane in the US
17 June 2025 - Bayer today announced the submission of a new drug application to the US FDA for its ...
Posted by Michael Wonder on 19 Jun 2025
Lilly to offer all approved doses of Zepbound (tirzepatide) single-dose vials through LillyDirect Self Pay Pharmacy Solutions
16 June 2025 - With the addition of 12.5 mg and 15 mg vials, all approved doses of Zepbound will be ...
Posted by Michael Wonder on 18 Jun 2025
Aldeyra Therapeutics resubmits reproxalap new drug application for the treatment of dry eye disease
17 June 2025 - Aldeyra Therapeutics today announced the resubmission of a new drug application to the US FDA for ...
Posted by Michael Wonder on 18 Jun 2025
FDA approves tafasitamab-cxix for relapsed or refractory follicular lymphoma
18 June 2025 - Today, the FDA approved tafasitamab-cxix (Monjuvi, Incyte) with lenalidomide and rituximab for adults with relapsed or ...
Posted by Michael Wonder on 18 Jun 2025
Yeztugo (lenacapavir) is now the first and only FDA approved HIV prevention option offering 6 months of protection
18 June 2025 - Approval based on Phase 3 PURPOSE 1 and PURPOSE 2 data that showed ≥99.9% of participants remained ...
Posted by Michael Wonder on 18 Jun 2025
Bavarian Nordic announces sale of priority review voucher for USD 160 million
18 June 2025 - Bavarian Nordic announced today that it has entered into an agreement to sell its priority review ...
Posted by Michael Wonder on 18 Jun 2025
Duke Street Bio receives FDA fast track designation for DSB2455
10 June 2025 - Duke Street Bio today announced that the US FDA has granted fast track designation to DSB2455, its ...
Posted by Michael Wonder on 18 Jun 2025
Dyne Therapeutics announces FDA breakthrough therapy designation for DYNE-101
17 June 2025 - - Dyne Therapeutics today announced that the US FDA has granted breakthrough therapy designation to DYNE-101 for ...
Posted by Michael Wonder on 18 Jun 2025
BioAegis Therapeutics receives FDA fast track designation for lead product, recombinant human gelsolin, for the treatment of acute respiratory distress syndrome
17 June 2025 - BioAegis Therapeutics announces that the US FDA has granted fast track designation to its lead product candidate, ...