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RSS FeedPosted by Michael Wonder on 26 Jul 2026
FDA approves zidesamtinib for ROS1 positive non-small-cell lung cancer
24 July 2026 - On 22 July 2026, the FDA approved zidesamtinib (Jideytro, Nuvalent) for adults with locally advanced or metastatic ...
Posted by Michael Wonder on 26 Jul 2026
Otsuka receives FDA approval for first in class Simtriyo (centanafadine) for the treatment of attention-deficit hyperactivity disorder in adults and paediatric patients aged 6 years and older
24 July 2026 - Simtriyo will be commercially available later this year following scheduling by the US Drug Enforcement Administration. ...
Posted by Michael Wonder on 26 Jul 2026
Revolution Medicines’ new drug application for daraxonrasib accepted for review by US FDA for previously treated metastatic pancreatic cancer
22 July 2026 - Revolution Medicines today announced that the US FDA accepted for review the company’s new drug application for ...
Posted by Michael Wonder on 25 Jul 2026
FDA approves first non-prescription fixed dose combination of acetaminophen and naproxen sodium for 12 hour pain relief
24 July 2026 - Today, the FDA approved Tylenol with Naproxen (acetaminophen 325 mg/naproxen sodium 110 mg tablets), the first ...
Posted by Michael Wonder on 23 Jul 2026
Lundbeck receives FDA fast rack designation for Lu AH69593, an investigational orexin 2 receptor agonist for narcolepsy
23 July 2026 - Lundbeck today announced that the US FDA has granted fast track designation to Lu AH69593, the company's ...
Posted by Michael Wonder on 23 Jul 2026
FDA grants priority review for Pfizer’s Talzenna plus Xtandi for the treatment of metastatic prostate cancer
22 July 2026 - Pfizer today announced that the US FDA accepted for priority review a supplemental new drug application ...
Posted by Michael Wonder on 21 Jul 2026
Axsome Therapeutics announces FDA acceptance of new drug application for AXS-12 for the treatment of cataplexy in narcolepsy
15 July 2026 - Axsome Therapeutics today announced that the US FDA has accepted for filing the Company’s new drug application ...
Posted by Michael Wonder on 21 Jul 2026
Acadia Pharmaceuticals receives FDA fast track designation for remlifanserin in Alzheimer's disease psychosis
20 July 2026 - Acadia Pharmaceuticals today announced that the US FDA has granted fast track designation to remlifanserin, an investigational, ...
Posted by Michael Wonder on 21 Jul 2026
Oncolytics Biotech receives fast track designation for pelareorep in second-line and later anal cancer
20 July 2026 - Oncolytics Biotech today announced that the US FDA has granted fast track designation to pelareorep in combination ...
Posted by Michael Wonder on 21 Jul 2026
Dyne Therapeutics announces US FDA acceptance of biologics license application for z-rostudirsen in exon 51 Duchenne muscular dystrophy
20 July 2026 - Dyne Therapeutics today announced that the US FDA has accepted for review the biologics license application ...
Posted by Michael Wonder on 19 Jul 2026
US FDA accepts Bristol Myers Squibb's new drug application for mezigdomide in patients with relapsed or refractory multiple myeloma
13 July 2026 - Bristol Myers Squibb today announced that the US FDA has accepted a new drug application for ...
Posted by Michael Wonder on 19 Jul 2026
US FDA accepts BioMarin’s supplemental new drug application for full approval of Voxzogo (vosoritide) for children with achondroplasia
13 July 2026 - BioMarin today announced that the US FDA has accepted the company's supplemental new drug application for Voxzogo ...
Posted by Michael Wonder on 19 Jul 2026
FDA grants traditional approval to selpercatinib for locally advanced or metastatic RET fusion-positive solid tumors
14 July 2026 - Today, the FDA granted traditional approval to selpercatinib (Retevmo, Eli Lilly) for adult and pediatric patients ...
Posted by Michael Wonder on 18 Jul 2026
FDA accepts Shionogi’s sNDA for Fetroja (cefiderocol) for use in pediatric patients with serious infections caused by susceptible gram negative bacteria submission intends to address a critical therapeutic gap for vulnerable young patients facing drug-resistant pathogens
17 July 2026 - Shionogi announced the US FDA has accepted a supplemental new drug application for Fetroja (cefiderocol) for ...
Posted by Michael Wonder on 17 Jul 2026
FDA approves gedatolisib with fulvestrant, with or without palbociclib, for HR positive, HER2 negative locally advanced or metastatic breast cancer
14 July 2026 - Today, the FDA approved gedatolisib (Revtorpyk, Celcuity) in combination with fulvestrant, with or without palbociclib, for ...