Here’s a simplified summary of the regulatory updates for various pharmaceutical products:
1. Pfizer’s Elrexfio: Recommended in England for multiple myeloma patients who have tried other treatments. Now available through the Cancer Drugs Fund.
2. AstraZeneca’s Wainzua: Approved in England for treating hereditary transthyretin-related amyloidosis, a rare disease affecting the nervous system.
3. Shorla Oncology’s Jylamvo: Expanded use in the U.S. for treating certain types of leukemia and arthritis in children, making it the only oral methotrexate approved for both adults and children.
4. Eli Lilly’s Mounjaro: Approved in Hong Kong for weight management and diabetes treatment. Launch expected by the end of the year.
5. Merck’s Keytruda: Gained two new approvals in Europe for treating certain gynecologic cancers, bringing its total approved uses in the region to 30.
6. AstraZeneca’s Voydeya: Endorsed in England for treating a rare blood disorder.
7. FDA Review for Camrelizumab and Rivoceranib: Resubmission for a liver cancer treatment combination after a previous rejection.
8. Amneal’s Pyridostigmine Bromide: Approved in the U.S. as a pretreatment for nerve agent poisoning.
9. Amgen’s Lumakras and Vectibix: Review delayed by FDA for a combination treatment for colorectal cancer.
10. Eisai and Biogen’s Leqembi: Facing delays in Australia for an Alzheimer’s treatment.
11. Roche’s Alecensa: Approved in England for post-surgery lung cancer treatment.
12. GSK’s Flublok Vaccine: FDA updated safety data for use in pregnant people.
13. GSK’s Gepotidacin: FDA review underway for a new antibiotic for urinary tract infections.
14. Valneva’s Shigella4V Vaccine: Fast-tracked by the FDA for shigellosis prevention.
15. Johnson & Johnson’s Tecvayli: Expanded approval in England for multiple myeloma treatment.
16. UCB’s Bimzelx: New administration options approved by FDA for psoriasis treatment.
17. AstraZeneca and Daiichi Sankyo’s Enhertu: Approved in China for certain lung cancer patients.
18. Alnylam’s Amvuttra: Under FDA review for heart condition treatment.
19. Takeda’s Fruzaqla: Rejected by NICE for colorectal cancer due to cost concerns.
20. Biogen’s Qalsody: Approved in China for a type of ALS.
21. Johnson & Johnson’s Yuvanci: Approved in Europe for pulmonary hypertension.
22. Eli Lilly’s Retevmo: Received full FDA approval for treating a type of thyroid cancer.
23. Pharming’s Joenja: Approved in England for a rare immune disorder.
24. Bayer’s Nubeqa: Filed for FDA approval to treat a type of prostate cancer without chemotherapy.
25. China’s Approval of Regeneron and Sanofi’s Dupixent: Expanded use for COPD treatment.
26. Amgen’s Tepezza: Approved in Japan for thyroid eye disease.
27. Eli Lilly’s Kisunla: Approved in Japan for early Alzheimer’s treatment.
28. Takeda’s Fruzaqla: Approved in Japan for colorectal cancer.
29. Nxera Pharma’s Quviviq: Approved in Japan for insomnia.
30. Ipsen’s Kayfanda: Approved in Europe for a rare liver disorder.
31. Leo Pharma’s Delgocitinib Cream: FDA review accepted for hand eczema treatment.
32. Astellas’ Vyloy: Approved in Europe for gastric cancer treatment.
33. Daiichi Sankyo’s Vanflyta: Approved in England for a type of leukemia.
34. Bristol Myers Squibb’s Opdivo and Yervoy: FDA review for liver cancer treatment.
35. AbbVie’s Skyrizi: Approved in the UK for ulcerative colitis.
36. AbbVie and Genmab’s Tepkinly: Approved in Europe for a type of lymphoma.
37. AstraZeneca’s Fasenra: Approved in China for asthma.
38. AstraZeneca and Daiichi Sankyo’s Enhertu: FDA Breakthrough designation for breast cancer.
39. Bristol Myers Squibb’s Breyanzi: EMA validation for follicular lymphoma treatment.
40. Theramex’s Yselty: Approved in the