Welcome to Fierce Pharma’s 2024 regulatory tracker. We’re keeping track of the approval progress for pharmaceutical products, including their expansion into new countries and uses.<\/p>\n
As of October 29, the UK’s National Institute for Health and Care Excellence (NICE) recommends Pfizer’s drug Elrexfio for certain multiple myeloma patients. It’s available on the Cancer Drugs Fund while more data is collected. AstraZeneca’s Wainzua has also received NICE approval for treating hereditary transthyretin amyloidosis, with an estimated 12 patients benefiting in the first year.<\/p>\n
In the US, Shorla’s Jylamvo has expanded FDA approval to treat childhood leukemia and arthritis, marking it as the only oral liquid methotrexate approved for both adult and pediatric use. Eli Lilly’s Mounjaro has been approved in Hong Kong for weight management and diabetes control, with plans to launch by year-end.<\/p>\n
Merck\u2019s Keytruda received two new approvals in Europe, increasing its uses to 30 in the region. AstraZeneca’s Voydeya was endorsed by NICE for a blood disorder, expanding its availability in several countries.<\/p>\n
The FDA is reconsidering a liver cancer treatment combination from Elevar Therapeutics after a previous rejection. A new drug for nerve agent poisoning by Amneal was approved for military use. The FDA extended its review of Amgen’s Lumakras for colorectal cancer due to additional data needs.<\/p>\n
Eisai and Biogen’s Alzheimer’s drug Leqembi faced regulatory challenges in Australia and Europe. NICE approved Roche’s Alecensa for lung cancer treatment, while AstraZeneca and Ionis’ Wainua got UK approval for a rare nerve disease. Sanofi’s Flublok vaccine label now includes safety data for pregnant people.<\/p>\n
GSK’s new antibiotic gepotidacin for UTIs is under FDA review. Valneva’s Shigella vaccine candidate received fast-track status from the FDA. NICE expanded its recommendation for J&J’s Tecvayli for multiple myeloma. UCB’s Bimzelx got new FDA-approved delivery options.<\/p>\n
AstraZeneca’s Enhertu received conditional approval in China for lung cancer. Alnylam has submitted Amvuttra for FDA approval for a heart condition. NICE rejected Takeda’s Fruzaqla for colorectal cancer due to cost concerns, while Ipsen’s Iqirvo for liver disease received UK approval.<\/p>\n
Biogen’s ALS treatment, Qalsody, was approved in China. CSPC’s biosimilar Enyitan, similar to Xolair, got Chinese approval for urticaria. AstraZeneca’s Calquence received a priority review in the US for lymphoma. CSL Behring’s Hemgenix gene therapy got reimbursement approval in Spain.<\/p>\n
Enhertu, from AstraZeneca and Daiichi Sankyo, received FDA priority review for breast cancer. Johnson & Johnson seeks FDA approval for a multiple myeloma treatment combination. An FDA fact sheet update clarified that Pemgarda is effective against a COVID-19 variant.<\/p>\n
Formycon and Fresenius Kabi’s Stelara biosimilar received FDA and EU approval. The European Commission approved J&J’s PAH treatment Yuvanci. Eli Lilly’s Retevmo received full FDA approval for thyroid cancer. Pharming’s Joenja was approved in the UK for a rare immune disorder.<\/p>\n
Bayer seeks FDA approval for Nubeqa in hormone-sensitive prostate cancer. Regeneron and Sanofi’s Dupixent received Chinese approval for COPD. Amgen’s Tepezza was approved in Japan for thyroid eye disease. Eli Lilly’s Kisunla got Japanese approval for Alzheimer’s.<\/p>\n
Takeda’s Fruzaqla received Japanese approval for colorectal cancer, and Nxera’s Quviviq was approved in Japan for insomnia. Ipsen’s Kayfanda was approved by the European Commission for a rare liver disease, and Leo Pharma’s delgocitinib cream got FDA and EU approval for eczema.<\/p>\n
Astellas’ Vyloy was approved in Europe for gastric cancer. Daiichi Sankyo’s Vanflyta received NICE backing for leukemia. After FDA rejections, Xspray plans to refile its leukemia drug Dasynoc. Sanofi and Regeneron’s Dupixent was FDA-approved for adolescents with nasal polyps.<\/p>\n
Merck\u2019s Keytruda, combined with chemotherapy, was FDA-approved for mesothelioma. Avadel’s narcolepsy drug Lumryz review continues. Advanz’s Ocaliva remains on the EU market pending further review. Novavax’s updated COVID-19 vaccine was authorized in the US.<\/p>\n
GSK’s RSV vaccine Arexvy was approved in Europe for high-risk adults. Astellas’ Padcev and Keytruda combo got European approval for cancer. GSK’s Nucala was approved in Japan for nasal polyps. Roche’s PiaSky was approved in Europe for a blood disorder.<\/p>\n
Legend Biotech’s Carvykti was approved in China<\/p>\n","protected":false},"excerpt":{"rendered":"
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