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RSS FeedPosted by Michael Wonder on 28 Feb 2026
FDA approves Novo Nordisk's Sogroya as the first and only once weekly, long-acting growth hormone for three additional paediatric indications
27 February 2026 - Novo Nordisk today announced that the US FDA has approved three new indications for once weekly Sogroya ...
Posted by Michael Wonder on 28 Feb 2026
FDA approves once weekly Yuwivel (navepegritide) for children with achondroplasia aged 2 years and older
27 February 2026 - Rare paediatric disease priority review voucher granted in connection with approval. ...
Posted by Michael Wonder on 26 Feb 2026
FDA grants accelerated approval to zongertinib for unresectable or metastatic non-squamous non-small cell lung cancer
26 February 2026 - Today, the FDA granted accelerated approval to zongertinib (Hernexeos, Boehringer Ingelheim Pharmaceuticals), a kinase inhibitor, for ...
Posted by Michael Wonder on 26 Feb 2026
FDA approves drug for adult and paediatric patients aged 6 and older with allergic fungal rhinosinusitis
25 February 2026 - The US FDA has approved Dupixent (dupilumab) for the treatment of adult and paediatric patients aged 6 ...
Posted by Michael Wonder on 24 Feb 2026
US FDA has granted accelerated approval of Loargys (pegzilarginase-nbln) for the treatment of hyperargininemia in patients 2 years and older with arginase 1 deficiency
23 February 2026 - Immedica Pharma today announced that the US FDA has granted accelerated approval of Loargys (pegzilarginase-nbln), an ...
Posted by Michael Wonder on 24 Feb 2026
FDA grants traditional approval to encorafenib for metastatic colorectal cancer with a BRAF V600E mutation
24 February 2026 - Today, the FDA granted traditional approval to encorafenib (Braftovi, Array BioPharma, a subsidiary of Pfizer) in ...
Posted by Michael Wonder on 24 Feb 2026
Dupixent (dupilumab) approved in the US as the first and only medicine for allergic fungal rhinosinusitis
24 February 2026 - Regeneron Pharmaceuticals and Sanofi today announced that the US FDA has approved Dupixent (dupilumab) for the treatment ...
Posted by Michael Wonder on 23 Feb 2026
Zepbound (tirzepatide), the most prescribed weight management medication in 2025, now available in multi-dose KwikPen
23 February 2026 - Eli Lilly today announced the US FDA approved a label expansion for Zepbound (tirzepatide) to include the ...
Posted by Michael Wonder on 21 Feb 2026
Vanda Pharmaceuticals announces FDA approval of Bysanti (milsaperidone) for the treatment of bipolar I disorder and schizophrenia - a new chemical entity opening new horizons in psychiatric innovation
20 February 2026 - - Vanda Pharmaceuticals today announced that the US FDA has approved Bysanti (milsaperidone) tablets, a first ...
Posted by Michael Wonder on 21 Feb 2026
FDA approves acalabrutinib with venetoclax for chronic lymphocytic leukaemia or small lymphocytic lymphoma
20 February 2026 - On 19 February 2026, the FDA approved acalabrutinib (Calquence, AstraZeneca) tablets and capsules in combination with venetoclax ...
Posted by Michael Wonder on 20 Feb 2026
Calquence plus venetoclax approved in the US as first all-oral, fixed-duration combination for patients with chronic lymphocytic leukaemia in the 1st-line setting
20 February 2026 - Calquence plus venetoclax demonstrated statistically significant and clinically meaningful improvement in progression-free survival versus chemoimmunotherapy, with 77% ...
Posted by Michael Wonder on 20 Feb 2026
US FDA approves combination treatment of Venclexta (venetoclax) and acalabrutinib for previously untreated patients with chronic lymphocytic leukaemia
20 February 2026 - AbbVie today announced that the US FDA has approved a supplemental new drug application for the combination ...
Posted by Michael Wonder on 18 Feb 2026
Harmony Biosciences receives US FDA approval for Wakix (pitolisant) for the treatment of cataplexy in paediatric narcolepsy
17 February 2026 - Harmony Biosciences today announced that the US FDA has approved its supplemental new drug application for Wakix ...
Posted by Michael Wonder on 18 Feb 2026
Sandoz receives US FDA approval to expand Enzeevu (aflibercept-abzv) label for multiple retinal indications
18 February 2026 - Sandoz today announced that the US FDA has approved an expanded label for Enzeevu (aflibercept-abzv), to include ...
Posted by Michael Wonder on 17 Feb 2026
Acrotech Biopharma announces FDA approval of Adquey (difamilast 1%) ointment for the treatment of mild to moderate atopic dermatitis
13 February 2026 - Acrotech Biopharma, in collaboration with Otsuka, today announces that the US FDA has approved the new ...