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On 18 September 2024, AstraZeneca announced that its Fasenra® (benralizumab) has been approved by the FDA for eosinophilic granulomatosis with polyangiitis (EGPA).  The approval was based on positive results from a Phase 3 trial (MANDARA) comparing the efficacy and safety o...

On 18 September 2024, Merck (known as MSD outside the US and Canada) announced that Keytruda® (pembrolizumab) has been approved by the FDA, in combination with pemetrexed and platinum chemotherapy, for first-line treatment of adults with unresectable advanced or metastatic ...

On 18 September 2024, Accord BioPharma announced that the FDA has approved a 420mg strength of its Hercessi™ (trastuzumab-strf), biosimilar to Roche’s Herceptin®, for HER2-overexpressing breast and gastric or gastroesophageal junction adenocarcinoma.

Hercessi™ was FD...

On 17 September 2024, GlaxoSmithKline (GSK) announced that Japan’s Ministry of Health has accepted for review a new drug application for Blenrep® (belantamab mafodotin) in combination with BorDex (bortezomib plus dexamethasone) or PomDex (pomalidomide plus dexamethasone) as...

On 17 September 2024, Daiichi Sankyo and MSD announced positive results from a Phase 3 trial of their antibody drug conjugate, patritumab deruxtecan (HER3-DXd).  In the trial (HERTENA-Lung02), patritumab deruxtecan showed statistically significant improvement in progression...

Formycon has announced that it will present study data for Fymskina (FYB202), biosimilar to Janssen’s Stelara® (ustekinumab), at the 2024 European Academy of Dermatology and Venerology Congress (25 to 28 September in Amsterdam) and the 2024 United European Gastroenterology ...

On 13 September 2024, Regeneron and Sanofi announced that their Dupixent® (dupilumab) has received FDA approval as an add-on maintenance treatment for patients aged 12-17 with inadequately controlled chronic rhinosinusitis with nasal polyps (CRSwNP).  This follows the FDA’s...

On 13 September 2024, Eli Lilly announced that its Ebglyss® (lebrikizumab-lbkz) received FDA approval for adults and children 12 years and older with moderate-to-severe atopic dermatitis (eczema) that is not well controlled despite treatment with topical prescription therap...