Regulation

Bird Rock Bio files IND application for phase 2 study of Nimacimab for treatment of renal diseases

Bird Rock Bio has filed an investigational new drug (IND) application with the U.S. Food and Drug Administration (FDA) for the initiation of a phase 2 clinical study of nimacimab, also known as RYI-018, in patients with one of the following renal diseases: diabetic kidney disease, focal segmental glomerulosclerosis (FSGS), or immunoglobulin A (IgA) nephropathy.

Bristol Myers Squibb receives EC approval for Zeposia in adults with RRMS with active disease

Bristol Myers Squibb announced that the European Commission (EC) has approved Zeposia (ozanimod) for the treatment of adult patients with relapsing remitting multiple sclerosis (RRMS) with active disease as defined by clinical or imaging features.

FDA grants priority review of Nucala for patients with Hypereosinophilic Syndrome

GlaxoSmithKline (GSK) announced that the US Food and Drug Administration (FDA) has granted a priority review for the company’s application seeking approval of Nucala (mepolizumab) in the treatment of patients with Hypereosinophilic Syndrome (HES) in the US.

FDA approves Opdivo + Yervoy combined with limited chemotherapy as first-line treatment of metastatic or recurrent NSCLC

Bristol Myers Squibb announced that Opdivo (nivolumab) 360 mg plus Yervoy (ipilimumab) 1 mg/kg (injections for intravenous use) given with two cycles of platinum-doublet chemotherapy was approved by the U.S. Food and Drug Administration (FDA) for the first-line treatment of adult patients with metastatic or recurrent non-small cell lung cancer (NSCLC) with no EGFR or ALK genomic tumor aberrations.

FDA approves Dupixent as first biologic medicine for children aged six to 11 years with moderate-to-severe atopic dermatitis

The US Food and Drug Administration (FDA) approved Dupixent (dupilumab) for children aged 6 to 11 years with moderate-to-severe atopic dermatitis whose disease is not adequately controlled with topical prescription therapies or when those therapies are not advisable. Dupixent is the only biologic medicine approved for this patient population.

US FDA approves Takeda’s ALUNBRIG for rare and serious form of lung cancer

Takeda Pharmaceutical Company announced that the U.S. Food and Drug Administration (FDA) approved ALUNBRIG (brigatinib) for adult patients with anaplastic lymphoma kinase-positive (ALK+) metastatic non-small cell lung cancer (NSCLC) as detected by an FDA-approved test.

Novaremed seeks FDA nod for evaluating NRD135S.E1 for treatment of PDPN

Novaremed is seeking the approval of the US Food and Drug Administration (FDA) to begin a phase 2 trial for evaluating its new drug candidate NRD135S.E1 for the treatment of painful diabetic peripheral neuropathy (PDPN).

Enhertu granted orphan drug designation in US for gastric cancer

AstraZeneca and Daiichi Sankyo Company, Limited (Daiichi Sankyo)’s Enhertu (trastuzumab deruxtecan) has been granted Orphan Drug Designation (ODD) in the US for the treatment of patients with gastric cancer, including gastroesophageal junction cancer.

Sunovion gets FDA nod for Kynmobi to treat Parkinson’s disease off episodes

Sunovion Pharmaceuticals has secured approval from the US Food and Drug Administration (FDA) for its Kynmobi (apomorphine hydrochloride) sublingual film (APL-130277) to treat Parkinson’s disease (PD) off episodes.