Regulation

Ocular seeks FDA nod for expanded indication of Dextenza eye treatment

Ocular Therapeutix is seeking approval from the US Food and Drug Administration (FDA) for Dextenza (dexamethasone ophthalmic insert) to expand the current indication to include the treatment of ocular inflammation following ophthalmic surgery.

Novartis gets breakthrough therapy status for sickle cell disease treatment crizanlizumab

Novartis has secured breakthrough therapy designation from the US Food and Drug Administration (FDA) for crizanlizumab (SEG101) to prevent vaso-occlusive crises (VOCs) in patients of all genotypes with sickle cell disease (SCD).

Ironwood, Allergan set to resolve LINZESS patent litigation with Mylan

Ironwood Pharmaceuticals and Allergan have reached an agreement with Mylan Pharmaceuticals to resolve patent litigations over Mylan’s abbreviated new drug applications (ANDAs) seeking approval to market generic versions of LINZESS (linaclotide) before the expiration of their applicable patents.

BMS’ Sprycel secures FDA approval to treat pediatric Ph+ ALL

The US Food and Drug Administration (FDA) has expanded the approval of Bristol-Myers Squibb’s (BMS) Sprycel (dasatinib) tablets to include the treatment of newly diagnosed Philadelphia chromosome-positive (Ph+) acute lymphoblastic leukemia (ALL) in pediatric patients, aged one year or more.

Zydus Cadila secures USFDA nod to market acne drug

Zydus Cadila, an Indian pharmaceutical company, has obtained final approval from the US Food and Drug Administration (FDA) to market Clindamycin Phosphate and Benzoyl Peroxide Gel.

US FDA approves Sanofi’s new pediatric vaccine

The US Food and Drug Administration (FDA) has approved Sanofi’s pediatric hexavalent combination vaccine for use in children between six weeks and five years of age.

FDA accepts Kala Pharmaceuticals’ NDA for KPI-121 0.25%

The US Food and Drug Administration (FDA) has accepted a new drug application (NDA) submitted by Kala Pharmaceuticals for its KPI-121 0.25% product candidate.

FDA approves Ultomiris for use in treatment of rare blood disease

The US Food and Drug Administration (FDA) has approved Ultomiris (ravulizumab) injection for use in the treatment of adult patients with paroxysmal nocturnal hemoglobinuria (PNH).

AstraZeneca’s partner FibroGen gets approval in China for CKD treatment roxadustat

AstraZeneca’s partner FibroGen China has secured marketing approval from the China’s National Medical Products Administration (NMPA) for roxadustat to treat anemia in chronic kidney disease (CKD) patients on dialysis.