Approvals

Zydus secures DCGI approval for Saroglitazar to treat liver disease

India-based pharmaceutical firm Zydus Cadila said that its new drug application (NDA) for Saroglitazar has been approved by the Drug Controller General of India (DCGI) to treat non-cirrhotic non-alcoholic steatohepatitis (NASH) in India.

Alnylam gets EC nod for Givlaari to treat acute hepatic porphyria

Alnylam Pharmaceuticals has secured marketing authorisation from the European Commission (EC) for its Givlaari (givosiran) to treat acute hepatic porphyria (AHP) in adults and adolescents aged 12 years and older.

FDA approves GSK’s Advil Dual Action with Acetaminophen OTC pain reliever

GlaxoSmithKline (GSK) has secured approval for Advil Dual Action with Acetaminophen from the US Food and Drug Administration (FDA) as an over-the-counter (OTC) product for pain relief.

Lysogene receives FDA fast track designation for LYS-SAF302 gene therapy in MPS IIIA

Lysogene, a pioneering Phase 3 gene therapy platform company targeting central nervous system (CNS) diseases, announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track Designation to its LYS-SAF302 program for the treatment of mucopolysaccharidosis Type IIIA (MPS IIIA).

Trulicity gets FDA nod for reducing CV risk in type 2 diabetes patients

Eli Lilly and Company (Lilly) has been granted approval for Trulicity (dulaglutide) from the US Food and Drug Administration (FDA) for reducing the risk of major adverse cardiovascular events (MACE) in adults having type 2 diabetes.

Lundbeck gets FDA nod for migraine prevention drug Vyepti

Lundbeck, a Danish pharmaceutical company, has secured approval from the US Food and Drug Administration (FDA) for its Vyepti as a preventive treatment for migraine in adult patients.

FORMA Therapeutics announces FT-4202 granted fast track designation and rare paediatric disease designation to treat sickle cell disease

FORMA Therapeutics, a clinical-stage biopharmaceutical company focused on rare hematologic diseases and cancers, today announced the U.S. Food and Drug Administration (FDA) has granted Fast Track designation and Rare Pediatric Disease designation for its lead clinical asset, FT-4202, in development as a disease-modifying treatment for sickle cell disease (SCD). FT-4202 is a selective pyruvate kinase-R (PKR) activator that exhibits the potential to beneficially impact both anemia and vaso-occlusive crises for people living with SCD.

Seattle Genetics, Astellas get FDA breakthrough therapy status for Padcev plus Keytruda to treat bladder cancer

Seattle Genetics and Astellas Pharma have secured a breakthrough therapy designation from the US Food and Drug Administration (FDA) for Padcev in combination with Merck’s anti-PD-1 therapy Keytruda to treat advanced bladder cancer.

ALX Oncology’s ALX148 receives two fast track designations from FDA

ALX Oncology, a clinical-stage immuno-oncology company developing therapies to block the CD47 checkpoint mechanism, announced that the U.S. Food and Drug Administration (FDA) has granted two Fast Track designations for its lead candidate, ALX148, for the first-line treatment of patients with head and neck squamous cell carcinoma (HNSCC), and for the second-line treatment of patients with HER2-positive gastric or gastroesophageal junction (gastric/GEJ) carcinoma.