Approvals

Janssen gets FDA breakthrough therapy status for JNJ-6372 to treat metastatic NSCLC

The Janssen Pharmaceutical Companies of Johnson & Johnson has secured breakthrough therapy designation from the US Food and Drug Administration (FDA) for its JNJ-61186372 (JNJ-6372) to treat metastatic non-small cell lung cancer (NSCLC).

Novartis gets FDA nod for Isturisa to treat Cushing’s disease

Novartis has secured approval from the US Food and Drug Administration (FDA) for its Isturisa (osilodrostat) oral tablets to treat adults with Cushing’s disease.

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.