Approvals

Kala Pharmaceuticals announces FDA approval of EYSUVIS for short-term treatment of dry eye disease

Kala Pharmaceuticals, a biopharmaceutical company focused on the discovery, development and commercialization of innovative therapies for diseases of the eye, today announced that the US Food and Drug Administration (FDA) has approved EYSUVIS (loteprednol etabonate ophthalmic suspension) 0.25% for the short-term (up to two weeks) treatment of the signs and symptoms of dry eye disease.

US FDA approves Gilead’s antiviral drug Veklury for treatment of Covid-19

The US Food and Drug Administration (FDA) has approved Gilead Sciences’ antiviral drug Veklury (remdesivir) for the treatment of Covid-19 in patients needing hospitalisation.

Novartis gets FDA orphan drug status for branaplam to treat Huntington’s disease

Novartis has secured orphan drug designation from the US Food and Drug Administration (FDA) for its branaplam (LMI070) to treat Huntington’s disease (HD).

Xeris Pharmaceuticals granted fast track designation by FDA for novel concentrated diazepam formulation for injection

Xeris Pharmaceuticals, a specialty pharmaceutical company leveraging its novel technology platforms to develop and commercialize ready-to-use injectable and infusible drug formulations, announced it was granted fast track designation by the Food and Drug Administration (FDA) for the investigation of XP-0863 (diazepam non-aqueous injection) for the treatment of acute repetitive seizures.

Astellas Pharma gets FDA fast track status for ASP036 to treat primary mitochondrial myopathies

Astellas Pharma has secured fast track status from the US Food and Drug Administration (FDA) to develop ASP0367/MA-0211 (ASP0367) as a potential treatment for primary mitochondrial myopathies (PMM).

Versantis receives FDA rare paediatric disease designation for VS-01 to treat urea cycle disorders

Versantis AG, a clinical-stage company developing novel therapies for orphan liver diseases, today announced that the U.S. Food and Drug Administration (FDA) has granted a rare pediatric disease designation (RPDD) to its lead product candidate VS-01, an ammonia clearance enhancer, for the treatment of Urea Cycle Disorders (UCD).

Genentech announces full FDA approval for Venclexta combinations for acute myeloid leukemia

Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), today announced that the U.S. Food and Drug Administration (FDA) has granted full approval of Venclexta (venetoclax) in combination with azacitidine, or decitabine, or low-dose cytarabine (LDAC) for the treatment of newly diagnosed acute myeloid leukemia (AML) in adults 75 years or older, or who have comorbidities that preclude use of intensive induction chemotherapy.

FDA approves expanded indication for Merck’s KEYTRUDA in adult patients with relapsed or refractory cHL

Merck announced that the US Food and Drug Administration (FDA) has approved an expanded label for KEYTRUDA, Merck’s anti-PD-1 therapy, as monotherapy for the treatment of adult patients with relapsed or refractory classical Hodgkin lymphoma (cHL).

Regeneron’s Inmazeb gets FDA approval for Ebola treatment

Regeneron Pharmaceuticals’ antibody cocktail Inmazeb (atoltivimab, maftivimab, and odesivimab-ebgn) has been approved by the US Food and Drug Administration (FDA) for the treatment of Zaire ebolavirus (Ebola virus).