Regulation

Banner Life Sciences announces final FDA approval of BAFIERTAM for multiple sclerosis

Banner Life Sciences, a privately held specialty pharmaceutical company, announced that the U.S. Food and Drug Administration (FDA) granted final approval of BAFIERTAM (monomethyl fumarate) delayed-release capsules for the treatment of relapsing forms of multiple sclerosis (MS).

FDA approves Zejula in platinum-responsive advanced ovarian cancer regardless of biomarker status

GlaxoSmithKline announced the US Food and Drug Administration (FDA) approved the company’s supplemental New Drug Application (sNDA) for Zejula (niraparib), an oral, once-daily poly (ADP-ribose) polymerase (PARP) inhibitor, as a monotherapy maintenance treatment for women with advanced epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in a complete or partial response to first-line platinum-based chemotherapy, regardless of biomarker status.

FDA approves additional dosage of KEYTRUDA across all adult indications

Merck said that the US Food and Drug Administration (FDA) has given its approval for the use of its cancer drug KEYTRUDA (pembrolizumab) at an additional dosage of 400mg every six weeks (Q6W) across all indications in adult patients.

Takeda gets FDA breakthrough therapy status for mobocertinib to treat certain type of lung cancer

Takeda Pharmaceutical has secured breakthrough therapy status from the US Food and Drug Administration (FDA) for its investigational drug mobocertinib (TAK-788) to treat patients with metastatic non-small cell lung cancer (NSCLC).

Janssen announces submission of two applications to US FDA seeking approval of SIMPONI ARIA to treat polyarticular juvenile idiopathic arthritis and juvenile psoriatic arthritis

The Janssen Pharmaceutical Companies of Johnson & Johnson announced the submission of two supplemental Biologics License Applications (sBLA) to the U.S. Food and Drug Administration (FDA) seeking approval of SIMPONI ARIA® (golimumab) for the treatment of polyarticular juvenile idiopathic arthritis (pJIA) and juvenile psoriatic arthritis (jPsA), in patients two years of age and older in combination with methotrexate

Sanofi gets FDA nod for MenQuadfi meningococcal vaccine

French drugmaker Sanofi has secured approval from the US Food and Drug Administration (FDA) for its MenQuadfi meningococcal vaccine.

Akili announces ENDEAVOR Digital Attention Treatment is available for children with ADHD under FDA’s COVID-19 enforcement discretion guidance

Akili today announced that ENDEAVOR (AKL-T01) is now available for use by children with attention deficit hyperactivity disorder (ADHD) and their families.

Novartis gets FDA RMAT designation for Kymriah in follicular lymphoma

Novartis has secured regenerative medicine advanced therapy (RMAT) designation from the US Food and Drug Administration (FDA) for its Kymriah (tisagenlecleucel) for an investigational new indication to treat patients with relapsed or refractory (r/r) follicular lymphoma (FL).

Nexus Pharmaceuticals announces approval of Emerphed injection

Nexus Pharmaceuticals announced that has received U.S. Food and Drug Administration (FDA) approval for its patent-pending New Drug Application (NDA) Emerphed, the first and only premixed ephedrine in a ready-to-use 50 mg/10 mL vial. With no need for compounding, diluting, or mixing, Emerphed saves valuable staff time while also reducing the potential for preparation error and waste.