Approvals

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.

FDA approves GSK’s Voltaren Arthritis Pain for over-the-counter use in the US

GlaxoSmithKline (LSE/NYSE: GSK) today announced that the U.S. Food and Drug Administration (FDA) has approved Voltaren Arthritis Pain (diclofenac sodium topical gel, 1% (NSAID)- arthritis pain reliever) as an over-the-counter (OTC) product for the temporary relief of arthritis pain in the hand, wrist, elbow, foot, ankle or knee in adults (18 years and older).

Novartis gets EC nod for Beovu to treat wet AMD

Novartis has secured approval from the European Commission (EC) for its Beovu (brolucizumab) to treat wet age-related macular degeneration (AMD).

Roche gets Chinese approval for Tecentriq plus chemotherapy to treat ES-SCLC

Roche has secured approval from the China National Medical Products Administration (NMPA) for Tecentriq (atezolizumab) in combination with chemotherapy (carboplatin and etoposide) as a first-line treatment for patients with extensive-stage small cell lung cancer (ES-SCLC).

ReAlta Life Sciences announces FDA orphan drug designation for PIC1 to treat hypoxic-ischemic encephalopathy

ReAlta Life Sciences announced that US Food and Drug Administration (FDA) has granted orphan drug designation to PIC1-dPEG24 for the treatment of hypoxic-ischemic encephalopathy (HIE) in neonates.

Aimmune’s Palforzia gets FDA approval for treatment of peanut allergy

Aimmune Therapeutics has secured approval for Palforzia [Peanut (Arachis hypogaea) Allergen Powder-dnfp] from the US Food and Drug Administration (FDA) to treat patients with peanut allergy.

FDA approves Merck’s DIFICID to treat Clostridioides difficile in children aged six months and older

Merck, known as MSD outside the United States and Canada, today announced the U.S. Food and Drug Administration (FDA) has approved a New Drug Application (NDA) for DIFICID® (fidaxomicin) for oral suspension, and a supplemental New Drug Application (sNDA) for DIFICID tablets for the treatment of Clostridioides (formerly Clostridium) difficile-associated diarrhea (CDAD) in children aged six months and older.