FDA Approvals

Found 16,776 articles

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  AbbVie, Genmab Score FDA Nod for DLBCL as Blood Cancer Space Heats Up

  5/22/2023

  With Friday’s approval, Epkinly edges out Roche’s bi-specific antibody glofitamab, which is also being proposed for diffuse large B-cell lymphoma.
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  Krystal Gets First FDA Approval for Redosable Gene Therapy, Rare Skin Disease

  5/22/2023

  The topical treatment Vyjuvek got the FDA’s greenlight, making it the first redosable gene therapy and the first therapeutic for the rare skin disease dystrophic epidermolysis bullosa.

• US FDA approves the Cyltezo® Pen, a new autoinjector option, ahead of July 1 commercial launch

  5/22/2023

  Boehringer Ingelheim announced today that the U.S. Food and Drug Administration (FDA) has approved the Cyltezo ® Pen, a new autoinjector option for Cyltezo (adalimumab-adbm), an FDA-approved Interchangeable biosimilar to Humira® (adalimumab). Initially approved as a pre-filled syringe, Cyltezo is indicated to treat multiple chronic inflammatory diseases.

• FDA Approves AYVAKIT® (avapritinib) as the First and Only Treatment for Indolent Systemic Mastocytosis

  5/22/2023

  Blueprint Medicines Corporation (Nasdaq: BPMC) today announced that the U.S. Food and Drug Administration (FDA) has approved AYVAKIT® (avapritinib) for the treatment of adults with indolent systemic mastocytosis (ISM).

• Sangamo Therapeutics Receives U.S. FDA Fast Track Designation for Isaralgagene Civaparvovec for the Treatment of Fabry Disease

  5/22/2023

  Sangamo Therapeutics, Inc. (Nasdaq: SGMO), a genomic medicine company, today announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track Designation to isaralgagene civaparvovec, or ST-920, a wholly owned gene therapy product candidate for the treatment of Fabry disease.

• FDA Approves Prescription Nasal Spray to Reverse Opioid Overdose

  5/22/2023

  Today, the U.S. Food and Drug Administration approved Opvee, the first nalmefene hydrochloride nasal spray for the emergency treatment of known or suspected opioid overdose in adults and pediatric patients 12 years of age and older.

• Indivior Announces U.S. Food and Drug Administration Approval of OPVEE® (nalmefene) Nasal Spray, An Opioid Overdose Rescue Medicine for Natural and Synthetic Opioids Like Fentanyl

  5/22/2023

  Indivior PLC (LSE: INDV) today announced that the U.S. Food and Drug Administration (FDA) approved OPVEE® (nalmefene) nasal spray for the emergency treatment of known or suspected opioid overdose induced by natural or synthetic opioids in adults and pediatric patients aged 12 years and older, as manifested by respiratory and/or central nervous system depression.

• Beta Bionics Announces FDA Clearance and Commercialization of the iLet Bionic Pancreas

  5/22/2023

  Beta Bionics, Inc. - a medical technology company focused on diabetes - announces FDA 510(k) clearance and the commercial launch of the iLet Bionic Pancreas.

• Centessa Pharmaceuticals Receives Fast Track Designation from the U.S. FDA for SerpinPC for Hemophilia B

  5/22/2023

  Centessa Pharmaceuticals plc today announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to SerpinPC, an investigational novel inhibitor of activated protein C (APC) being developed for the treatment of hemophilia B, with or without inhibitors. 

• Orlucent Receives FDA Breakthrough Device Designation for Handheld Mole Imaging System

  5/22/2023

  Orlucent, Inc. today announced the U.S. Food and Drug Administration (FDA) has granted Breakthrough Device Designation for the company's Orlucent® Skin Fluorescence Imaging System.

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  FDA Panel Backs Pfizer’s Maternal RSV Vaccine Despite Safety Concerns

  5/19/2023

  An advisory committee of outside experts voted unanimously Thursday that Pfizer’s vaccine was effective in preventing severe disease, but some had questions regarding its safety.
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  AbbVie Adds Crohn’s Disease to Rinvoq’s Growing List of Indications

  5/19/2023

  Crohn’s disease is Rinvoq’s seventh approved indication and could potentially help AbbVie weather declining sales for its blockbuster biologic Humira.
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  FDA Approves Bausch + Lomb, Novaliq Dry Eye Disease Drug

  5/19/2023

  The regulator’s approval makes Miebo the first DED treatment that directly addresses tear evaporation. The drug is expected to hit U.S. markets in the second half of 2023.

• EPKINLY™ (epcoritamab-bysp) Approved by U.S. FDA as the First and Only Bispecific Antibody to Treat Adult Patients with Relapsed or Refractory Diffuse Large B-Cell Lymphoma (DLBCL)

  5/19/2023

  AbbVie announced that the U.S. Food and Drug Administration has approved EPKINLYTM, as the first and only T-cell engaging bispecific antibody for the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma, not otherwise specified, including DLBCL arising from indolent lymphoma, and high-grade B–cell lymphoma, after two or more lines of systemic therapies.

• EPKINLY™ (epcoritamab-bysp) Approved by U.S. Food and Drug Administration as the First and Only Bispecific Antibody to Treat Adults with Relapsed or Refractory (R/R) Diffuse Large B-cell Lymphoma (DLBCL)

  5/19/2023

  Genmab A/S announced that the U.S. Food and Drug Administration has approved EPKINLY™ as the first and only T-cell engaging bispecific antibody for the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma, not otherwise specified, including DLBCL arising from indolent lymphoma, and high-grade B‑cell lymphoma, after two or more lines of systemic therapy.

•  Landmark victory for individuals living with DEB and their families, the FDA announced their approval of Krystal Biotech’s VYJUVEK™ for the treatment of Dystrophic Epidermolysis Bullosa (DEB).

  5/19/2023

  400 million people around the world are affected by a rare disease. 95% of rare diseases lack an FDA approved treatment or cure.

• Krystal Biotech Receives FDA Approval for the First-Ever Redosable Gene Therapy, VYJUVEK™ (beremagene geperpavec-svdt) for the Treatment of Dystrophic Epidermolysis Bullosa

  5/19/2023

  Krystal Biotech, Inc. (the Company) (NASDAQ: KRYS), a biotechnology company focused on developing and commercializing genetic medicines for patients with rare diseases, today announced the US Food and Drug Administration (FDA) has approved VYJUVEK™ (beremagene geperpavec-svdt) for the treatment of patients six months of age or older with dystrophic epidermolysis bullosa (DEB).

• FDA Approves First Topical Gene Therapy for Treatment of Wounds in Patients with Dystrophic Epidermolysis Bullosa

  5/19/2023

  Today, the U.S. Food and Drug Administration approved Vyjuvek, a herpes-simplex virus type 1 (HSV-1) vector-based gene therapy, for the treatment of wounds in patients 6 months of age and older with dystrophic epidermolysis bullosa (DEB) with mutation(s) in the collagen type VII alpha 1 chain (COL7A1) gene.  

• Hologic Announces FDA Clearance of Panther Fusion SARS-CoV-2/Flu A/B/RSV Assay

  5/19/2023

  Hologic Inc. (Nasdaq: HOLX) announced today that the U.S. Food and Drug Administration (FDA) has granted 510(k) clearance for the company’s Panther Fusion® SARS-CoV-2/Flu A/B/RSV assay.

• Thermo Fisher Scientific Announces FDA Clearance of Breakthrough Immunoassays to Aid in the Risk Assessment of Preeclampsia

  5/19/2023

  Thermo Fisher Scientific Inc. today announced that the U.S. Food and Drug Administration (FDA) has cleared the Thermo Scientific B·R·A·H·M·S PlGF plus KRYPTOR and B·R·A·H·M·S sFlt-1 KRYPTOR novel biomarkers, the first and only immunoassays to receive breakthrough designation and clearance for the risk assessment and clinical management of preeclampsia, a severe pregnancy complication.