FDA Approvals
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Eyenovia Announces FDA Approval of Mydcombi™, the First Ophthalmic Spray for Mydriasis, Which Also Leverages the Company’s Proprietary Optejet® Device Platform
5/8/2023
Eyenovia, Inc. (NASDAQ: EYEN) today announced that the U.S. Food and Drug Administration (FDA) has approved Mydcombi (tropicamide and phenylephrine hydrochloride ophthalmic spray) 1%/2.5% for inducing mydriasis for diagnostic procedures and in conditions where short term pupil dilation is desired.
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Vedanta Biosciences Receives Fast Track Designation for VE303 and Presents Phase 2 Data at Digestive Disease Week
5/8/2023
Vedanta Biosciences today announced that the U.S. Food and Drug Administration (FDA) granted Fast Track designation to Vedanta’s defined bacterial consortium candidate, VE303, for the prevention of recurrent Clostridioides difficile infection (rCDI).
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During a first-quarter earnings call, Novo revealed its hemophilia candidate had been blocked by the FDA, and that the company is reducing the U.S. supply of lower doses of weight-loss drug Wegovy. -
Dr. Reddy's Laboratories Announces the Launch of Regadenoson Injection 0.4 mg/5 mL in the U.S.
5/5/2023
Dr. Reddy's Laboratories Ltd. today announced the launch of Regadenoson Injection in the U.S. market, a generic therapeutic equivalent of Lexiscan® (Regadenoson) injection, approved by U. S. Food and Drug Administration (USFDA).
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As the COVID-19 market dries up, Moderna looks to FDA approval of its other vaccines including a 2024 commercial launch of its investigational RSV vaccine for older adults.
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Cognixion Receives FDA Breakthrough Device Designation for its Brain-Computer Interface with Augmented Reality for Assistive Communication
5/4/2023
Cognixion®, a leading developer of noninvasive Brain-Computer Interface (BCI) and Augmented Reality (AR) technology, announced today that its flagship device, the Cognixion ONE™ Axon, has been granted U.S. Food and Drug Administration (FDA) Breakthrough Device designation.
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Tonix Pharmaceuticals Announces IND Clearance for TNX-1500 (anti-CD40L mAb) for the Prevention of Organ Rejection in Patients Receiving a Kidney Transplant
5/4/2023
Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP), a clinical-stage biopharmaceutical company, today announced the U.S. Food and Drug Administration (FDA) has cleared the Investigational New Drug (IND) application to support a Phase 1 clinical trial with TNX-1500 (anti-CD40L monoclonal antibody [mAb]).
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Optinose Announces FDA Acceptance of Supplemental New Drug Application for XHANCE
5/4/2023
Optinose today announced the U.S. Food and Drug Administration (FDA) accepted for review its supplemental new drug application (sNDA) requesting approval of XHANCE as a treatment for chronic rhinosinusitis.
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FoundationOne®Liquid CDx Receives FDA-Approval as a Companion Diagnostic for EXKIVITY® (mobocertinib) to Identify Patients with EGFR Exon 20 Insertion Mutations in Advanced Non-Small Cell Lung Cancer
5/4/2023
Foundation Medicine, Inc., a leader in molecular profiling for cancer, today announced that it has received approval from the U.S. Food and Drug Administration (FDA) for FoundationOne®Liquid CDx to be used as a companion diagnostic for EXKIVITY® (mobocertinib).
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FDA Confirms Eligibility of XORLO™ for Accelerated Approval
5/4/2023
XORTX Therapeutics Inc. is pleased to announce completion of a positive and constructive Type D meeting with the U.S. Food and Drug Administration (“FDA”) which resulted in the identification of additional clinical endpoints potentially available for accelerated approval and further understanding of the FDA expectations for the accelerated approval of XORLO™ for the treatment of autosomal dominant polycystic kidney disease (“ADPKD”).
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The regulatory decision marks a turning point in the RSV race in what’s expected to be a competitive space.
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Vertex Announces U.S. FDA Approval for KALYDECO® (ivacaftor) to Treat Eligible Infants With CF Ages 1 Month and Older
5/3/2023
Vertex Announces U.S. FDA Approval for KALYDECO ® (ivacaftor) to Treat Eligible Infants With CF Ages 1 Month and Older.
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US FDA Approves GSK’s AREXVY, the World’s First Respiratory Syncytial Virus (RSV) Vaccine for Older Adults
5/3/2023
GSK plc (LSE/NYSE: GSK) today announced that the US Food and Drug Administration (FDA) has approved AREXVY (respiratory syncytial virus vaccine, adjuvanted) for the prevention of lower respiratory tract disease (LRTD) caused by respiratory syncytial virus (RSV) in individuals 60 years of age and older.
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FDA Approves First Respiratory Syncytial Virus (RSV) Vaccine
5/3/2023
Today, the U.S. Food and Drug Administration approved Arexvy, the first respiratory syncytial virus (RSV) vaccine approved for use in the United States.
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Kamada Announces U.S. FDA Approval of its Application to Manufacture CYTOGAM® at the Company’s Facility in Israel
5/3/2023
Kamada Ltd. (NASDAQ: KMDA; TASE: KMDA.TA), a vertically integrated global biopharmaceutical company, focused on specialty plasma-derived therapeutics, today announced that the U.S. Food and Drug Administration (FDA) has approved its application to manufacture CYTOGAM® (Cytomegalovirus Immune Globulin Intravenous [Human]) (CMV-IGIV) at the Company’s facility in Beit Kama, Israel.
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Olympus Announces FDA Clearance of New Endoscopy System and Compatible Endoscopes
5/2/2023
Olympus announced today the FDA clearance of the new EVIS X1 endoscopy system, along with two compatible gastrointestinal endoscopes: the GIF-1100 gastrointestinal videoscope.
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Tenaya Therapeutics Receives FDA Fast Track Designation for TN-201
5/2/2023
Tenaya Therapeutics, Inc. today announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation for its gene therapy product candidate, TN-201, being developed for the treatment of Myosin Binding Protein C3 (MYBPC3)-associated hypertrophic cardiomyopathy (HCM).
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RENUVION® RECEIVES FDA CLEARANCE FOR SPECIFIC USE AFTER LIPOSUCTION
5/2/2023
Apyx Medical Corporation today announced that it has received 510(k) clearance from the U.S. Food and Drug Administration ("FDA") for the use of its APR Handpiece in procedures for coagulation of soft tissues following liposuction, the most popular plastic surgery procedure in the world.
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Otsuka and Lundbeck won approval Friday for Abilify Asimtufii, a long-acting injectable that provides two months of symptom relief in patients with schizophrenia or bipolar I disorder. -
The Oncologic Drugs Advisory Committee voted 11–1 supporting Merck’s and AstraZeneca’s PARP inhibitor for metastatic castration-resistant prostate cancer patients with BRCA mutations.