FDA
FDA approves a second OTC naloxone nasal spray
July 31, 2023Medical Communications FDA, Nasal Spray, OTC, OTC Products, naloxone, opioids
The US Food and Drug Administration (FDA) has announced that it has approved RiVive, 3mg naloxone hydrochloride nasal spray for …
Aevice Health gains FDA clearance for respiratory monitoring platform
July 21, 2023Research and Development Aevice Health, Devices, FDA, respiratory monitoring
Remote respiratory monitoring solutions company Aevice Health has announced that it has received clearance from the US Food and Drug …
FDA approves AstraZeneca’s drug to prevent RSV in babies and young children
July 18, 2023Research and Development AstraZeneca, FDA, Immunology, RSV, Vaccine, paediatrics
The US Food and Drug Administration (FDA) has announced that it has approved Beyfortus (nirsevimab-alip) for the prevention of respiratory …
FDA approves first OTC daily oral contraceptive pill
July 14, 2023Medical Communications Contraception, FDA, OTC, Opill, contraceptive pill
The US Food and Drug Administration (FDA) has announced that it has approved the Opill (norgestrel) tablet for nonprescription use …
FDA grants Alzheimer’s disease drug Leqembi full approval
July 7, 2023Medical Communications Alzheimer's disease, Biogen, Eisai, FDA, Neurology
Japanese pharmaceutical company Eisai and US-based biotechnology company Biogen have announced that the US Food and Drug Administration (FDA) has …
FDA grants Priority Review for Astellas Pharma’s BLA for cancer drug
July 6, 2023Research and Development Astellas Pharma, Biologics License Application, FDA, GEJ, Oncology
Japanese pharmaceutical company Astellas Pharma has announced that the US Food and Drug Administration (FDA) has granted Priority Review for …
Skyline Therapeutics receives FDA clearance of IND for candidate for neovascular age-related macular degeneration
July 5, 2023Research and Development FDA, IND, Opthalmology, Skyline Therapeutics, neovascular age-related macular degeneration
Skyline Therapeutics has announced that the US Food and Drug Administration (FDA) has cleared its Investigational New Drug (IND) application …
FDA approves BioMarin’s Roctavian for adults with severe haemophilia A
June 30, 2023Medical Communications BioMarin, FDA, Haematology, Roctavian, haemophilia
Global biotechnology company BioMarin Pharmaceuticals has announced that the US Food and Drug Administration (FDA) has approved Roctavian (valoctocogene roxaparvocec-rvox) …
First cellular therapy for patients with type 1 diabetes approved by FDA
June 29, 2023Medical Communications Diabetes, FDA, Lantidra, Type 1 diabetes, diabetes
The US Food and Drug Administration (FDA) has announced that it has approved Lantidra, the first allogeneic (donor) pancreatic islet …
GSK receives FDA Fast Track designation for novel gonorrhoea vaccine
June 27, 2023Research and Development FDA, GSK, Infections and infestations, Vaccine, fast track designation, gonorrhoea
GSK has announced that the US Food and Drug Administration (FDA) has granted Fast Track designation for its investigational vaccine …
Verona Pharma submits FDA New Drug Application for COPD treatment
June 27, 2023Research and Development COPD, Cardiology, FDA, ensifentrine, new drug application, verona pharma
UK-based Verona Pharma has announced that it has submitted a New Drug Application (NDA) to the US Food and Drug …
FDA approves Pfizer’s Litfulo for patients with severe alopecia areata
June 26, 2023Medical Communications FDA, Litfulo, Pfizer, Pharmacy, alopecia, alopecia areata
Pfizer has announced that the US Food and Drug Administration (FDA) has approved its Litfulo (ritlecitinib) for patients over the …
Moderna files for FDA authorisation for updated COVID-19 vaccine
June 23, 2023Research and Development COVID-19, FDA, Immunology, Moderna, Vaccine
Biotechnology company Moderna has announced that it has completed submission of a regulatory application to the US Food and Drug …
FDA approves new medicines to treat paediatric type 2 diabetes
June 22, 2023Medical Communications Diabetes, FDA, Synjardy, jardiance, paediatrics, type 2 diabetes
The US Food and Drug Administration (FDA) has announced that it has approved Jardiance (empagliflozin) and Synjardy (empagliflozin and metformin …
FDA approves Pfizer’s HRR mCRPC drug
June 21, 2023Medical Communications FDA, Oncology, Pfizer, breast cancer, oncology, prostate cancer
US-based pharmaceutical and biotechnology company Pfizer has announced that the US Food and Drug Administration (FDA) has approved its homologous …
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Five Facts about cardiovascular disease
