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Showing 15 posts of 1340 posts found.

FDA approves a second OTC naloxone nasal spray

July 31, 2023
Medical 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 …

News
stethoscope_and_background_doctor

Aevice Health gains FDA clearance for respiratory monitoring platform

July 21, 2023
Research 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 …

News
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FDA approves AstraZeneca’s drug to prevent RSV in babies and young children

July 18, 2023
Research 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 …

News

FDA approves first OTC daily oral contraceptive pill

July 14, 2023
Medical 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 …

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Alzheimer's brain

FDA grants Alzheimer’s disease drug Leqembi full approval

July 7, 2023
Medical 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 …

News

FDA grants Priority Review for Astellas Pharma’s BLA for cancer drug

July 6, 2023
Research 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 …

News

Skyline Therapeutics receives FDA clearance of IND for candidate for neovascular age-related macular degeneration

July 5, 2023
Research 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 …

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FDA approves BioMarin’s Roctavian for adults with severe haemophilia A

June 30, 2023
Medical 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) …

News
diabetes

First cellular therapy for patients with type 1 diabetes approved by FDA

June 29, 2023
Medical 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 …

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GSK receives FDA Fast Track designation for novel gonorrhoea vaccine

June 27, 2023
Research 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 …

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lungs

Verona Pharma submits FDA New Drug Application for COPD treatment

June 27, 2023
Research 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 …

News

FDA approves Pfizer’s Litfulo for patients with severe alopecia areata

June 26, 2023
Medical 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 …

News
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Moderna files for FDA authorisation for updated COVID-19 vaccine

June 23, 2023
Research 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 …

News

FDA approves new medicines to treat paediatric type 2 diabetes

June 22, 2023
Medical 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 …

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FDA approves Pfizer’s HRR mCRPC drug

June 21, 2023
Medical 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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FDA grants ODD to Nexcella’s NXC-201 as treatment for amyloid light chain amyloidosis

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AstraZeneca and Daiichi Sankyo’s datopotamab deruxtecan performs well in phase 3 trial

September 22, 2023

Novo Nordisk partners with UNICEF to prevent global childhood obesity

September 21, 2023

EC approves Menarini Group’s Orserdu for breast cancer treatment

September 21, 2023

Pharmanovia acquires CNS portfolio from Sanofi

September 20, 2023