Pharmafile Logo
Pharmafocus logo
Advanced Search

FDA

Showing 15 posts of 1442 posts found.

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 …

News
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 …

News
blood-1813410_960_720

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 …

News
markus-spiske-dnbtfbnqlrc-unsplash_1

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 …

News
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
study_participant_receives_niaid-gsk_candidate_ebola_vaccine

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 …

News
national-cancer-institute-kmvohcb-w5g-unsplash_1

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 …

News

Sirnaomics advances isSCC candidate into late-stage clinical development

June 20, 2023
Research and Development FDA, Oncology, Sirnaomics, clinical trial, isSCC

Global RNA therapeutics biopharmaceutical company Sirnaomics has announced that it has advanced its Squamous Cell Carcinoma in situ (isSCC) candidate …

News

GSK announces extension of FDA’s review for momelotinib

June 20, 2023
Medical Communications FDA, GSK, Oncology, momelotinib, new drug application

GSK has announced that the US Food and Drug Administration (FDA) has extended its review period for the new drug …

News
document-428331_960_720

Nordic Bioscience receives FDA Letter of Support for biomarker in aggressive tumour fibrosis

June 16, 2023
Research and Development FDA, Nordic Bioscience, Oncology, Roche, tumour fibrosis

Danish biomarker company Nordic Bioscience has announced that the US Food and Drug Administration (FDA) has awarded it a Letter …

News
The Gateway to Local Adoption Series

Latest content

Just – Evotec given Gates Foundation grant to increase global biotherapeutics access

January 8, 2026

Johnson & Johnson submits robotic surgical system for De Novo classification

January 8, 2026

EA Pharma announces phase 3 trial for new schizophrenia treatment in Japan

January 7, 2026

Eleva appoints Erich Rajkovic as Chief Business Officer

January 7, 2026

MedPharm announces US FDA inspection of North Carolina manufacturing facility

January 6, 2026