Pharmafile Logo
Pharmafocus logo
Advanced Search

FDA

Showing 15 posts of 1410 posts found.

FDA approves Amgen’s Imdelltra for extensive-stage small cell lung cancer

May 17, 2024
Medical Communications Amgen, FDA, Oncology, lung cancer

Amgen has announced that the US Food and Drug Administration (FDA) has approved Imdelltra (tarlatamab-dlle) for the treatment of adult …

News

FDA approves Roche’s HPV self-collection screening option

May 15, 2024
Medical Communications FDA, HPV, Oncology, Roche, cervical cancer

Roche has announced that the US Food and Drug Administration (FDA) has approved its human papillomavirus (HPV) self-collection solution. This …

News

Moderna shares update on RSV vaccine

May 13, 2024
Medical Communications FDA, Immunology, Moderna, Vaccine

Moderna has announced that the US Food and Drug Administration (FDA) has shared that it will not complete its review …

News
anirudh-djo3injpaoe-unsplash_3

Pfizer’s Beqvez approved by FDA for haemophilia B treatment

April 29, 2024
Medical Communications FDA, Haematology, Pfizer, haemophilia

Pfizer has announced that the US Food and Drug Administration (FDA) has approved Beqvez (fidanacogene elaparvovec-dzkt) for the treatment of …

News

GSK’s Jemperli accepted for FDA review for endometrial cancer treatment

April 24, 2024
Medical Communications FDA, GSK, Oncology, endometrial cancer, sBLA

GSK has announced that the US Food and Drug Administration (FDA) has accepted its supplemental Biologics License Application (sBLA) for …

News

FDA approves ImmunityBio’s Anktiva bladder cancer treatment

April 23, 2024
Medical Communications Anktiva, FDA, ImmunityBio, Oncology, bladder cancer

ImmunityBio has announced that the US Food and Drug Administration (FDA) has approved Anktiva (N-803, or nogapendekin alfa inbakicept-pmln) plus …

News

Roche’s Alecensa approved by FDA as lung cancer treatment

April 19, 2024
Medical Communications FDA, Oncology, Roche, lung cancer

Roche has announced that the US Food and Drug Administration (FDA) has approved Alecensa (alectinib) for the adjuvant treatment following …

News

GSK’s meningococcal vaccine candidate accepted for FDA review

April 16, 2024
Medical Communications FDA, GSK, Immunology, meningococcal

GSK has announced that the US Food and Drug Administration (FDA) has accepted for review a Biologics License Application (BLA) …

News

FDA grants ODD to Candel Therapeutics’ pancreatic cancer treatment

April 15, 2024
Medical Communications Candel Therapeutics, FDA, ODD, Oncology, Pancreatic cancer

Candel Therapeutics has announced that the US Food and Drug Administration (FDA) has granted Orphan Drug Designation (ODD) to CAN-2409, …

News

FDA clears Oryzon’s phase 1/2 trial for lung cancer treatment

April 10, 2024
Research and Development FDA, Oncology, Oryzon, lung cancer

Oryzon Genomics has announced that the US Food and Drug Administration (FDA) has approved its investigational new drug (IND) application …

News

FDA accepts UCB’s sBLA for Bimzelx

April 5, 2024
Medical Communications Bimzelx, FDA, Pharmacy, UCB, sBLA

UCB has announced that the US Food and Drug Administration (FDA) has accepted for review its supplemental Biologics License Application …

News

FDA approves Basilea’s antibiotic Zevtera for three indications

April 4, 2024
Medical Communications Basilea Pharmaceutica, FDA, Infections and infestations, Zevtera, antibiotic

Basilea Pharmaceutica has announced that the US Food and Drug Administration (FDA) has approved Zevtera (ceftobiprole medocaril sodium for injection), …

News

FDA approves Eko Health’s AI for heart failure detection

April 3, 2024
Medical Communications Cardiology, Eko Health, FDA, heart failure, low ejection fraction

Eko Health has announced that the US Food and Drug Administration (FDA) has approved its Low Ejection Fraction (Low EF) …

News

FDA accepts BLA for AstraZeneca and Daiichi Sankyo’s datopotamab deruxtecan for breast cancer treatment

April 2, 2024
Research and Development AstraZeneca, Daiichi Sankyo, FDA, Oncology, bla, breast cancer

AstraZeneca and Daiichi Sankyo have announced that their Biologics License Application (BLA) for datopotamab deruxtecan (Dato-Dxd) has been accepted in …

News

FDA approves Roche’s test for malaria in blood donors

April 2, 2024
Business Services FDA, Infections and infestations, blood donation, malaria

Roche has announced that the US Food and Drug Administration (FDA) has approved its cobas Malaria test for use on …

News

Latest content

FDA approves Amgen’s Imdelltra for extensive-stage small cell lung cancer

May 17, 2024

AstraZeneca shares results from phase 3 trial of COVID-19 prevention drug

May 17, 2024

GSK pledges £45m to Fleming Initiative to fight AMR

May 16, 2024

NeuroSense partners with PhaseV on upcoming phase 3 ALS trial

May 16, 2024

AstraZeneca adds new heart failure target through collaboration with BenevolentAI

May 15, 2024