FDA
FDA accepts Eisai’s Leqembi sBLA for early AD treatment
June 11, 2024Medical Communications Alzheimer's, Biogen, FDA, Neurology, sBLA
Eisai and Biogen have announced that the US Food and Drug Administration (FDA) has accepted Eisai’s supplemental biologics license application …
GSK’s Arexvy vaccine approved by FDA for RSV prevention in adult patients
June 10, 2024Medical Communications FDA, GSK, Immunology, Vaccine
GSK has announced that the US Food and Drug Administration (FDA) has approved Arexvy (Respiratory Syncytial Virus (RSV) Vaccine, Adjuvanted) …
FDA approves Geron’s Rytelo for treatment of MDS with transfusion-dependent anaemia
June 7, 2024Medical Communications FDA, Geron, Haematology, anaemia, mds
Geron Corporation has announced that the US Food and Drug Administration (FDA) has approved Rytelo (imetelstat) for the treatment of …
Quince Therapeutics gains FDA Fast Track Designation for EryDex System
June 4, 2024Medical Communications EryDex, FDA, Quince Therapeutics, Rare Diseases, fast track designation
Quince Therapeutics has announced that the US Food and Drug Administration (FDA) has granted Fast Track Designation for its EryDex …
Sanofi’s Sarclisa accepted for FDA priority review
May 29, 2024Medical Communications FDA, Oncology, Sanofim, Sarclisa, multiple myeloma, priority review
Sanofi has announced that the US Food and Drug Administration (FDA) has accepted the supplemental Biologics License Application (sBLA) for …
FDA approves Amgen’s Imdelltra for extensive-stage small cell lung cancer
May 17, 2024Medical 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 …
FDA approves Roche’s HPV self-collection screening option
May 15, 2024Medical 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 …
Moderna shares update on RSV vaccine
May 13, 2024Medical 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 …
Pfizer’s Beqvez approved by FDA for haemophilia B treatment
April 29, 2024Medical 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 …
GSK’s Jemperli accepted for FDA review for endometrial cancer treatment
April 24, 2024Medical 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 …
FDA approves ImmunityBio’s Anktiva bladder cancer treatment
April 23, 2024Medical 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 …
Roche’s Alecensa approved by FDA as lung cancer treatment
April 19, 2024Medical 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 …
GSK’s meningococcal vaccine candidate accepted for FDA review
April 16, 2024Medical 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) …
FDA grants ODD to Candel Therapeutics’ pancreatic cancer treatment
April 15, 2024Medical 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, …
FDA clears Oryzon’s phase 1/2 trial for lung cancer treatment
April 10, 2024Research 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 …
