FDA gives Orphan Drug Designation to Faron Pharmaceuticals’ Bexmarilimab
August 29, 2023Research and Development FDA, Faron, ODD, Oncology, leukemia
Faron Pharmaceuticals announced today that the US Food and Drug Administration (FDA) has granted Orphan Drug Designation (ODD) to its …
Takeda and ImmunoGen collaborate for development and commercialisation of Elahere in Japan
August 29, 2023Sales and Marketing Elahere, Immunogen, Oncology, Takeda
ImmunoGen has announced that it has entered into an exclusive collaboration with Takeda Pharmaceutical Company for the development and commercialisation …
Janssen submits sNDA to FDA for full approval of Balversa
August 29, 2023Research and Development Balversa, FDA, Janssen, Oncology
The Janssen Pharmaceutical Companies of Johnson & Johnson has announced the submission of a supplemental New Drug Application (sNDA) to …
FDA approves Sandoz’s Tyruko biosimilar to treat relapsing forms of MS
August 25, 2023Medical Communications FDA, MS, Neurology, Sandoz
Novartis’ Sandoz has announced that the US Food and Drug Administration (FDA) has approved its biosimilar Tyruko (natalizumab-sztn), developed by …
Tarsus Pharmaceuticals’ Xdemvy approved by FDA for treatment of Demodex blepharitis
August 25, 2023Medical Communications Demodex blepharitis, FDA, Opthalmology, Tarsus Pharmaceuticals, eyedrops
Tarsus Pharmaceuticals has announced that the US Food and Drug Administration (FDA) approved its drug Xdemvy (lotillaner ophthalmic solution) 0.25% …
Lynparza granted approval to treat prostate cancer in Japan
August 25, 2023Research and Development Merck, Oncology, astra zeneca, prostate cancer
AstraZeneca and Merck (known as MSD outside the US and Canada) have received approval from the Japanese Ministry of Health, …
Japan approves AstraZeneca’s Soliris for paediatric patients with gMG
August 24, 2023Medical Communications AstraZeneca, MHLW, Musculo-skeletal disorder, gMG, paediatric, soliris
AstraZeneca has announced that Japan’s Ministry of Health, Labour and Welfare (MHLW) has approved Soliris (eculizumab) for the extended use …
FDA grants ODD to NXC-201 as multiple myeloma treatment
August 24, 2023Medical Communications FDA, Nexcella, ODD, Oncology, multiple myeloma
Nexcella has announced that the US Food and Drug Administration (FDA) has granted Orphan Drug Designation (ODD) to NXC-201 for …
GSK confirms positive results from shingles trial in China
August 23, 2023Research and Development GSK, Infections and infestations, clinical trials, shingles
GSK has announced positive results today from its first efficacy trial for Shingrix recombinant zoster vaccine (RZV) in China. These …
Daiichi Sankyo’s Enhertu approved in Japan as treatment for metastatic NSCLC
August 23, 2023Medical Communications Daiichi Sankyo, Enhertu, Japan's MHLW, NSCLC, Oncology, trastuzumab deruxtecan
Daiichi Sankyo has announced that Enhertu (trastuzumab deruxtecan) has been approved in Japan for the treatment of adult patients with …
Eli Lilly shares topline results from LIBRETTO-531 trial for Retevmo
August 23, 2023Research and Development Eli Lilly, Oncology, Retevmo, clinical trial, slpercatinib, thyroid cancer
Eli Lilly has announced topline results from the LIBRETTO-531 study assessing Retevmo (selpercatinib) as an initial treatment for patients with …
LEO Pharma to acquire Timber Pharmaceuticals for up to $36m
August 22, 2023Business Services Dermatology, LEO Pharma, Timber Pharmaceuticals, acquisition
Timber Pharmaceuticals has announced that it has entered a definitive agreement to be acquired by LEO Pharma, with a total …
Merck announces phase 3 LITESPARK-005 trial met primary endpoint
August 22, 2023Research and Development Merck, Oncology, Welireg, belzutifan, clinical trial, renal cell carcinoma
Merck (known as MSD outside of the US and Canada) has shared topline results from its phase 3 LITESPARK-005 trial, …
FDA approves Pfizer’s vaccine for the prevention of RSV in children
August 22, 2023Research and Development FDA, Paediatrics, Pfizer, RSV
On Monday, Pfizer announced that the US Food and Drug Administration (FDA) has approved Abrysvo for the prevention of respiratory …
Recce Pharmaceuticals shares data from phase 1/2 trial for burn wound infection
August 21, 2023Research and Development Recce Pharmaceuticals, Wound Healing, burn wounds, clinical trial, infection
Recce Pharmaceuticals has announced that it has completed its data analysis for its phase 1/2 clinical trial of Recce 327 …
Hutchmed announces phase 3 trial met primary endpoint for primary immune thrombocytopenia treatment
August 21, 2023Research and Development HUTCHMED, Haematology, clinical trial, sovleplenib, thrombocytopenia
Hutchmed has announced that its phase 3 trial ESLIM-01 trial assessing the use of sovleplenib has met its primary endpoint …
FDA approves first ever treatment for rare CHAPLE disease
August 21, 2023Research and Development CHAPLE disease, FDA, Rare Diseases, rare disease
The US Food and Drug Administration (FDA) has approved Regeneron’s Veopoz (pozelimab), a new treatment for CHAPLE disease for both …
Destiny Pharma appoints new CEO Chris Tovey
August 21, 2023Business Services CEO, Chris Tovey, Destiny Pharma, Infections and infestations
Destiny Pharma has announced the appointment of Chris Tovey, who will be replacing Dr Debra Barker as chief executive officer; …
FDA approves IMIDEX’s AI-powered device VisiRad XR
August 18, 2023Research and Development FDA, Radiology, pharma, radiology
The technological pharmaceutical company IMIDEX has been granted clearance from the US Food and Drug Administration (FDA) for its artificial …
AstraZeneca’s Forxiga approved in China for chronic heart failure treatment
August 18, 2023Medical Communications AstraZeneca, Cardiology, China, cardiovascular, heart failure
AstraZeneca has announced that Forxiga (dapagliflozin) has been approved in China to reduce the risk of cardiovascular death, hospitalisation for …
Latest content
Scots neonatal innovations target hearing loss and earlier care
Agentis Health Group acquires Clinical Pharmacist Solutions
