FDA accepts NDA for Karuna’s schizophrenia treatment

November 30, 2023
Medical Communications FDA, Karuna Therapeutics, NDA, Neurology, schizophrenia

Karuna Therapeutics has announced that the US Food and Drug Administration (FDA) has accepted its New Drug Application (NDA) for …

Vivos Therapeutics gains FDA 510(k) clearance for sleep apnea treatment device

November 30, 2023
Medical Communications Devices, FDA, Vivos Therapeutics, sleep apnea

Vivos Therapeutics has announced that it has received 510(k) clearance from the US Food and Drug Administration (FDA) for the …

Tolremo doses first patient in phase 1 trial for drug to combat transcriptional cancer drug resistance

November 29, 2023
Research and Development Oncology, Tolremo, clinical trial, drug resistance, solid tumours

Tolremo Therapeutics has announced that it has dosed the first patient in its first-in-human clinical trial to assess the safety, …

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FDA grants breakthrough device designation to Inflammatix’s TriVerity Acute Infection and Sepsis Test System

November 29, 2023
Research and Development FDA, Infections and infestations, Inflammatix, TriVerity, infection, sepsis

Inflammatix has announced that the US Food and Drug Administration (FDA) has granted Breakthrough Device Designation to the company’s lead …

FDA accepts new drug application for Orexo’s opioid overdose medication

November 28, 2023
Research and Development FDA, Opioid overdose, Pharmacy, opioids, orexo

Orexo has announced that its New Drug Application (NDA) for OX124 has been accepted for review by the US Food …

Arcturus Therapeutics gains FDA ODD for cystic fibrosis treatment

November 28, 2023
Research and Development Arcturus Therapeutics, Chronic Diseases, FDA, ODD, cystic fibrosis

Arcturus Therapeutics has announced that the US Food and Drug Administration (FDA) has granted Orphan Drug Designation (ODD) to ARCT-032, …

Sanofi and Regeneron share results from phase 3 trial for Dupixent as COPD treatment

November 27, 2023
Medical Communications COPD, Cardiology, Dupixent, Sanofi, clinical trial

Sanofi and Regeneron have announced results from the second investigational phase 3 NOTUS trial for Dupixent as a treatment for …

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GSK shares results from phase 3 trial for Blenrep as multiple myeloma treatment

November 27, 2023
Medical Communications Blenrep, GSK, Oncology, clinical trial, multiple myeloma

GSK has announced positive results from a planned interim efficacy analysis of the phase 3 DREAMM-7 head-to-head trial which assessed …

Alladapt Immunotherapeutics gains FDA Fast Track Designation for ADP101 as food allergy treatment

November 24, 2023
Research and Development Alladapt Immunotherapeutics, Allergic Disorders, FDA, fast track designation, food allergy

Alladapt Immunotherapeutics has announced that ADP101 has received Fast Track Designation from the US Food and Drug Administration (FDA) as …

Syncona to acquire Freeline Therapeutics for $28.3m

November 24, 2023
Business Services Freeline Therapeutics, Pharmacy, acquisition, syncona

Freeline Therapeutics has announced that it has entered into a definitive agreement with newly established portfolio company Syncona, in which …

Landos Biophama shares results from phase 1b trial for ulcerative colitis treatment

November 23, 2023
Medical Communications Gastrointestinal tract, Landos Biopharma, clinical trial, ulcerative colitis

Landos Biopharma has announced that it has shared safety, tolerability, pharmacokinetics and clinical efficacy results for the NX-13 phase 1b …

MorphoSys shares phase 3 trial results for pelabresib in myelofibrosis treatment

November 23, 2023
Research and Development Haematology, clinical trial, morphosys, myelofibrosis, pelabresib

MorphoSys has announced topline results from its phase 3 MANIFEST-2 study, which assessed pelabresib, an investigational BET inhibitor, in combination …

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Genentech and NVIDIA enter AI research collaboration

November 22, 2023
Research and Development AI, Genentech, Pharmacy, research collaboration

Genentech has announced that it has entered into a multi-year strategic research collaboration with NVIDIA that is intended to pair …

Merck to acquire Caraway Therapeutics for up to $610m

November 22, 2023
Business Services Caraway Therapeutics, MSD, Merck, Pharmacy, acquisition

Merck (known as MSD outside of the US and Canada) and Caraway Therapeutics have announced that they have entered into …

GSK’s low carbon inhaler, Ventolin, progresses to phase 3 trials 

November 21, 2023
Medical Communications Asthma & COPD, GSK, Ventolin, asthma, carbon-neutral

GSK has announced that in 2024 it intends to start phase 3 trials of a low carbon version of its …

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AstraZeneca launches health-tech business, Evinova

November 21, 2023
Business Services AstraZeneca, Pharmacy, health-tech

AstraZeneca has announced that it has launched Evinova, its new health-tech business, which it is hoped will become a leading …

Almirall gains EC approval of Ebglyss for moderate-to-severe atopic dermatitis

November 20, 2023
Medical Communications Almirall, Dermatology, Ebglyss, European Commission, atopic dermatitis

Almirall has announced that the European Commission (EC) has approved Ebglyss (lebrikizumab) for the treatment of adult and adolescent patients …

Astellas Pharma to acquire Propella Therapeutics for $175m

November 20, 2023
Business Services Astellas Pharma, Oncology, Properlla Therapeutics, acquisition

Astellas Pharma and Propella Therapeutics have announced that Astellas and Propella have entered a merger agreement in which Astellas will …

FDA approves AstraZeneca’s Truqap plus Faslodex for breast cancer treatment

November 17, 2023
Medical Communications AstraZeneca, FDA, Faslodex, Oncology, breast cancer

AstraZeneca has announced that the US Food and Drug Administration (FDA) has approved Truqap (capivasertib) in combination with Faslodex (fullvestrant) …

FDA approves Merck’s Keytruda for gastric cancer treatment

November 17, 2023
Medical Communications FDA, MSD, Merck, Oncology, gastric cancer, keytruda

Merck, known as MSD outside of the US, has announced that the US Food and Drug Administration (FDA) has approved …

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