FDA approves Innoviva’s Xacduro for intravenous use

May 24, 2023
Medical Communications FDA, Infections and infestations, Innoviva, pneumonia

Innoviva Specialty Therapeutics, a subsidiary of Innoviva, has announced that the US Food and Drug Administration (FDA) has approved Xacduro …

Rocket Pharmaceuticals granted FDA RMAT designation for gene therapy

May 24, 2023
Medical Communications FDA, Haematology, RMAT, Rocket Pharmaceuticals, gene therapy

Rocket Pharmaceuticals, a US-based biotechnology company, has announced that it has received US Food and Drug Administration (FDA) Regenerative Medicine …

Touchlight completes expansion of one of world’s largest DNA manufacturing facilities in London

May 24, 2023
Manufacturing and Production DNA, London, Manufacturing Facility, Touchlight, manufacturing

Touchlight, a company that focuses on pioneering enzymatic DNA production, has announced that it has completed the redevelopment and expansion …

More infections from contaminated eyedrops increase death toll

May 23, 2023
Medical Communications FDA, Opthalmology, eyedrops, infections

The US Centers for Disease Control and Prevention (CDC) have released updated data regarding contaminated eyedrops. As of May 2023, …

FDA announces acceptance and priority review of NDA for LUMISIGHT imagining agent for breast cancer

May 23, 2023
Research and Development FDA, Lumicell, Oncology, breast cancer, oncology

Lumicell has announced that the US Food and Drug Administration (FDA) has accepted and granted priority review for the New …

Grünenthal receives FDA Breakthrough Therapy Designation for knee osteoarthritis drug

May 23, 2023
Medical Communications Breakthrough Therapy Designation, FDA, Grunenthal, Musculo-skeletal disorder, osteoarthritis

German pharmaceutical company Grünenthal has announced that the US Food and Drug Administration (FDA) has awarded it Breakthrough Therapy Designation …

FDA approves prescription nasal spray for opioid overdose treatment

May 23, 2023
Medical Communications FDA, Nasal Spray, Opvee, Poisoning and drug dependency, opioids, overdose

The US Food and Drug Administration (FDA) has announced that it has approved Opvee, the first nalmefene hydrochloride nasal spray …

Oncimmune Holdings sells businesses to Freenome in £13m deal

May 22, 2023
Sales and Marketing Freenome, Oncimmune Holdings, Oncology, acquisition

UK-based life sciences and immunodiagnostics firm Oncimmune Holdings has announced that it has sold its Oncimmune Limited and Oncimmune Europe …

FDA approves new insulin pump and algorithm software for enhanced automated insulin delivery

May 22, 2023
Medical Communications Devices, FDA, diabetes, insulin

The US Food and Drug Administration (FDA) has announced that it has cleared the Beta Bionics iLet ACE Pump and …

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Swing Therapeutics receives FDA authorisation for digital therapeutic for fibromyalgia

May 22, 2023
Medical Communications CBT, Devices, FDA, Swing Therapeutics, fibromyalgia

Swing Therapeutics has announced that it has received De Novo marketing authorisation from the US Food and Drug Administration for …

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Krystal Biotech secures FDA approval for redosable topical gene therapy

May 22, 2023
Medical Communications FDA, Krystal Biotech, Paediatrics, dystrophic epidermolysis bullosa, gene therapy

US-based biotech company Krystal Biotech has announced that the US Food and Drug Administration (FDA) has approved its topical gene …

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FDA committee votes in favour of Pfizer’s RSV vaccine for maternal immunisation

May 19, 2023
Research and Development FDA, Immunology, Pfizer, RSV, Vaccine, maternal immunisation

Pfizer has announced that the Vaccines and Related Biological Products Advisory Committee (VRBPAC) from the US Food and Drug Administration …

FDA approves Abbott’s Assert-IQ insertable cardiac monitor

May 19, 2023
Research and Development Abbott, Cardiology, Devices, FDA, heart monitor, medical devices

Abbott has announced that the US Food and Drug Administration (FDA) has granted its clearance for the Assert-IQ insertable cardiac …

Schott Pharma announces pre-filled polymer syringes for deep-cold medication

May 19, 2023
Medical Communications Devices, Schott Pharma, deep cold medication, syringe

Germany-based drug delivery solutions company Schott Pharma has announced its pre-fillable syringes (PFS) for drugs requiring deep-cold, such as those …

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NHS given guidance on offering genetic testing to stroke patients

May 19, 2023
Medical Communications NHS, Neurology, blood clot, genetic testing, stroke

The NHS has been given draft guidance on offering gene tests to patients who have had a stroke caused by …

Is the pharmaceutical sector prepared to face a titanium dioxide ban?

May 19, 2023
Manufacturing and Production ACG, EMA, EU, Titanium Dioxide

Dr Subhashis Chakraborty, head of Global Product Management, ACG Capsules In the wake of the ban on titanium dioxide (TiO2) …

NICE recommends Kapruvia for treatment of moderate-to-severe CKD-associated pruritus

May 18, 2023
Medical Communications Kapruvia, NICE, Nephrology, chronic kidney disease, pruritus

Vifor Fresenius Medical Care Renal Pharma (VFMCRP) and Cara Therapeutics have announced that the National Institute for Health and Care …

US appeals court hears arguments in abortion pill case

May 18, 2023
Medical Communications Obstetrics & Gynaecology, abortion, medication abortion, mifepristone, reproduction

The ongoing court battle surrounding the contested approval of mifepristone, one of the drugs used in medication abortions, has now …

Servier and Aitia enter into R&D collaboration for pancreatic cancer using Digital Twins

May 18, 2023
Research and Development Aitia, Digital Twins, Oncology, Pancreatic cancer, Servier

French pharmaceutical company Servier and US-based Causal AI and Digital Twins company Aitia have announced a collaboration to create Digital …

Asieris Pharmaceuticals and Uroviu announce strategic collaboration to further develop integrated diagnosis and treatment for bladder cancer

May 18, 2023
Research and Development Asieris Pharmaceuticals, Diagnostics, Oncology, Uroviu, bladder cancer, oncology

US-based biopharmaceutical company Asieris Pharmaceuticals and single-use endoscopic platform creator Uroviu have announced that they have entered into a strategic …

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