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Showing 15 posts of 1340 posts found.

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 …

News

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, …

News

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 …

News

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 …

News

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 …

News

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 …

News
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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 …

News
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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 …

News
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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 …

News

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 …

News

FDA grants Priority Review for Takeda’s cTTP treatment

May 17, 2023
Research and Development Biologics License Application, Cardiology, FDA, Takeda, cTTP

Japanese biopharmaceutical company Takeda has announced that the US Food and Drug Administration (FDA) has accepted its Biologics License Application …

News
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FDA approves new nonhormonal medication for menopause hot flashes

May 15, 2023
Medical Communications FDA, HRT, Veozah, hot flashes, menopause

The US Food and Drug Administration (FDA) has announced its approval of Veozah (fezolinetant), an oral medication to treat moderate …

News

FDA relaxes blood donation regulations for MSM

May 12, 2023
Medical Communications FDA, HIV, HIV/AIDS, blood donation

The US Food and Drug Administration (FDA) has released updated guidance for blood donation which relaxes the rules for donations …

News

FDA advisory committee votes in support of favourable benefit-risk profile for ARS Pharmaceuticals’ allergic reaction treatment

May 12, 2023
Research and Development ARS Pharmaceuticals, Allergic Disorders, FDA, allergy

US-based biopharmaceutical company ARS Pharmaceuticals has announced that the US Food and Drug Administration (FDA)’s Pulmonary-Allergy Drug Advisory Committee (PADAC) …

News

FDA advisory committee votes in favour of OTC contraceptive pill

May 11, 2023
Medical Communications Contraception, FDA, OTC, Perrigo, contraception

Perrigo Company has announced that the US Food and Drug Administration’s (FDA) Nonprescription Drugs Advisory Committee (NDAC) and the Obstetrics, …

News

Latest content

FDA grants ODD to Nexcella’s NXC-201 as treatment for amyloid light chain amyloidosis

September 22, 2023

AstraZeneca and Daiichi Sankyo’s datopotamab deruxtecan performs well in phase 3 trial

September 22, 2023

Novo Nordisk partners with UNICEF to prevent global childhood obesity

September 21, 2023

EC approves Menarini Group’s Orserdu for breast cancer treatment

September 21, 2023

Pharmanovia acquires CNS portfolio from Sanofi

September 20, 2023