FDA
Rocket Pharmaceuticals granted FDA RMAT designation for gene therapy
May 24, 2023Medical 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 …
More infections from contaminated eyedrops increase death toll
May 23, 2023Medical 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, 2023Research 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, 2023Medical 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, 2023Medical 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 …
FDA approves new insulin pump and algorithm software for enhanced automated insulin delivery
May 22, 2023Medical 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 …
Swing Therapeutics receives FDA authorisation for digital therapeutic for fibromyalgia
May 22, 2023Medical 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 …
Krystal Biotech secures FDA approval for redosable topical gene therapy
May 22, 2023Medical 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 …
FDA committee votes in favour of Pfizer’s RSV vaccine for maternal immunisation
May 19, 2023Research 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, 2023Research 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 …
FDA grants Priority Review for Takeda’s cTTP treatment
May 17, 2023Research 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 …
FDA approves new nonhormonal medication for menopause hot flashes
May 15, 2023Medical 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 …
FDA relaxes blood donation regulations for MSM
May 12, 2023Medical 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 …
FDA advisory committee votes in support of favourable benefit-risk profile for ARS Pharmaceuticals’ allergic reaction treatment
May 12, 2023Research 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) …
FDA advisory committee votes in favour of OTC contraceptive pill
May 11, 2023Medical 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, …
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