fda

Novartis receives third FDA approval for oral Fabhalta (iptacopan) the first and only treatment approved in C3 glomerulopathy (C3G)Novartis receives third FDA approval for oral Fabhalta (iptacopan) the first and only treatment approved in C3 glomerulopathy (C3G)

Novartis receives third FDA approval for oral Fabhalta (iptacopan) the first and only treatment approved in C3 glomerulopathy (C3G)

Novartis receives third FDA approval for oral Fabhalta® (iptacopan) – the first and only treatment approved in C3 glomerulopathy (C3G)…

1 month ago
Bavarian Nordic Receives U.S. FDA Approval of Chikungunya Vaccine for Persons Aged 12 and OlderBavarian Nordic Receives U.S. FDA Approval of Chikungunya Vaccine for Persons Aged 12 and Older

Bavarian Nordic Receives U.S. FDA Approval of Chikungunya Vaccine for Persons Aged 12 and Older

First chikungunya vaccine approved for persons as young as 12 years old, addressing an unmet need for chikungunya prevention for…

3 months ago
UPDATE: SpringWorks Therapeutics Announces FDA Approval of GOMEKLI (mirdametinib) for the Treatment of Adult and Pediatric Patients with NF1-PNUPDATE: SpringWorks Therapeutics Announces FDA Approval of GOMEKLI (mirdametinib) for the Treatment of Adult and Pediatric Patients with NF1-PN

UPDATE: SpringWorks Therapeutics Announces FDA Approval of GOMEKLI (mirdametinib) for the Treatment of Adult and Pediatric Patients with NF1-PN

– GOMEKLI is the first and only medicine approved for both adults and children with NF1-PN – – Approval based on…

3 months ago
SpringWorks Therapeutics Announces FDA Approval of GOMEKLI (mirdametinib) for the Treatment of Adult and Pediatric Patients with NF1-PNSpringWorks Therapeutics Announces FDA Approval of GOMEKLI (mirdametinib) for the Treatment of Adult and Pediatric Patients with NF1-PN

SpringWorks Therapeutics Announces FDA Approval of GOMEKLI (mirdametinib) for the Treatment of Adult and Pediatric Patients with NF1-PN

– GOMEKLI is the first and only medicine approved for both adults and children with NF1-PN – – Approval based on…

3 months ago
Roche receives FDA approval for the first companion diagnostic to identify patients with HER2-ultralow metastatic breast cancer eligible for ENHERTURoche receives FDA approval for the first companion diagnostic to identify patients with HER2-ultralow metastatic breast cancer eligible for ENHERTU

Roche receives FDA approval for the first companion diagnostic to identify patients with HER2-ultralow metastatic breast cancer eligible for ENHERTU

As seen in the DESTINY-Breast06 trial, approximately 20-25 percent of hormone receptor (HR)-positive, HER2-negative breast cancer patients may be considered…

3 months ago
FDA Authorizes All ZYN Nicotine Pouch Products Currently Marketed by Swedish Match in the U.S.FDA Authorizes All ZYN Nicotine Pouch Products Currently Marketed by Swedish Match in the U.S.

FDA Authorizes All ZYN Nicotine Pouch Products Currently Marketed by Swedish Match in the U.S.

FDA decision makes ZYN the first authorized nicotine pouch productScience-based decision affirms that ZYN nicotine pouches are a better alternative…

3 months ago
MediBeacon Transdermal GFR System Receives FDA Approval to Assess Kidney FunctionMediBeacon Transdermal GFR System Receives FDA Approval to Assess Kidney Function

MediBeacon Transdermal GFR System Receives FDA Approval to Assess Kidney Function

Transdermal GFR System (TGFR) is a first-in-kind product for point of care assessment of kidney function in patients with normal…

3 months ago
MediBeacon Transdermal GFR System Receives FDA Approval to Assess Kidney FunctionMediBeacon Transdermal GFR System Receives FDA Approval to Assess Kidney Function

MediBeacon Transdermal GFR System Receives FDA Approval to Assess Kidney Function

Transdermal GFR System (TGFR) is a first-in-kind product for point of care assessment of kidney function in patients with normal…

3 months ago
MediBeacon Transdermal GFR System Receives FDA Approval to Assess Kidney FunctionMediBeacon Transdermal GFR System Receives FDA Approval to Assess Kidney Function

MediBeacon Transdermal GFR System Receives FDA Approval to Assess Kidney Function

Transdermal GFR System (TGFR) is a first-in-kind product for point of care assessment of kidney function in patients with normal…

4 months ago
MediBeacon Transdermal GFR System Receives FDA Approval to Assess Kidney FunctionMediBeacon Transdermal GFR System Receives FDA Approval to Assess Kidney Function

MediBeacon Transdermal GFR System Receives FDA Approval to Assess Kidney Function

Transdermal GFR System (TGFR) is a first-in-kind product for point of care assessment of kidney function in patients with normal…

4 months ago
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