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FDA turns down Novocure’s brain metastases device
The US Food and Drug Administration (FDA) has rejected Novocure’s application for marketing approval of Optune Mya, a medical device for the treatment of brain ...
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FDA approves Bayer’s first-in-class stroke drug
The US Food and Drug Administration (FDA) has approved a new type of medicine to reduce the risk of recurrent stroke.
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Egetis sells FDA voucher for 190 million dollars
Swedish biotech Egetis Therapeutics is selling the priority review voucher it recently received following the U.S. approval of its drug Emcitate. The price tag ...
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Teva wins FDA approval for schizophrenia injection
The US Food and Drug Administration (FDA) has approved Teva’s Weltruza, the first long-acting olanzapine injection that can be administered subcutaneously once ...
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AstraZeneca wins new FDA approval for serious kidney disease
A new treatment indication has opened up for AstraZeneca’s Ultomiris following positive results from a phase III trial. The FDA has approved the drug for a rare...
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Xbrane wins long-awaited FDA approval for eye drug biosimilar
After a long and winding road, Xbrane has now received FDA approval for Lucamzi, a biosimilar to the eye drug Lucentis.
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AbbVie wins FDA approval for new Parkinson’s treatment
A new drug for Parkinson’s disease has been approved in the US
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Abbott gets FDA nod for updated heart failure system
Abbott has received approval from the U.S. Food and Drug Administration (FDA) for updates to its implantable heart monitoring system.
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Pfizer wins new FDA approval for Tukysa in breast cancer
Pfizer is strengthening its position in HER2-positive breast cancer. The FDA has approved Tukysa as a first-line maintenance treatment after a phase III trial s...
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Marie Gårdmark: Are FDA and EMA drifting apart?
Are FDA and EMA beginning to drift apart on what it takes to approve new medicines? And what could that mean for drug development on both sides of the Atlantic?...
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Multicancer blood test moves closer to FDA approval
A blood test designed to detect signals from more than 50 types of cancer before symptoms appear could be on its way to FDA approval, after an advisory panel of...
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FDA clears 3.95 million dollar gene therapy
For the first time, there is now an approved gene therapy for Sanfilippo syndrome type A. The disease is extremely rare, and the treatment is among the most exp...
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Egetis lands FDA approval: “Biggest milestone in the company’s history”
Swedish Egetis Therapeutics has secured FDA approval for its rare disease drug Emcitate, clearing the way for a US launch within weeks. “We are transitioning fr...
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FDA Breakthrough Device Designation lifts Neola shares
Lund-based Neola Medical has been granted the FDA’s Breakthrough Device Designation for Neola, the company’s medical device for continuous lung monitoring in pr...
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New FDA setback for Xspray – stock plunges
The Swedish research company Xspray Pharma has received yet another negative decision from the U.S. Food and Drug Administration (FDA), linked to the company’s ...
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Roche's Tecentriq gets FDA nod after strong colon cancer data
A combination of Tecentriq and chemotherapy cut the risk of recurrence or death by half in patients with stage III colon cancer and dMMR tumours. The results ha...
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FDA approves first SMA therapy targeting muscle loss
A new type of medication for the rare genetic disease spinal muscular atrophy (SMA) has been approved in the United States.
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Etcamah misses main goal after recent FDA approval
AstraZeneca’s tablet therapy Etcamah for breast cancer has failed to meet the primary endpoint in a Phase III study, the company reports. The announcement comes...
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Zolgensma gene therapy under investigation after tumour reports
The FDA is investigating a potential cancer risk in patients treated with Zolgensma, a gene therapy for spinal muscular atrophy (SMA).
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ZEISS CLINIC 360 receives FDA 510k clearance
The ZEISS CLINIC 360 all-in-one browser-based software solution aggregates clinical data at scale and powers advanced analytics for streamlined ophthalmic workf...
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Trump expected to pick Heidi Overton to lead the FDA
Donald Trump is expected to nominate Heidi Overton as the new commissioner of the US Food and Drug Administration (FDA), according to several international media outlets.
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FDA OKs new once-daily HIV combo pill
The U.S. Food and Drug Administration has approved a new once‑daily tablet from Gilead Sciences for the treatment of adults whose HIV infection has already been...
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Sobi gains regulatory momentum with new FDA Fast Track designation
Sobi has secured a US FDA Fast Track designation for pacritinib, advancing the drug’s development as a potential treatment for the rare and severe autoinflammat...
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Breakthrough in pancreatic cancer – new drug wins FDA approval
A new type of medicine that has shown very strong results against pancreatic cancer has been approved by the FDA through a record‑fast process.
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