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June 2, 2021

FDA Approves Ibrexafungerp for Vaginal Yeast Infection FDA Approves Ibrexafungerp for Vaginal Yeast Infection

The US Food and Drug Administration (FDA) has approved ibrexafungerp tablets (Brexafemme) as a 1-day oral therapy for vaginal yeast infections, something 3 out of every […]
June 1, 2021

Novel Drug Approved by FDA for Some Bile Duct Cancers Novel Drug Approved by FDA for Some Bile Duct Cancers

A novel drug, infigratinib (Truseltiq), is now available in the United States for adults with previously treated unresectable bile duct cancer harboring a fibroblast growth factor […]
June 1, 2021

FDA Okays New Drug Option for Schizophrenia, Bipolar I Disorder FDA Okays New Drug Option for Schizophrenia, Bipolar I Disorder

The US Food and Drug Administration (FDA) has approved a once-daily oral medication, which is a combination of olanzapine and samidorphan (Lybalvi, Alkermes), for the treatment […]
May 28, 2021

First Drug for Lung Cancer With KRAS Mutation Gains FDA Approval First Drug for Lung Cancer With KRAS Mutation Gains FDA Approval

The first drug to target KRAS mutations in non-small cell lung cancer (NSCLC) has been approved by the US Food and Drug Administration. KRAS mutations are […]
May 28, 2021

FDA Expands Rimegepant Indication to Include Migraine Prevention FDA Expands Rimegepant Indication to Include Migraine Prevention

The US Food and Drug Administration (FDA) has expanded the indication for rimegepant (Nurtec ODT, Biohaven) to include prevention of migraine in adults. Last year, rimegepant […]
May 28, 2021

FDA Approves Ozanimod (Zeposia) for Ulcerative Colitis FDA Approves Ozanimod (Zeposia) for Ulcerative Colitis

The US Food and Drug Administration (FDA) has approved ozanimod (Zeposia) for adults with moderately to severely active ulcerative colitis (UC), the company has announced. Ozanimod […]
May 25, 2021

EU Panel Likes Monotherapy Cemiplimab for Two Cancers EU Panel Likes Monotherapy Cemiplimab for Two Cancers

The immunotherapy cemiplimab (Libtayo) looks set to have two further cancer indications in Europe: nonsmall cell lung cancer (NSCLC) and basal cell carcinoma (BCC). The European […]
May 21, 2021

FDA Class I Recall of Some Boston Scientific Venous Stents FDA Class I Recall of Some Boston Scientific Venous Stents

Boston Scientific Corporation has recalled its VICI SDS and VICI RDS venous stent systems in response to reports that the stents may migrate or move from […]
May 21, 2021

FDA OKs First Targeted Therapy for Subset of Patients With NSCLC FDA OKs First Targeted Therapy for Subset of Patients With NSCLC

The US Food and Drug Administration (FDA) today granted an accelerated approval for amivantamab (Rybrevant) as the first targeted treatment for patients with non–small cell lung […]
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