EMA’s CHMP recommends Sanofi’s Sarclisa approval for multiple myeloma
The European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has recommended the approval of ...
InflaRx Receives Positive CHMP Opinion for GOHIBIC® (Vilobelimab) for the Treatment of SARS-CoV-2-Induced Acute Respiratory Distress Syndrome
InflaRx N.V. (Nasdaq: IFRX), a biopharmaceutical company pioneering anti-inflammatory therapeutics targeting the complement system, today announced that the Committee for Medicinal Products for Human ...
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EMA rethinks stance, committee now recommends Leqembi for Alzheimer’s disease
Following a re-evaluation, the EMA has recommended Eisai and Biogen’s Alzheimer’s therapy Leqembi for a subgroup of patients.
European committee takes a second look at Alzheimer's drug and now says it should be approved
A European regulatory committee now recommends approval of the Alzheimer’s treatment lecanemab a few months after rejecting ...
Bristol Myers Gets CHMP Backing for Augtyro Cancer Drug
Bristol Myers Squibb on Friday said the European Medicines Agency's Committee for Medicinal Products for Human Use recommended expanded approval of its Augtyro cancer drug in a pair of indications.
Eisai Gets Positive Opinion From CHMP In European Union For Lecanemab In Early Alzheimer's Disease
Eisai Co., Ltd. (ESALF.PK) and Biogen Inc. (BIIB) announced a positive opinion has been received from the Committee for Medicinal ...
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Eisai Receives Positive Opinion from the CHMP in the European Union for Lecanemab in Early Alzheimer’s Disease
Eisai Europe Ltd. and Biogen Inc. announced today that a positive opinion has been received from the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) ...
InflaRx receives positive CHMP opinion for SARS-CoV-2-induced acute respiratory distress treatment
InflaRx N.V.  (NASDAQ:IFRX) announced Friday that an expert panel of the EU drug regulator, the European Medicines Agency (EMA), endorsed vilobelimab for SARS-CoV-2-induced acute respiratory distress.
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EMA's CHMP Now Recommends Approval for Eisai, Biogen's Alzheimer's Drug Leqembi in Europe
The agency had previously recommended against marketing authorization for the Alzheimer's disease but reconsidered after a review.
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Leqembi: Side Effects No Worse in Clinical Use Than They Were in Trial
An estimated 4,500 prescriptions have been filled in 2024 so far, Iwatsubo said. About 80 percent of patients have mild cognitive impairment, the rest have mild dementia. Most are in their 70s, and ...
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Use of herbal medicinal products among patients in primary health care in a Brazilian southeastern city: evidence from the Prover project
Herbal medicinal product use was 3.8%, with high formal prescription; however, it is accompanied by a high risk of interactions and redundancy. Unified Health System pharmacies are not the main source ...