Samsung Bioepis Receives Positive CHMP Opinion for Denosumab Biosimilars, OBODENCE™ and XBRYK™
OBODENCE™ and XBRYK™ recommended for approval by the European Medicines Agency for all indications referencing Prolia and Xgeva, respectivelyINCHEON, South Korea, Nov. 15, 2024 (GLOBE NEWSWIRE) -- Co ...
InflaRx Shares Rise 12% After Regulators Favor Authorization of Gohibic
InflaRx shares rose 12% in premarket trading after regulators issued a positive opinion recommending marketing authorization of Gohibic. Shares on Friday were trading around $2.27. The stock is up 25% ...
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 ...
MHRA calls for industry input on keeping EU law, IVD classification & more
The UK’s Medicines and Healthcare Products Regulatory Agency (MHRA) has launched a consultation period calling on the public ...
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.
News Medical10h
Tirzepatide significantly reduces weight and diabetes risk in patients with obesity and prediabetes
Tirzepatide shows promise in reducing weight and preventing diabetes progression in people with obesity and prediabetes, with ...
Ticker: Biogen Alzheimer’s drug gets second look in EU; Ford takes $165M hit on slow recall
A European regulatory committee now recommends approval of the Alzheimer’s treatment lecanemab a few months after rejecting ...
EU regulator reverses decision to block Alzheimer's drug lecanemab
The European Union's drugs regulator reversed its decision to block the Alzheimer's drug lecanemab, a treatment aimed at ...
BioPharma Dive16h
Eisai wins over European regulators on Alzheimer’s drug Leqembi
A key regulatory committee sided against the drug this summer. But an appeal from Eisai appears to have worked, teeing Leqembi up for authorization in a major market.
Eisai receives positive CHMP opinion for Lecanemab in early Alzheimer’s disease
Eisai (ESAIY) and Biogen (BIIB) announced that a positive opinion has been received from the Committee for Medicinal Products for Human Use of ...
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 ...
Biogen’s stock rises after E.U. regulator reverses negative view of Alzheimer’s drug
Biogen’s stock rose 1% Thursday, after Europe’s pharmaceutical regulator issued a positive opinion on the Alzheimer’s disease ...