with first data readout expected in summer 2025 European Committee for Medicinal Products for Human Use (CHMP) review of ...

Applied Therapeutics, Inc. (Nasdaq: APLT) (the“Company”), a clinical-stage biopharmaceutical company developing a pipeline of novel drug candidates against validated molecular targets in indications ...

BeiGene's TEVIMBRA expands for cancer treatment, and BRUKINSA sales soar 107%. See why BGNE stock presents upside potential ...

Moreover, a negative opinion from the Committee for Medicinal Products for Human Use (CHMP) has impacted prospects. They also ...

PTC Therapeutics' NDA resubmission of Translarna was based on data from Study 041 and the long-term STRIDE registry. No PDUFA action date was provided for regulators.

The European Commission has approved the Committee for Medicinal Products for Human Use (CHMP) recommendation to change the terms of marketing authorization for Fasenra (benralizumab). It can now ...

Four months after the Committee for Medicinal Products for Human Use (CHMP) rejected Apellis’ GA application for Syfovre for a second time, Astellas has withdrawn its application for the ...

The Committee for Medicinal Products for Human Use (CHMP) has recommended that the drug be used in combination with an aromatase inhibitor as an adjuvant treatment for adults with hormone receptor (HR ...

In February, the CHMP said it was minded to reject Orphazyme's application for arimoclomol, intended as a treatment for a third type of ASMD – Niemann-Pick disease type C – saying it would ...

LINDIS Biotech GmbH, a biopharmaceutical company with a proprietary multi-specific antibody platform and an advanced development pipeline in immuno-oncology, announced that the Committee for Medicinal ...

BeiGene, Ltd., a global oncology company, announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency issued positive opinions recommending an extended ...

The Committee for Medicinal Products for Human Use (CHMP) has specifically recommended that the drug be used to treat patients with stage one or two polyneuropathy (PN), a condition that affects ...