Pfizer Inc. announced positive topline progression-free (PFS) survival results from Cohort 3, a separate randomized cohort of the pivotal BREAKWATER trial, evaluating Braftovi (encorafenib) in combination with cetuximab… read more.
AbbVie announced that it has received marketing approval in Japan for Aquipta tablets (atogepant), a calcitonin gene-related peptide (CGRP) receptor antagonist, for the prevention of migraine attacks in… read more.
A universal respiratory syncytial virus (RSV) immunization program using Beyfortus (nirsevimab) was associated with a statistically significant reduction in RSV-related hospitalizations in the second RSV season among infants… read more.
BioXcel Therapeutics Inc. announced the completion of an updated market opportunity assessment for Igalmi (dexmedetomidine) for acute agitation associated with bipolar disorders or schizophrenia in the at-home (outpatient)… read more.
Iovance Biotherapeutics Inc. announced data demonstrating a best-in-class profile for commercial Amtagvi (lifileucel) with unprecedented response rates in a real-world clinical, retrospective study in patients with advanced (unresectable… read more.
Moderna Inc. announced that the UK Medicines and Healthcare products Regulatory Agency (MHRA) has authorised its updated COVID-19 mRNA vaccine, Spikevax targeting the SARS-CoV-2 LP.8.1 variant, for adults… read more.
Novocure announced that the FDA approved Optune Pax, Tumor Treating Fields (TTFields) device for the treatment of adult patients with locally advanced pancreatic cancer concomitant with gemcitabine and… read more.
Citius Oncology Inc., the oncology-focused subsidiary of Citius Pharmaceuticals Inc. announced that it has entered into an exclusive distribution agreement with Uniphar , a leading international healthcare services… read more.
PTC Therapeutics Inc. announced that it has withdrawn the New Drug Application (NDA) resubmission for Translarna (ataluren) for the treatment of nonsense mutation Duchenne muscular dystrophy (DMD) following… read more.
Biofrontera Inc. announced that the FDA has completed its filing review and accepted filing of the Company’s supplemental New Drug Application (sNDA) for Ameluz (aminolevulinic acid hydrochloride) topical… read more.
Ono Pharmaceutical Co., Ltd. announced that the FDA has accepted for filing the New Drug Application (NDA) under the accelerated approval pathway for tirabrutinib, a highly selective irreversible,… read more.
Pfizer Inc. announced positive results from Cohort 3, a separate randomized cohort of the pivotal BREAKWATER trial, evaluating Braftovi (encorafenib) in combination with cetuximab (Erbitux) and FOLFIRI (fluorouracil,… read more.
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