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Sanofi Announces U.S FDA Acceptance of Dupixent® (dupilumab) Application for Review
Wednesday, March 08, 2023The US Food and Drug Administration FDA has accepted for review the supplemental Biologics Licence Application sBLA for Dupixent dupilumab to treat adults and adolescents aged years and older with chronic spontaneous urticaria CSU that is not adequa...
Exscientia Announces Collaboration with Charité
Wednesday, March 08, 2023Exscientia announced a new collaboration with Charit University Medicine Berlin Charit to utilise Exscientias AIdriven precision medicine platform in haematological cancers Under the collaboration Charit will evaluate the potential of Exscientias pr...
Virax Biolabs Introduces Real-Time PCR Test Kit
Wednesday, March 08, 2023Virax Biolabs Group Limited announced that it has entered into an agreement for the distribution of an Avian Influenza A Virus AIV realtime PCR test kit to markets accepting the CE mark namely the European Union The test kit is for the detection and...
Coherus BioSciences Announces US FDA Approval of UDENYCA® Autoinjector
Tuesday, March 07, 2023Coherus BioSciences announced that the US Food and Drug Administration FDA approved a singledose prefilled autoinjector presentation of UDENYCA pegfilgrastimcbqv a biosimilar pegfilgrastim administered the day after chemotherapy to decrease the incid...
Heron Therapeutics Announces U.S. Commercial Launch of APONVIE™
Tuesday, March 07, 2023Heron Therapeutics announced APONVIE aprepitant injectable emulsion is now commercially available for intravenous IV use in adults for the prevention of PONV The launch of APONVIE will now allow providers to prevent PONV without the limitations of th...
Sun Pharma Completes Acquisition of Concert Pharmaceuticals
Tuesday, March 07, 2023Sun Pharmaceutical announced the successful completion of its acquisition of Concert Pharmaceuticals for the development of deuruxolitinib a novel deuterated oral JAK inhibitor for the potential treatment of adult patients with moderate to severe alo...
FDA Accepts Eisai and Biogen Supplemental Biologics Licence Application
Monday, March 06, 2023Eisai and Biogen announced that the US Food and Drug Administration FDA has accepted Eisais supplemental Biologics Licence Application sBLA for LEQEMBI lecanemabirmb mgmL injection for intravenous use supporting the conversion of the accelerated app...
Ractigen Therapeutics Receives FDA Orphan Drug Designation for the Novel Oligonucleotide Conjugate RAG-17
Friday, March 03, 2023Ractigen Therapeutics announced that the US Food and Drug Administration FDA has granted Orphan Drug Designation to RAG a novel siRNA modality for the treatment of Amyotrophic Lateral Sclerosis ALS The approval of RAG to ALS patients can show signifi...
U.S. FDA Broadens Indication for Verzenio® (abemaciclib)
Friday, March 03, 2023Eli Lilly and Company announced that the US Food and Drug Administration FDA approved an expanded indication for Verzenio abemaciclib in combination with endocrine therapy ET for the adjuvant treatment of adult patients with hormone receptorpositive...
The Bristol Myers Squibb-Janssen Collaboration Launches Pivotal Phase 3 Librexia Clinical Trial Programme
Thursday, March 02, 2023Bristol Myers Squibb in collaboration with Janssen Pharmaceuticals Inc one of the Janssen Pharmaceutical Companies of Johnson and Johnson Janssen announced the launch of the Phase Librexia programme studying milvexian an investigational oral factor...