Eisai Co., Ltd. and nippon medac Co., Ltd., a subsidiary of medac Gesellschaft für klinische Spezialpräparate mbH announced that they have obtained manufacturing and marketing approval from the… read more.
Positive high-level results from the LAURA Phase III trial showed AstraZeneca’s Tagrisso (osimertinib) demonstrated a statistically significant and highly clinically meaningful improvement in progression-free survival (PFS) for patients… read more.
The biologics license application (BLA) for the interleukin (IL)-2–based immunotherapy denileukin diftitox (Lymphir) in patients with relapsed or refractory cutaneous T-cell lymphoma (CTCL) following at least 1 prior… read more.
The FDA has accepted a biologics license application (BLA) for Alvotech’s ustekinumab biosimilar candidate (AVT 04) referencing Stelara, which will be used to treat several autoimmune disorders. Alvotech… read more.
Roche announced that the FDA has approved Xolair (omalizumab) for the reduction of allergic reactions, including anaphylaxis, that may occur with accidental exposure to one or more foods… read more.
Insulet Corporation ,the global leader in tubeless insulin pump technology with its Omnipod brand of products, announced it has received CE mark approval under the European Medical Device… read more.
AIM ImmunoTech Inc. announced positive topline results from the Company’s Phase II study evaluating the efficacy and safety of Ampligen as a potential therapeutic for people with the… read more.
Biogen Inc. announced the European Commission (EC) has authorized Skyclarys (omaveloxolone) for the treatment of Friedreich’s ataxia (FA) in adults and adolescents aged 16 years and older …. read more.
GSK plc announced that the Center for Drug Evaluation (CDE) of the China National Medical Products Administration (NMPA) has accepted for review the regulatory application of Shingrix (Recombinant… read more.
Boston Scientific Corporation announced that the FDA has approved an expanded indication of the WaveWriter SCS Systems for the treatment of chronic low back and leg pain in… read more.
GSK plc announced that the FDA has accepted under priority review an application to extend the indication of GSK’s adjuvanted respiratory syncytial virus (RSV) vaccine to adults aged… read more.
AbbVie has announced that Vyalev (foslevodopa/foscarbidopa solution) is now available for the treatment of motor fluctuations in patients with advanced levodopa-responsive Parkinson’s disease who do not have satisfactory… read more.
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