AstraZeneca and Daiichi Sankyo have secured breakthrough therapy designation from the US Food and Drug Administration (FDA) for its Enhertu to treat patients with HER2-positive unresectable or metastatic gastric or gastroesophageal junction adenocarcinoma who have received two or more prior regimens including trastuzumab.
Novartis has secured approval from the US Food and Drug Administration (FDA) for its Tabrecta (capmatinib) to treat adult patients metastatic non-small cell lung cancer (NSCLC) with MET exon 14 skipping (METex14).
The US Food and Drug Administration (FDA) has given its emergency use authorisation (EUA) for Gilead Sciences' investigational antiviral remdesivir for the treatment of Covid-19.
Banner Life Sciences, a privately held specialty pharmaceutical company, announced that the U.S. Food and Drug Administration (FDA) granted final approval of BAFIERTAM (monomethyl fumarate) delayed-release capsules for the treatment of relapsing forms of multiple sclerosis (MS).
GlaxoSmithKline announced the US Food and Drug Administration (FDA) approved the company’s supplemental New Drug Application (sNDA) for Zejula (niraparib), an oral, once-daily poly (ADP-ribose) polymerase (PARP) inhibitor, as a monotherapy maintenance treatment for women with advanced epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in a complete or partial response to first-line platinum-based chemotherapy, regardless of biomarker status.
Merck said that the US Food and Drug Administration (FDA) has given its approval for the use of its cancer drug KEYTRUDA (pembrolizumab) at an additional dosage of 400mg every six weeks (Q6W) across all indications in adult patients.
Takeda Pharmaceutical has secured breakthrough therapy status from the US Food and Drug Administration (FDA) for its investigational drug mobocertinib (TAK-788) to treat patients with metastatic non-small cell lung cancer (NSCLC).
French drugmaker Sanofi has secured approval from the US Food and Drug Administration (FDA) for its MenQuadfi meningococcal vaccine.
Novartis has secured regenerative medicine advanced therapy (RMAT) designation from the US Food and Drug Administration (FDA) for its Kymriah (tisagenlecleucel) for an investigational new indication to treat patients with relapsed or refractory (r/r) follicular lymphoma (FL).
Nexus Pharmaceuticals announced that has received U.S. Food and Drug Administration (FDA) approval for its patent-pending New Drug Application (NDA) Emerphed, the first and only premixed ephedrine in a ready-to-use 50 mg/10 mL vial. With no need for compounding, diluting, or mixing, Emerphed saves valuable staff time while also reducing the potential for preparation error and waste.
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