Regulation

Aadi Bioscience initiates rolling submission of NDA to FDA for nab-sirolimus for advanced malignant PEComa

Aadi Bioscience announced that the company has initiated submission of a rolling New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for the treatment of advanced (metastatic or locally advanced) malignant PEComa (perivascular epithelioid-cell tumor) – a rare form of sarcoma driven by mTOR activation for which there is currently no approved therapy.

NeuroRx, Relief Therapeutics secure FDA fast track status for Covid-19 drug candidate

NeuroRx and Relief Therapeutics have secured fast track designation from the US Food and Drug Administration (FDA) to evaluate RLF-100 (Aviptadil) to treat acute lung injury/acute respiratory distress syndrome associated with Covid-19.

Deciphera gets Canadian approval for QINLOCK for fourth-line gastrointestinal stromal tumour

Deciphera Pharmaceuticals announced that Health Canada has authorized QINLOCK (ripretinib), a switch-control tyrosine kinase inhibitor, for sale in Canada for the treatment of adult patients with advanced gastrointestinal stromal tumor (GIST) who have received prior treatment with imatinib, sunitinib, and regorafenib.

India’s Cipla launches remdesivir generic version to treat Covid-19 disease

Indian drugmaker Cipla has introduced the generic version of remdesivir, dubbed Cipremi, to treat patients with severe Covid-19 disease.

India’s CDSCO approves generics of Favipiravir and Remdesivir for Covid-19 treatment

The Indian Central Drugs Standard Control Organisation (CDSCO) has approved the use of Glenmark Pharmaceuticals' generic for Favipiravir and Cipla and Hetero Drugs' respective generics for Remdesivir for the treatment of Covid-19 patients.

Elemental Packaging

After transferring the media slurry into the open column, the piston is quickly mounted in a way that avoids air entry, and the column is sealed.

Epizyme announces US FDA accelerated approval of TAZVERIK for relapsed/refractory follicular lymphoma

Epizyme, a fully integrated, commercial-stage biopharmaceutical company developing novel epigenetic therapies, today announced that the U.S. Food and Drug Administration (FDA) has approved the supplemental New Drug Application (sNDA) for TAZVERIK™ (tazemetostat) for the following two distinct follicular lymphoma (FL) indications.

Novartis gets FDA approval for Cosentyx to treat active non-radiographic axial spondyloarthritis

Novartis has secured approval from the US Food and Drug Administration (FDA) for its Cosentyx (secukinumab) to treat active non-radiographic axial spondyloarthritis (nr-axSpA).

Jazz, PharmaMar get FDA accelerated approval for Zepzelca in metastatic SCLC

Jazz Pharmaceuticals and PharmaMar have secured accelerated approval from the US Food and Drug Administration (FDA) for Zepzelca (lurbinectedin) for the treatment of metastatic small cell lung cancer (SCLC).