FDA

The World Health Organization (WHO) has unveiled a set of guidelines aimed at ensuring ethical collection, access, usage, and sharing of human genomic data. Developed with input from the WHO Technical Advisory Group on Genomics (TAG-G) and a panel of […]

**Kura Oncology, Inc., a biopharmaceutical company specializing in clinical-stage drug development, and Kyowa Kirin Co., Ltd., an international specialty pharmaceutical firm, have announced a global partnership.** The agreement focuses on developing and marketing ziftomenib, Kura’s selective oral menin inhibitor, currently

Maypharm’s distinctive strategy targets high-entry-barrier markets with bespoke business models, setting itself apart within a competitive and highly regulated environment. The company emphasizes niche, region-specific products like Metamizole, alongside complex injectables, pioneering generics, and advanced drug delivery systems, to cultivate

Novartis has revised its mid-term performance outlook ahead of its Meet Novartis Management event for financial stakeholders in London. The initial guidance of +5% sales CAGR from 2023 to 2028 has been adjusted to +6%, fueled by the current momentum

**BioLineRx Ltd., a biopharmaceutical firm focused on transformative treatments for cancer and uncommon medical conditions, and Ayrmid Ltd., the umbrella organization of Gamida Cell Ltd., revealed their new licensing arrangement on November 20, 2024. The agreement is set to advance

A groundbreaking study has shed light on how a seldom-seen genetic anomaly can disrupt brain cell interactions, offering vital understanding of its role in a major neurological condition called developmental and epileptic encephalopathy (DEE). Insights from the research show that

Jazz Pharmaceuticals plc has announced that the US Food and Drug Administration (FDA) has expedited the approval of Ziihera (zanidatamab-hrii) 50mg/mL for intravenous administration. This approval targets adults with previously treated, unresectable, or metastatic HER2-positive (IHC 3+) biliary tract cancer

The World Health Organization (WHO) has approved Emergency Use Listing (EUL) for the LC16m8 mpox vaccine. This marks it as the second vaccine endorsement by WHO after the August 14, 2024, declaration of an mpox international public health emergency by

Syngene has commenced a bioequivalence study on an injectable intended for type-2 diabetes and weight regulation, following the approach of a global pharmaceutical firm seeking to partner for outsourced human pharmacological studies of semaglutide. The reference medication, Ozempic, is used

In an effort to enhance the clarity and efficiency of the approval process for manufacturing licenses in medical device sectors, the central government is planning revisions to the Medical Device Rules (MDR), 2017. These changes will incorporate specific timelines related