GSK's Jemperli Gains EU Nod for First-Line Treatment of Endometrial Cancer

GSK plc announced that the European Commission has authorized Jemperli (dostarlimab) in conjunction with chemotherapy (carboplatin and paclitaxel) as a first-line therapy for adult patients with primary advanced or recurrent endometrial cancer...

Strides Pharma Bags USFDA Nod for OTC Acetaminophen-Ibuprofen Combo Tablets

Strides Pharma Science Limited has announced that its wholly owned subsidiary, Strides Pharma Global Pte Limited, Singapore, has obtained approval from the United States Food & Drug Administration (USFDA) for Acetaminophen and Ibuprofen Tablets...

US FDA Approves Amgen's Lumakras-Vectibix Combo for KRAS G12C-Mutated mCRC

Amgen announced that the US Food and Drug Administration (FDA) has granted approval for Lumakras (sotorasib) in conjunction with Vectibix (panitumumab) for treating adult patients with KRAS G12C-mutated metastatic colorectal cancer (mCRC)...

AstraZeneca's Calquence Combo Secures US Nod for Mantle Cell Lymphoma

AstraZeneca's Calquence (acalabrutinib), combined with bendamustine and rituximab, has received approval in the US for treating adult patients with previously untreated mantle cell lymphoma (MCL) who cannot undergo autologous hematopoietic stem...

Zydus Bags USFDA Nod for Phase II(b) Trial to Optimize Usnoflast Dosage

Indian pharmaceutical company Zydus has been granted approval by the USFDA to perform a Phase II(b) clinical trial aimed at identifying the ideal dosage strength of Usnoflast, an innovative oral NLRP3 inflammasome inhibitor for individuals with...

US FDA Approves Alcresta's RELiZORB for Children Aged 1

Alcresta Therapeutics, Inc., a prominent company in the commercial stage that specializes in creating and marketing innovative enzyme-based products, announced that the US Food and Drug Administration (FDA) has approved the expanded utilization of...

Eli Lilly's Omvoh Bags FDA Nod to treat Crohn's disease in Adults

Eli Lilly and Company announced that the US Food and Drug Administration (FDA) has authorized Omvoh (mirikizumab-mrkz) for treating moderately to severely active Crohn's disease in adults. Omvoh has received approval in the US for two forms of...

Annovis Bio Secures US Patent for Buntanetap in Nerve Injury Treatment

Annovis Bio Inc., a company in the late stages of clinical drug development focused on innovative therapies for neurodegenerative disorders like Alzheimer’s disease (AD) and Parkinson’s disease (PD), revealed that it received the US patent for...

MedMira Secures Health Canada Approval for Reveal G4 Rapid HIV Test

MedMira Inc. (MedMira) announced that it has secured approval from Health Canada for its Reveal Rapid G4 HIV-1/2 Test (Reveal HIV test) intended for Point-of-Care (POC) applications. The Reveal HIV rapid test boasts a sensitivity of 99.64% and a...

Alembic Pharma Secures USFDA Nod for Generic Brexpiprazole Tablets

Alembic Pharmaceuticals Ltd announced that it has secured final approval from the US health regulator for its generic variant of Brexpiprazole tablets, which are used in treating major depressive disorder. The company announced that the US Food &...