Alembic Pharmaceuticals Limited has achieved a major milestone in the pharmaceutical industry. On September 27, 2024, the company proudly announced that it received final approval from the United States Food and Drug Administration (USFDA) for its Paliperidone Extended-Release Tablets in strengths of 1.5 mg, 3 mg, 6 mg, and 9 mg. This approval marks a […]
Indoco Remedies Ltd., a renowned player in the global pharmaceutical industry, has announced receiving tentative approval from the United States Food and Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) for Canagliflozin Tablets in 100 mg and 300 mg strengths. These tablets are the generic equivalent of the Reference Listed Drug, Invokana Tablets, […]
Global pharmaceutical leader, Lupin Limited, announced its significant achievement of receiving tentative approval from the United States Food and Drug Administration (U.S. FDA) for its Abbreviated New Drug Application (ANDA) for Canagliflozin Tablets, both 100 mg and 300 mg. This approval allows Lupin to market a generic equivalent of Invokana Tablets, manufactured by Janssen Pharmaceuticals, […]
The European Commission has granted a conditional marketing authorization (CMA) for the single dose Janssen Covid‑19 vaccine developed by the Janssen Pharmaceutical Companies of Johnson & Johnson. The Janssen vaccine is the fourth Covid-19 vaccine authorized in the European Union (EU) after the vaccines developed by BioNTech and Pfizer, Moderna, and AstraZeneca. Ursula von der […]
Cabenuva FDA approval : ViiV Healthcare has secured approval from the US Food and Drug Administration (FDA) for its long-acting regimen Cabenuva for the treatment of HIV-1 infection in adult patients. According to ViiV Healthcare, Cabenuva is being given as a co-pack with a couple of injectable medicines that include the company’s integrase strand transfer […]
Geographic atrophy treatment : Janssen Pharmaceuticals has signed a licensing deal to acquire rights to HMR59, an investigational gene therapy for geographic atrophy, from clinical stage ocular gene therapy company Hemera Biosciences for an undisclosed price. HMR59 is intended to be given as a one-time, outpatient, intravitreal injection for helping in preserving vision in patients […]
Johnson & Johnson (J&J) said that the European Commission (EC) has approved an advance purchase agreement for securing 200 million doses of the JNJ-78436735 Covid-19 vaccine candidate (Ad26.COV2.S) developed by its subsidiary Janssen Pharmaceutical Companies. Currently, the JNJ-78436735 vaccine candidate is being evaluated in the phase 3 ENSEMBLE Covid-19 vaccine trial across certain countries. The […]
Janssen Pharmaceutical Companies of Johnson & Johnson encountered a significant setback with their esketamine nasal spray in a phase 3 trial aimed at treating patients with treatment-resistant depression. The trial’s results revealed that esketamine did not meet its primary endpoint, sparking concern among industry experts and stakeholders. The late-stage study assessed the efficacy of two […]
The Janssen Pharmaceutical Companies of Johnson & Johnson have achieved a significant milestone with the European Commission’s approval of Darzalex (daratumumab) for use as an initial therapy in adult patients with newly diagnosed multiple myeloma who are not eligible for autologous stem cell transplant (ASCT). This approval allows for the combination of daratumumab with bortezomib, […]
Janssen Pharmaceutical, a subsidiary of Johnson & Johnson, has received approval from the US Food and Drug Administration (FDA) for its combination treatment of IMBRUVICA (ibrutinib) and rituximab for Waldenström’s macroglobulinemia (WM), a rare form of blood cancer. This latest approval expands the use of IMBRUVICA in treating WM from monotherapy to now include combination […]