Sanofi Secures EU Approval for Subcutaneous Sarclisa in Multiple Myeloma

Sanofi has received European Commission approval for subcutaneous Sarclisa, or isatuximab, in combination with standard-...

June 10, 2026 | Wednesday | News
MEDIPOST Secures FDA Agreement for CARTISTEM Phase III Strategy in US

MEDIPOST has secured FDA agreement to conduct a single pivotal Phase III study for CARTISTEM in the US, marking an impor...

June 10, 2026 | Wednesday | News
Pfizer Secures FDA Approval for Expanded Hympavzi Use in Hemophilia

Pfizer has received US FDA approval for an expanded indication of Hympavzi for hemophilia A or B, broadening its use to ...

June 10, 2026 | Wednesday | News
Shionogi Receives US FDA Approval for Oral COVID-19 Post-Exposure Prophylaxis

Shionogi has received US FDA approval for XOCOVA, or ensitrelvir, as an oral post-exposure prophylaxis option for COVID-...

June 9, 2026 | Tuesday | News
VERTANICAL Secures First European Marketing Authorisation for Exilby in Chronic Low Back Pain

VERTANICAL has received marketing authorisation in Germany for Exilby, or VER-01, for the treatment of chronic low back ...

June 9, 2026 | Tuesday | News
FDA Approves Genentech’s Tecentriq for ctDNA-Guided Adjuvant Bladder Cancer Treatment

Genentech has received US FDA approval for Tecentriq and Tecentriq Hybreza as adjuvant treatment for adults with muscle-...

June 8, 2026 | Monday | News
EMA Accepts Teva and Medincell’s MAA for Monthly Olanzapine Long-Acting Injectable

The European Medicines Agency has accepted Teva’s Marketing Authorisation Application for olanzapine long-acting i...

June 8, 2026 | Monday | News
Amgen Receives EC Approval for IMDYLLTRA in Extensive-Stage Small Cell Lung Cancer

Amgen has received European Commission marketing authorisation for IMDYLLTRA, or tarlatamab, as monotherapy for adults w...

June 5, 2026 | Friday | News
AbbVie Secures EC Approval for AQUIPTA as Acute Migraine Treatment

AbbVie has received European Commission approval for AQUIPTA, or atogepant, as an acute treatment for migraine in adults...

June 5, 2026 | Friday | News
Vertex’s Povetacicept BLA Accepted by US FDA for IgA Nephropathy

Vertex Pharmaceuticals has received US FDA acceptance of its Biologics License Application for accelerated approval of p...

June 4, 2026 | Thursday | News
Omnix Medical Announces First Patients Dosed in Phase II Trial of Antimicrobial Lead Compound OMN6

Omnix Medical, a biopharmaceutical company developing next-generation anti-infectives for severe multidrug-resistant inf...

June 4, 2026 | Thursday | News
Thermo Fisher Scientific Unveils Next-generation Innovations at ASMS 2026 to Accelerate Drug Discovery

Thermo Fisher Scientific Inc. (NYSE: TMO), the world leader in serving science, announced the Thermo Scientific Orbitrap...

June 3, 2026 | Wednesday | News
Singapore becomes first APAC market to approve MSD's Enflonsia for infant RSV prevention

MSD, trade name of Merck & Co., Inc., Rahway, N.J., USA, has announced that the Health Sciences Authority (HSA) of S...

June 2, 2026 | Tuesday | News
China Formalises Regulatory Data Protection Measures for Drug Applications

On May 15, 2026, China’s National Medical Products Administration (“NMPA”) issued the Implementat...

May 21, 2026 | Thursday | News
SUANNUTRA USA Secures US Distribution Rights for TetraSOD

Nutraceutical ingredients innovator SUANNUTRA USA has inked a distribution agreement with Spanish biotech company Fitopl...

May 20, 2026 | Wednesday | News
AMR innovation faces growing investment gap despite rising global health threat

Antimicrobial resistance (AMR) continues to be recognised as one of the world’s most pressing ...

May 14, 2026 | Thursday | Opinion
Heath Coats Highlights Evolving FDA Inspection Expectations At Charles River APAC Biomanufacturing Leadership Summit

In his keynote session, Heath Coats shared practical regulatory insights drawn from his experience both ...

March 10, 2026 | Tuesday | News
Hong Kong, Sweden collaboration to advance mesenchymal stromal cell therapy for knee osteoarthritis

The InnoHK Centre for Neuromusculoskeletal Restorative Medicine (CNRM), established by The Chinese University of Hong Ko...

February 26, 2026 | Thursday | News
Johnson & Johnson announces breakthrough in Lung Cancer treatment with combination therapy

A new combination therapy has shown promise in extending survival for patients with a specific type of lung cancer in As...

December 6, 2025 | Saturday | News
Zydus and Synthon to commercialise novel 505(B)(2) oncology product in US market

India-based Zydus Lifesciences (including its subsidiaries and affiliates), has signed an exclusive development, licensi...

February 12, 2025 | Wednesday | News
Pfizer launches Rimegepant in Singapore for Acute and Prophylactic Migraine relief

Pfizer’s NURTEC® (rimegepant), an orally disintegrating tablet for both the acute treatment of migraine is now...

January 31, 2024 | Wednesday | News
Junshi Biosciences, Dr. Reddy's to develop and commercialise oncology drug in 21 countries

Shanghai Junshi Biosciences Co. has collaborated with Indian pharmaceutical firm Dr. Reddy’s Laboratories to devel...

May 8, 2023 | Monday | News
Monoclonal antibody drug by GSK Singapore approved to treat chronic rhinosinusitis

GSK Singapore announced that Nucala (mepolizumab), a monoclonal antibody that targets interleukin-5 (IL-5...

February 7, 2023 | Tuesday | News
China approves first and only therapy available for patients with EGFR Exon20 Insertion+ NSCLC

Japan headquatered Takeda's EXKIVITY (mobocertinib) has been approved by the National Medical Products Administration (N...

January 12, 2023 | Thursday | News
Diabetic neuropathic pain field presents significant opportunity for drug developers, says GlobalData

The current diabetic neuropathic pain treatment paradigm includes many established analgesics that provide sym...

December 20, 2022 | Tuesday | Analysis