News about Regulation

US FDA Approves KEYTRUDA-WELIREG Combination for Adjuvant ccRCC

The US Food and Drug Administration (FDA) has approved KEYTRUDA and KEYTRUDA QLEX in combination with WELIREG for the adjuvant treatment of certain patients with clear cell Renal Cell Carcinoma (ccRCC). The approval expands treatment options for kidney cancer patients at high risk of recurrence following surgery.

Regulation | 15/06/2026 | By News Bureau

US FDA Approves Bayer's AMBELVIST for Contrast-Enhanced MRI

Bayer’s AMBELVIST (gadoquatrane) has received US FDA approval for contrast-enhanced MRI to detect and visualise lesions with abnormal vascularity in the Central Nervous System (CNS) and other body regions. The approval expands advanced imaging options with a next-generation gadolinium-based contrast agent for improved diagnostic evaluation.

Regulation | 15/06/2026 | By News Bureau

US Approves TRUQAP for PTEN-Deficient Metastatic Prostate Cancer

TRUQAP (capivasertib) has been approved in the US as the first targeted treatment for PTEN-deficient metastatic Hormone-Sensitive Prostate Cancer (mHSPC). The approval is supported by phase 3 CAPItello-281 data showing a 19 percent reduction in the risk of disease progression or death.

Regulation | 15/06/2026 | By News Bureau

Alembic Pharmaceuticals Announces US FDA Final Approval for Tretinoin Cream

Alembic Pharmaceuticals has received US Food and Drug Administration (FDA) final approval for Tretinoin Cream USP, 0.05 percent, a generic version of Bausch Health’s Retin-A Cream.

Regulation | 12/06/2026 | By News Bureau

CDSCO Approves AstraZeneca's Trastuzumab Deruxtecan Plus Pertuzumab Combination

AstraZeneca Pharma India has received CDSCO approval for trastuzumab deruxtecan plus pertuzumab as a first-line treatment for adults with unresectable or metastatic HER2-positive breast cancer.

Regulation | 12/06/2026 | By News Bureau

PharmaEssentia Secures Taiwan Approval for BESREMi in Essential Thrombocythemia

PharmaEssentia has received Taiwan approval for BESREMi as the first globally approved treatment for Essential Thrombocythemia (ET), marking the first new approved therapy for the disease in nearly 30 years.

Regulation | 11/06/2026 | By News Bureau

EU Approves Sanofi's Sarclisa SC as First On-Body Injector Cancer Therapy

Sanofi’s Sarclisa subcutaneous has received EU approval as the first anticancer therapy delivered via an On-Body Injector (OBI). Administered through the CirCLIQ OBI, the treatment offers flexible home or outpatient use for multiple myeloma patients while maintaining efficacy across all approved Sarclisa indications and combinations.

Regulation | 09/06/2026 | By News Bureau

US FDA Approves Pfizer's HYMPAVZI for Treatment of Additional Hemophilia A and B Patients

Pfizer’s HYMPAVZI has received expanded US FDA approval for hemophilia A and B patients aged 12 years and older with inhibitors, as well as children aged 6-11 years with or without inhibitors. The approval makes HYMPAVZI the first subcutaneous non-factor therapy available for pediatric hemophilia B patients ages 6 to 11 years old.

Regulation | 09/06/2026 | By News Bureau

Zai Lab Secures China Approval for TIVDAK

Zai Lab has received China NMPA approval for TIVDAK (tisotumab vedotin), the first Antibody-Drug Conjugate (ADC) approved for previously treated recurrent or metastatic cervical cancer in China. The approval is supported by phase 3 innovaTV 301 trial data demonstrating a statistically significant overall survival benefit.

Regulation | 09/06/2026 | By News Bureau

Mabwell's 9MW5211 Gains NMPA IND Clearance for Inflammatory Bowel Disease

Mabwell’s 9MW5211 has received IND clearance from China’s NMPA for the treatment of Inflammatory Bowel Disease (IBD). As the first drug candidate globally targeting this novel mechanism to enter clinical development, 9MW5211 represents a significant advancement in the search for innovative therapies for IBD patients.

Regulation | 08/06/2026 | By News Bureau