Pharma News

In a significant regulatory achievement, Alembic Pharmaceuticals has successfully cleared a Good Manufacturing Practices (GMP) inspection conducted by Brazil’s health regulatory authority, ANVISA, for its API-III manufacturing facility located at Karakhadi, Gujarat.

According to the company’s regulatory filing submitted to stock exchanges on May 15, 2026, the inspection was carried out from May 11 to May 15, 2026, and concluded without any observations.

India-based pharmaceutical giant Dr. Reddy's Laboratories has announced the launch of its generic Semaglutide Injection in Canada, becoming one of the first companies to introduce the product in the Canadian market following approval from Health Canada.

The World Health Organization has officially declared the ongoing Ebola outbreak in the Democratic Republic of the Congo and Uganda a “Public Health Emergency of International Concern” (PHEIC), raising global alarm over the rapid spread of the deadly virus across Central Africa.

The U.S. Department of Commerce has launched a new application process that could allow pharmaceutical companies to significantly reduce looming Section 232 tariffs if they commit to moving drug manufacturing operations to the United States.

Genentech has announced that the U.S. Food and Drug Administration (FDA) has approved Tecentriq and Tecentriq Hybreza for the adjuvant treatment of adults with muscle-invasive bladder cancer (MIBC) who show circulating tumor DNA molecular residual disease (ctDNA MRD) after bladder removal surgery. The approval marks the first FDA-cleared ctDNA-guided therapy approach for this aggressive cancer type.

The U.S. Food and Drug Administration (FDA) has announced a new initiative aimed at accelerating the repurposing of already approved medicines to treat diseases with significant unmet medical needs, including rare disorders, neurodegenerative diseases, metabolic conditions, and substance use disorders.

OneSource Specialty Pharma Limited has announced a strong recovery in its fourth quarter performance for FY26, driven by growth across all major business segments and the commercial launch of semaglutide products in India. The company also reaffirmed its FY28 guidance of achieving nearly USD 400 million in organic revenue with around 40% EBITDA margin.

-- Biogen Inc. (Nasdaq: BIIB) today announced the successful completion of the acquisition of Apellis Pharmaceuticals, Inc. (Nasdaq: APLS). Apellis, a leader in advancing treatments for serious, complement-driven diseases, is now a wholly owned subsidiary of Biogen.