News about Regulation

IntraBio Submits EMA Variation Application for AQNEURSA in Ataxia-Telangiectasia

IntraBio has submitted a variation application to the European Medicines Agency (EMA) for AQNEURSA as a treatment for Ataxia-Telangiectasia. If approved, it would become the first authorised therapy for this disorder in the European Economic Area.

Regulation | 06/06/2026 | By News Bureau |  107

Alembic Pharma Receives USFDA Approval for Haloperidol Tablets

Alembic Pharmaceuticals has received final US FDA approval for Haloperidol Tablets USP in multiple strengths. The medication is indicated for the management of psychotic disorders and the treatment of tics and vocal utterances associated with Tourette’s Disorder in both children and adults, expanding Alembic’s US CNS product portfolio.

Regulation | 05/06/2026 | By News Bureau |  123

US FDA Releases Draft Guidance to Accelerate Cell and Gene Therapy Development

The US FDA has issued draft guidance aimed at accelerating the development of cell and gene therapies by enabling sponsors to leverage existing scientific evidence, reduce redundant testing for treatments targeting rare and life-threatening diseases.

Regulation | 04/06/2026 | By News Bureau

WHO Invites Medicine Submissions to Expand Substance Use Disorder Treatment

The World Health Organization (WHO) has invited manufacturers to submit medicines for prequalification to help expand access to treatments for substance use disorders, addressing a major global public health challenge.

Regulation | 04/06/2026 | By News Bureau

EU Approves AQUIPTA for Acute Migraine Treatment in Adults

The EC has approved AQUIPTA (atogepant) for the acute treatment and prevention of migraine in adults, based on phase 3 ECLIPSE trial results demonstrating rapid pain relief, sustained efficacy, and consistent benefits across multiple migraine attacks. The approval expands AbbVie’s migraine treatment portfolio across EU.

Regulation | 03/06/2026 | By News Bureau

US FDA Accepts NDA for Genentech's Giredestrant in ER-Positive Early-Stage Breast Cancer

The US FDA has accepted Genentech’s New Drug Application (NDA) for giredestrant, an investigational oral SERD for ER-positive early-stage breast cancer. Supported by positive phase 3 trial results, giredestrant is the first and only oral SERD to demonstrate efficacy in the curative setting.

Regulation | 03/06/2026 | By News Bureau

Bristol Myers Squibb Secures FDA Priority Review for Camzyos

The US Food and Drug Administration (FDA) has accepted Bristol Myers Squibb’s supplemental New Drug Application (NDA) for Priority Review (PR) of Camzyos (mavacamten) to treat adolescents with symptomatic obstructive hypertrophic cardiomyopathy (oHCM).

Regulation | 02/06/2026 | By News Bureau |  119

Lupin Receives US FDA Approval for Sodium Sulfate, Magnesium Sulfate and Potassium Chloride Tablets

Lupin has received US FDA approval for its Sodium Sulfate, Magnesium Sulfate, and Potassium Chloride Tablets, a bioequivalent to Reference Listed Drug (RLD) Sutab Tablets of Azurity Pharmaceuticals.

Regulation | 02/06/2026 | By News Bureau

UK MHRA Approves Rilzabrutinib for Adults with Immune Thrombocytopenia

Rilzabrutinib has been authorised in the UK for the treatment of adults with immune thrombocytopenia who have had an insufficient response to previous therapies, providing a new treatment option for this rare autoimmune bleeding disorder. The UK MHRA will continue to closely monitor the medicine’s safety and effectiveness following approval.

Regulation | 01/06/2026 | By News Bureau

US FDA Grants Breakthrough Therapy Designation to Calderasib for KRAS G12C-Mutant NSCLC

Calderasib has received US FDA Breakthrough Therapy Designation for certain patients with newly diagnosed metastatic KRAS G12C-mutant Non-Small Cell Lung Cancer (NSCLC), supported by promising phase 1 KANDLELIT-001 trial data highlighting its potential as a next-generation, highly potent and selective KRAS G12C inhibitor.

Regulation | 30/05/2026 | By News Bureau |  121