FDA delays AstraZeneca decision on camizestrant as regulators seek more data

The filing is backed by results from the pivotal SERENA-6 Phase III trial

Lupin secures FDA nod for generic Sutab tablets with 180-day exclusivity

The approved product is the generic equivalent of Sutab® Tablets developed by Azurity Pharmaceuticals

Lupin’s Ankleshwar facility receives EIR from U.S. FDA

The Establishment Inspection Report came following closure of a product- specific pre-approval inspection from March 2 to March 7, 2026

China greenlights Boehringer Ingelheim’s HERNEXEOS for aggressive lung cancer

The decision clears the drug as a monotherapy for adults with unresectable, locally advanced or metastatic non-small cell lung cancer

Merck’s KEYTRUDA combo wins key EU backing for bladder cancer treatment

The decision now moves to the European Commission, with a final ruling expected by the third quarter of 2026

Datroway wins US nod in aggressive breast cancer subtype

Clearance marks major shift beyond chemotherapy

EU regulator backs Allergan Aesthetics’ Boey in key step toward approval

The decision marks a key step in the centralized EU review process

Venus Remedies secures global approval for Plerixafor in Saudi Arabia

SFDA nod marks company’s strategic entry into high-value specialty oncology injectables as it targets expanding stem cell transplant and haemato-oncology market in the GCC region

Alembic Pharma receives USFDA nod for generic Levothyroxine sodium tablets

Approved product is therapeutically equivalent to Synthroid of AbbVie and is indicated for the treatment of congenital or acquired hypothyroidism

Lupin enters China market with approval for Oseltamivir oral suspension

The approval has been secured in partnership with Yabao Pharmaceuticals, a major player in China’s paediatric medicine segment

Lupin gets tentative FDA nod for Revefenacin inhalation solution

The drug is indicated for the maintenance treatment of patients with Chronic Obstructive Pulmonary Disease (COPD)

Bayer’s stroke drug wins fast-track review in US

The development comes as stroke remains one of the world’s biggest health threats

FDA expands Enhertu use in early HER2-positive breast cancer

AstraZeneca highlighted the move as a major step toward earlier intervention in curable disease

FDA grants accelerated approval to BEQALZI for relapsed mantle cell lymphoma

Astrazeneca’s Baxfendy wins US approval as first-in-class hypertension drug

Baxfendy works in a fundamentally different way from current therapies

Caplin Steriles receives USFDA approval for generic foscarnet sodium injection

Antiviral injection addressing CMV and HSV infections had US market sales of nearly $15 million in the last 12 months

Lupin receives USFDA nod for Famotidine injection

Famotidine Injection USP is a generic version of Pepcid injection to be manufactured at its Nagpur facility for the U.S. market

Indoco Remedies' Baddi plant gets EU GMP approval from Malta Medicines Authority

The certification follows an inspection conducted by the Malta Medicines Authority between January 29, 2026, and February 3, 2026

Alembic Pharma receives USFDA tentative approval for Darolutamide tablets

Darolutamide Tablets, 300 mg, had an estimated market size of US$ 3,155 million in the United States

Pfizer scores landmark EU approval for hemophilia drug HYMPAVZI

The decision marks a significant expansion for Pfizer’s once-weekly injectable therapy