Lupin receives USFDA approval for Diazepam injection, targets US$ 77.9 million market

The approved product has been determined to be bioequivalent to the reference listed drug Valium Injection 10 mg/2 mL (5 mg/mL) marketed by Hoffmann-La Roche Inc

Lupin gets FDA nod for launch of Generic Sugammadex injection in US market

Bioequivalent version of Merck's Bridion targets the reversal of neuromuscular blockade in adult and pediatric surgical patients

AbbVie’s RINVOQ wins EU approval as first systemic treatment for vitiligo

The approval marks a major shift in the treatment landscape for people living with NSV

Bayer seeks China approval to expand finerenone use for non-diabetic chronic kidney disease

An estimated 850 million people worldwide are living with CKD

EU nod to Pfizer-BioNTech’s updated COVID-19 vaccine targeting XFG variant

Pfizer and BioNTech said the updated monovalent XFG-adapted vaccine generated strong immune responses against currently circulating SARS-CoV-2 lineages

Gland Pharma receives USFDA approval for generic Sugammadex Injection

Day-1 launch targets USD 1.6 billion US market for neuromuscular blockade reversal drug

Sun Pharma receives ANVISA nod for semaglutide injection in Brazil

With an eye on USD 413 million market, the company plans to launch the product in the coming days in partnership with Hypera Pharma, one of Brazil's leading pharmaceutical companies

US FDA approves Cipla's generic Advair Diskus across all three strengths

The approved product is therapeutically equivalent to Advair Diskus, a widely prescribed inhalation therapy indicated for the treatment of asthma and chronic obstructive pulmonary disease

Alembic Pharma receives USFDA approval for generic Prucalopride tablets

Generic version of Takeda's Motegrity addresses US$ 100 million US market

AstraZeneca gets CDSCO nod for expanded Enhertu indication in HER2-positive breast cancer

Approval covers neoadjuvant use of Enhertu in combination with THP for adults with Stage II or III HER2-positive breast cancer.

Philogen resubmits EMA marketing application for Nidlegy with updated Phase III melanoma data

According to the company, the PIVOTAL study demonstrated that Nidlegy reduced the risk of relapse or death compared with the control arm

FDA approves first over-the-counter Tylenol & Naproxen tab for 12-hour pain relief

The approval marks the first time naproxen sodium has been combined with acetaminophen in a single nonprescription tablet

EU panel backs AstraZeneca's Enhertu for metastatic breast cancer treatment

GSK wins FDA approval for Jideytro after Nuvalent acquisition

ROS1-targeted therapy becomes GSK's first marketed lung cancer drug, expanding its oncology portfolio

TSI receives Turkish regulatory authorization to initiate Phase 2 PROMPT-STEMI trial

The authorization permits the study to commence at the clinical centers included in the approved application

Eli Lilly's retatrutide delivers major weight loss results in two late-stage obesity trials

Lilly said it plans to submit a Biologics License Application (BLA) for retatrutide to the U.S. Food and Drug Administration in the first quarter of 2027

Glenmark secures FDA nod to expand RYALTRIS's use for younger children in US

The expanded indication is backed by results from a Phase 3 randomized, double-blind, placebo-controlled study

EU approves JASCAYD: first new IPF treatment for patients with progressive lung disease

Alembic Pharma's partner NATCO secures tentative FDA approval for generic Olaparib tablets

The company to commercialize the oncology drug in the U.S.; reference product Lynparza recorded a market size of nearly USD 1.4 billion

Oh Boey! Allergan Aesthetics wins European approval for fast-acting short-duration wrinkle treatment